News Coverage

The Partnership for Safe Medicines has been publishing information about the counterfeit drug problem around the world for more than a decade. With experts leading the organization and a committed and passionate set of writers and editors, our content is more in-depth than many other sources, which simply copy links to the news from other websites.

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FDA Releases Video on Counterfeit Detection Device 3

May 13, 2013

The FDA has released more information about their new counterfeit drug detection device, Counterfeit Detection Device 3 (CD-3). In this newly-released video, Nico Ranieri, the FDA research biologist who developed this new technology talks about how important such innovations are to patient safety.

In
2005, it first occurred to Nicolas Ranieri to try to use the type of
ultra-violet light devices deployed in crime scene investigations in a
hand-held counterfeit drug detection device. 
Up to that point, drug testing equipment was both delicate, expensive, and
also required highly-trained scientists to 
perform the tests for fakes.  Says
Ranieri, “We wanted to find counterfeits, and we wanted to find them as fast as
possible,” reports the FDA.

Rx360 Launches Physician Education Campaign on the Risks of Counterfeit Drug Wholesalers

May 13, 2013

Rx360 has launched a new campaign educating healthcare providers to the risks of buying diverted and suspect products advertised directly to doctors’ offices via fax blast, direct email and online marketing.

Lewis T. Kontnik, team lead for the education campaign, says, “Some of the recent
problems with counterfeit and diverted medicines in the US, including
the counterfeit versions of Avastin, resulted in part from a lack of
awareness by physicians and medical practice administrators
of the risks of counterfeit and diverted medicines. The ads of the
professional diverters can appear tempting when they promise ‘genuine’ medicine and substantial discounts, however the facts are different and
the consequences can be very serious.”

Raid on London Apartment Finds Three Quarters of a Million Dollars in Fake Drugs

May 8, 2013

When London police raided an apartment in west London last month, they were looking for visa cheats. What they found instead was over $750,000 worth of counterfeit medications stored in deplorable conditions.

A raid by Home Office Immigration Enforcement officers in West London that was aimed at catching people who had overstayed their visas instead found a vast quantity of unlicensed prescription medications, reports the MHRA. Investigators from the MHRA believe the drugs, which were mostly ED, weight loss, and hair loss treatments, were manufactured in India. Anabolic steroids were also found in the raid.

Fake Botox on the Rise in US as FDA Warnings and Recent Arrest Indicate

May 7, 2013

In 2012, the FDA sent over 350 warning letters to doctors advising them they may have purchased fraudulent or misbranded injectable drugs, including fake versions of Avastin, Botox, and two different osteoporosis treatments. Now the FDA has identified another batch of fake Botox that is currently being marketed to doctor via fax blast.

On April 26, 2013, the US Food and Drug Administration (FDA) posted a drug safety warning for healthcare practitioners, warning them that fraudulent versions of the anti-wrinkle treatment Botox are being marketed and sold in the US. The Botox is being sold by unlicensed suppliers, and has not been vetted within the secure U.S. supply chain. They state that the FDA “cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards. These fraudulent products are considered unsafe and should not be used.

LD 171 and LD 449 will expose Mainers to counterfeit drugs

May 7, 2013

Two proposals in the Maine legislature (LD 171 and LD 449) to import drugs from all over the world would endanger Maine patients without saving them any money.  Maine patients would end up having their prescriptions filled by foreign companies that aren’t licensed pharmacies and sell drugs that aren’t even FDA-approved, assuming they didn’t get counterfeit drugs with either chalk or toxins.

For a serious condition, such as high blood pressure, asthma, and blood clots, even medicine made of chalk is a dangerous pill.

Click here for instructions to call the Maine Legislative Committee considering this legislation now.

New Internet Domain Name .PHARMACY Will Foster Patient Safety

May 1, 2013

In light of the threat of illegal online pharmacies, the National Association of Boards of Pharmacy (NABP) announced their application to the Internet Corporation for Assigned Names and Numbers (ICANN) to own and operate a secure and vetted .PHARMACY domain for licensed Internet pharmacies.

The April 2013 report from the National Association of Boards of Pharmacy (NABP) illustrates the patient safety threat from illegal online pharmacies by showing that of more than 10,000 Web sites they analyzed, nearly 97% operate out of compliance with pharmacy laws and practice standards established in the US. To combat that threat, they have announced their application to ICANN for .PHARMACY, which will be available only to legally operating online pharmacies, who follow the rules and regulations in the jurisdictions in which they are based.

Operator of Canada Drugs Subsidiary Pleads Guilty in Counterfeit Drugs Case

April 30, 2013

When counterfeit cancer medication was found in US distribution at doctors’ offices throughout the country, the source of the fake drugs was traced to Canada Drugs affiliate, Montana Healthcare Solutions (MHS). Now the Wall Street Journal is reporting that a man who marketed the fake cancer drugs to US doctors is due to plead guilty to felony charges in the case.

On March 21, 2013, Paul Bottomley, a UK citizen and founder of Montana Healthcare Solutions, signed a plea agreement wherein he accepted his guilt for his role in the distribution of counterfeit cancer medication, reports the Wall Street Journal. According to the  Plea Agreement, Bottomley waved the right to a jury trial and agreed to plead guilty to misprision of a felony, or aiding in the commission of a felony. The plea agreement also states that Bottomley “maintains he can provide substantial assistance to the United States” and in so doing, further reduce his sentence.  

Bottomley had previously agreed to forfeit the proceeds of his business to the Federal Government, including land and an ostentasiously expensive Aston Martin, sold at auction for $110,000, reports the Missoulan.

Bottomley initially denied any connection to the fake Avastin distribution, telling CBS news via text that Montana Healthcare Solutions had shut down in 2010, and that he “knew nothing of this Avastin matter.” Subsequent investigations however linked him to the sale of the fake Avastin. CBS reports further that a doctor they spoke to received a price sheet in 2011 from MHS with Bottomley listed as the “Business Development Director.”

Back in February 2012 when the FDA first reported that counterfeit Avastin had been found at US doctors’ offices, they identified Montana Healthcare Solutions as one of the suppliers. At that time MHS’s links to online pharmacy giant Canada Drugs were not as yet understood. In July of 2012, the Wall Street Journal linked the two companies in print for the first time. Montana Healthcare Solutions has since been identified by the FDA as “owned and operated by Canada Drugs.”

In related news, The Winnepeg Sun is reporting that Canada Drugs has laid off hundreds of employees in the wake of the FDA’s efforts to shut down their US operations.

To learn more about the safety of purported Canadian Internet pharmacies, and to insure that your medicine stays safe read “The 5 Secrets Canadian Web Pharmacies Don’t Want You To Know.” 

To learn more about the counterfeit Avastin case, and check to see if your doctor received a warning letter from the FDA about fake cancer medication, read our Update on Fake Avastin.

United Nations Report on East Asian Organized Crime: Criminal Made $5 Billion in Fake Drug Profits

April 23, 2013

The United Nations Office on Drugs and Crime (UNODC) has just released their report on organized crime activities in East Asia. It shows counterfeited/ fraudulent pharmaceuticals are a growing source of profit for criminal gangs, and countries with lax enforcement are the biggest market fraudulent medicines.

Oklahoma Clinic Owners Sentenced in Misbranded Drugs Case

April 19, 2013

  The Oklahoma Male Clinic offered treatment specifically tailored for men, but with little regard for patients’ health or medical history. The two owners of the clinic chain have now been sentenced to probation for selling misbranded drugs, and their business shuttered by Federal agents. On March 19, 2013 two men, Michael Schueter and Thomas…

British Fake Pharmacy Actually Selling Counterfeit Drugs From Pakistan: Four Sentenced

April 18, 2013

4 Wales residents were sentenced in a counterfeit drugs case spanning Europe. The four accepted delivery of counterfeit & illicit drugs from Pakistan, which they then repackaged and shipped to online customers in the European Union.

On March 27, 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom announced the sentences of 4 defendants in a counterfeit drug operation spanning from Wales to Pakistan.

Ray Richardson show information

April 12, 2013

CanaRX on the Ray Richardson show on Mon 4/15/2013 @ 7am EST This coming Monday morning 4/15/2013 @ 7am EST the Ray Richardson show is going to talk about importing drugs and have, as a guest, CanaRX, the company that fills Mainers prescriptions by passing them along to unlicensed pharmacies in other countries to be…

Four Men Indicted in Mojo Nights Misbranded Dietary Supplement Case

April 10, 2013

Over the last year the FDA has sent our numerous warnings about the dietary supplement “Mojo Nights” for containing unacknowledged prescription medication. Now four people who marketed and sold Mojo Nights have been indicted for distribution of misbranded drugs.

The FDA first warned the public about the Mojo Nights dietary supplements in May 2012, advising consumers to “stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.”

2 Rhode Island Men Plead Guilty in International Fake Internet Pharmacy Scheme

April 8, 2013

Rhode Island pair pleaded guilty to being part of an international criminal enterprise based in Israel that imported steroids and misbranded pharmaceuticals into the United States for sale via the Internet. The drugs were repackaged and shipped from their facility in Rhode Island.

The US Department of Justice (DOJ) reported on March 13th that two Rhode Island men, Edmond Paolucci, and Patrick Cunningham have pleaded guilty to receiving, repackaging and shipping steroids and misbranded prescription drugs to Internet customers who placed orders with the Israel-based Internet pharmacy.

Justice Department Dismantles Fake Online Pharmacy Conspiracies & Convicts 9

April 3, 2013

On March 27, the US Department of Justice announced the sentencing of 9 people involved in distinct but interrelated fake online pharmacy conspiracies. The ringleaders were sentenced to 4-5 years apiece, while other members of the broad organizations got less jail time or probation. All told, the defendants forfeited more than $94 million in profits. UPS & FedEx shipping records were used as evidence in this case.

The Department of Justice (DOJ) has concluded the successful prosecution of two different fake Internet pharmacy conspiracies. As they describe it, “these convictions were the result of a lengthy investigation by the Drug Enforcement Administration, San Francisco Field Division’s Financial Investigative Team. The prosecution is part of the Northern District of California United States Attorney’s Office’s Health Care Fraud program and was initiated as an investigation with the Organized Crime and Drug Enforcement Task Force. Substantial assistance was provided by the North Carolina Board of Pharmacy. Assistant United States Attorneys Kirstin Ault, Thomas Stevens, and Tracie Brown, with assistance from Denise Oki, Maryam Beros, Rawaty Yim, and Rayneisha Booth, prosecuted this case on behalf of the United States.”

Pitcairn Internet Pharmacy

Michael Arnold, founder of Pitcairn Internet Pharmacy was given a 5 year jail term for his role in distributing controlled substances and prescription drugs through a maze of illegal Internet pharmacy websites. From 2003-2007, he earned more than $69 million via websites such as ezdietpills dot net, pillsavings dot com, and doctorrefill dot net. Arnold used accounts in several countries including Canada, Switzerland, and the Netherlands to launder profits from his illegal drug sales. In addition to his jail term, he has been ordered to forfeit the $69 million in profits from his fake online pharmacy business, reports the DOJ.

SafeScripts/PharmacyUSA

Christopher Napoli, the founder of SafeScripts (also known as PharmacyUSA) was sentenced to 4 years in jail and required to forfeit almost $25 million in profits from his illicit online pharmacy business. Napoli ran his fake Internet pharmacies from November 2004 to December 2006. During that time, Safescripts sold more than 13 million doses of controlled substances. Napoli’s Safescripts operation was rather sophisticated, paying affiliates in several foreign countries to market his drugs, and utilizing a call center in the Dominican Republic to handle customer calls, according to the sentencing document.

UPS Agrees to $40 Million Fine in Fake Online Pharmacy Case

April 1, 2013

United Parcel Service has agreed to pay a $40 million fine for their failure to stop fake online pharmacies from using their service. They have also agreed to implement safeguards in the shipping systems going forward to prevent drug counterfeiters from using UPS to ship their products.

On March 29, 2013, the US Department of Justice announced a non-prosecution agreement with United Parcel Service (UPS) in which UPS agrees to pay a fine of $40 million to the Federal government, and also implement compliance procedures to ensure they no longer ship illicit and counterfeit drugs for illegal online pharmacies, reports Fox Business.

According to the Department of Justice (DOJ), “UPS has cooperated fully with the investigation and has already taken steps to ensure that illegal Internet pharmacies can no longer use its services to ship drugs. These voluntary improvements will be strengthened by the compliance program UPS will implement as a condition of this NPA.”

Billing Insurance Companies for Imported Drugs Is a Crime

March 27, 2013

Billing Insurance Companies for Imported Drugs is a Crime In November 2012, Tennessee oncologist William Kincaid pled guilty to purchasing cancer drugs from unauthorized distributors who were hawking counterfeit drugs with no active ingredient.  Dr. Kincaid deprived his patients of needed cancer treatments and endangered their lives, but–as with Al Capone–the Federal government’s case against him…

$3.6 Million of Fake Drugs Seized in South Carolina Warehouse

March 21, 2013

Special agents with the US Immigration and Customs Enforcement Homeland Security Investigations (ICE-HIS) seized approximately $ 4 million worth of counterfeit goods and pharmaceuticals in South Carolina.

The seizure was the result of an investigation that began February 19th. Investigators from ICE-HSI, the South Carolina Secretary of State’s Office, Blazer Investigations and Pfizer found a stockpile of counterfeit goods in a warehouse in Columbia. The bulk of the seized counterfeit items were counterfeit pharmaceuticals, according to the ICE.

FDA Uses Portable Rapid Testing Devices to Insure Patient Safety

March 18, 2013

The FDA has released photographs of a portable XRF analyzer designed to screen dietary supplements for toxic metals. The device is one of a new generation of portable screening tools, which will allow investigators to discover and seize adulterated drugs before they are available to consumers. The FDA’s new efforts rely on spectroscopic technologies that “analyze the dispersion of an object’s light determine the object’s chemical or molecular composition.”

Mexican Senate Increases Penalties for Medicine Counterfeiters

March 18, 2013

The Mexican Senate voted on March 12 to increase penalties to counterfeit drug sellers to nine years in prison and fines of up to 3 million pesos.

The Senate approved an amendment to article 464 of The General Health Law to increase penalties with 90 votes in favor.  Senate Health Committee President Maki Esther Ortiz Dominguez said, “Anyone who sells or offers for sale, trades, distributes or transports medicine, drugs, raw materials that are falsified, altered, contaminated or adulterated, either in stores or in any other place….will be subject to the same penalty,” reported The News.

UNODC Conference Highlights Fake Drugs Distributed by Organized Crime

March 12, 2013

Last month, the United Nations Office on Drugs and Crime (UNODC) held a conference in Vienna to discuss the the production, distribution and trafficking of fake drugs by organized crime networks.  The conference, which was held February 14-15, gathered an international group of experts from governments, law enforcement agencies, NGOs and the private sector to share information about the scale of the problem, which has significant impact worldwide. UNODC has found that in parts of Asia, Africa and Latin America as much as 30 percent of available drugs are fraudulent, and that the trafficking of unsafe or ineffective medicine is “a multi-billion dollar activity.”

PSM Applauds INTERPOL, Industry Partnership to Combat Counterfeit Medicines

March 12, 2013

March
12, 2013 (Washington, D.C.)
The Partnership for Safe Medicines
(PSM), the leading advocacy organization dedicated to fighting the spread of
counterfeit drugs, applauds today’s
announcement
of a bold new initiative between INTERPOL
and the pharmaceutical industry to combat the global health threat of
counterfeit and fake medicines.

This new initiative broadens the scope of the
successful Medical Product Counterfeiting and Pharmaceutical Crime Unit through
the creation of a Pharmaceutical Crime Program to assist and enhance worldwide
law enforcement efforts. Thomas Kubic, PSM Board Member and CEO of the
Pharmaceutical Security Institute, released the following statement hailing the
new agreement:

How Did That Canadian Pharmacy Medicine Get To Me?

March 7, 2013

How Did That Canadian Web Pharmacy Medicine Get to Me?

So called “Canadian” online pharmacies pretend to sell non-Canadians price-controlled medications for citizens. Evidence collected by the U.S. Food and Drug Administration questions their claim.

Recent Efforts by Chinese Government to Crackdown on Counterfeit Drugs Show Progress

March 3, 2013

Though China has long been linked to the manufacture of counterfeit drugs, the last two years have shown that Chinese authorities are taking counterfeit drug crime much more seriously. China’s Food and Drug Administration (SFDA) cracked over 14,000 cases last year, a major toxic gel capsule ring was broken up, and Chinese authorities are working in concert with both the FDA and major drug manufacturers to track down counterfeit drug manufacturers and prosecute them. The founding of Partnership for Safe Medicines China also demonstrates China’s stakeholders’ commitment to improving patient safety both at home and abroad.

China made great strides in the last year in their efforts to combat pharmaceutical counterfeiting. Their cooperation with the US Food and Drug Administration on inspections is helping to safeguard both US and Chinese consumers. The founding of Partnership for Safe Medicines China underscores a new commitment to ensuing drug safety within their borders. Partnership for Safe Medicines China is the latest branch of the leading advocacy organization dedicated to fighting the global threat posed by counterfeit and misbranded drugs.

National Boards of Pharmacy Releases 2013 Report, 97% of Online Pharmacies Not Recommended

March 3, 2013

The National Association of Boards of Pharmacy (NABP) has released their 5th annual report on Internet Drug Outlets. Published each year, it is a progress report for state and federal regulators that illustrates the state of online drug sales in the United States and the overwhelming dominance of fake online pharmacies in the global Internet marketplace.

As of March 4, 2011, NABP surveyed 10,275 internet pharmacies and found that 9,938 or 97% were classified as “Not Recommended”, meaning they did not comply with NABP patient safety and pharmacy practice standards, or state and federal laws.

UK’s Medicine Regulatory Agency Warns of Dangerous Ingredients in Herbal Remedies

February 26, 2013

On February 19th, 2013 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) posted a press release warning of dangerous heavy metal contamination in unlicensed Chinese herbal medications produced in Hong Kong and sold internationally online. The herbal compounds are reported to contain mercury and lead, which can lead to health side-effects ranging from dizziness to kidney and brain damage, reports the MHRA.

The MHRA, which is the UK counterpart to the US Food and Drug Administration (FDA), states that the following products: “Bak Foong Pills – used to relieve menstrual discomfort, Fung Shing Paij Tian-Ma Wan – used to relieve arthritis and headaches, and Shi Hu Ye Guang Wan and Nai Chang Ming Yan Pills – both used to improve vision in adults” are all contaminated with either lead or mercury.

Avoid the Top 3 “Natural” Products That Threaten Your Heart

February 26, 2013

Before buying the next miracle cure for weight loss, joint pain, or intestinal distress, ask yourself, is it heart-smart to take a dietary supplement you know nothing about?

Heart disease is the number one cause of death in the US for both men and women.

In the last few years, some truly unexpected drug compounds that cause heart ailments have turned up in herbal dietary supplements despite claims to be “safe and all natural.” To honor American Heart Month, take the pledge to guard your heart by being a smart shopper and only taking dietary supplements when you know the ingredients are safe.

Learn more about the top three herbal supplement ingredients that are neither natural nor herbal.

Institute of Medicine Releases Report on Falsified and Substandard Drugs

February 19, 2013

On February 13, 2013, the Institute of Medicine (IOM) released
their report, “Countering the Problem of Falsified and Substandard Drugs” that
reviews the current state of substandard and falsified drugs globally, and offers
a series of recommendations to combat drug falsification and to encourage
global cooperation on drug safety.

Food and Drug Administration Commissioner Dr. Margaret
Hamburg commends the FDA commissioned report because it “spotlights a critical global public health
issue. Falsified and substandard medicines adversely affect the lives of
millions around the world, and the issue must be elevated to the highest levels
of international discourse.”

Partnership for Safe Medicines India Rolls Out Drug Verification Project for Patients

February 19, 2013

On February 15, 2013 at the India Habitat Centre in New Delhi, the Partnership for Safe Medicines India proposed an initiative “to study the extent of spurious and not-of-standard medicines in India and adopt policies to ensure safety and quality in the supply chain.”

An unprecedented pilot program supported by the PSM India will provide low-cost medicine evaluation for patients at accredited government approved laboratories. The goal of the pilot program is to “establish trust on the quality and existing regulatory standards between the manufacturers and the consumers,” said P. D. Sheth, VP, International Pharmaceutical Federation.

New Counterfeit Avastin Found – Medical Practitioners Advised by FDA to Be Wary of Unfamiliar Wholesalers

February 12, 2013

Breaking News: US Food and Drug Administration (FDA) has identified a third batch of counterfeit cancer medication in the United States. On February 5, 2013, the FDA posted a health practitioner warning about this latest counterfeit version of the cancer treatment Avastin.

According to the FDA “lab tests have confirmed that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the United States contains no active ingredient.” The counterfeit drugs allegedly have been distributed by New York-based supplier, Medical Device King/Pharmalogical, reports the FDA warning. This is the first time a US drug supplier has been implicated in the distribution of counterfeit cancer drugs.

Influenza Outbreaks Inspire Drug Counterfeiters to Exploit Anxious Populace

February 12, 2013

7,224 hospitalizations for laboratory-confirmed flu cases have occurred in the United States since October 1, 2012, according to the US Centers for Disease Control (CDC) Weekly Flu Update. Additionally, a January 25th CDC news release reports that influenza infection rates have been running at least 2 percentage points above epidemic classification for the past three weeks. While the CDC and other public health entities are encouraging consumers to be vaccinated, drug counterfeiters look at the US flu epidemic as a cash-making opportunity, warns the US Food and Drug Administration (FDA).

The FDA’s February 1 consumer update warns “As the flu continues to make people sick—and even cause deaths—scammers are alive and well, promoting their fraudulent products to the unsuspecting public.”

Health Care Provider Alert: Another Counterfeit Cancer Medicine Found in United States

February 8, 2013

This is a reprint of an FDA Alert. Purchasing Unapproved Drugs is Risky Business [2/5/2013] The Food and Drug Administration is committed to protecting the supply chain against counterfeit and unapproved medicines that enter the United States through fraudulent sources. As part of this vigilance, FDA is alerting health care professionals that an unapproved cancer…

Update On Fake Avastin – FDA Warnings in 28 States, Six Prosecutions

February 5, 2013

On February 12, 2012, the FDA sent out a public warning that counterfeit versions of the injectable cancer medication Avastin, had been found in the US drug supply chain. Since that time, a second warning was issued on counterfeits of the Turkish version of Avastin, Altuzan had also been found in the US, five US citizens, including three doctors have been prosecuted for selling or purchasing misbranded cancer medication, and an additional 134 doctors in 28 states have been sent FDA warning letters concerning their dealings with the foreign supplier that was the source of the counterfeit Avastin.

In the last 12 months, the US Food and Drug Administration (FDA) has issued warning letters to 134 US doctors informing them that they may have purchased counterfeit cancer medication. They were warned about purchases of unapproved medications, including unapproved versions of the injectable cancer treatment, Avastin, from wholesale drug distributors operated by foreign suppliers outside US jurisdiction. Each letter sent explained that the foreign drug wholesaler the doctors did business with were the source of the counterfeit Avastin that had infiltrated US drug supplies.

The first warning letters were sent out February 10, 2012 to 19 doctors. In April, two sets of letters, one dated the 5 and the second dated the 23rd, were sent to an additional 59 doctors. On June 28th, 55 more doctors received warnings, bringing to current total to 134 doctors in 28 states. California leads the pack where 57 California doctors were warned by the FDA about counterfeit cancer drug purchases.

The current warnings about counterfeit versions of Avastin or Altuzan were issued on June 28th, 2012. The FDA letter states “The U.S. Food and Drug Administration has received information indicating that your medical practice purchased multiple medications from a foreign distributor named Clinical Care, Quality Specialty Products (QSP), Montana Healthcare Solutions, or Bridgewater Medical. Most, if not all, of the products sold and distributed by this distributor have not been approved by the FDA and may include counterfeit versions of Avastin or Altuzan.”

These most recent warnings were sent to doctors in Alaska, California, Colorado, Florida, Georgia, Illinois, Kentucky, Michigan, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, and West Virginia.

US Counterfeit Drug Distributor Sentenced in Los Angeles

February 4, 2013

A Puerto Rican man who acted as a distributor for a counterfeit drug criminal gang was sentenced in Federal court this month. Originally facing 10 years, he has been sentenced to 2 years in prison for his role in a massive counterfeit drug ring operating in the United States

Francis Ortiz Gonzalez was convicted of conspiracy and seven counts of trafficking in counterfeit pharmaceuticals in August of 2012. According to the U.S. Immigration and Customs Enforcement (ICE) news release on the occasion of his sentencing, “federal agents executed a search warrant at Ortiz Gonzalez’s residence in Trujillo Alto, a suburb of San Juan, Puerto Rico. Inside the home, investigators found more than 100,000 pills that resembled a variety of popular prescription medications.” Ortiz Gonzalez shipped more than 140,000 counterfeit pills from China to individuals throughout the United States, found the investigators.

China Making Strides on Counterfeit Drugs; Offers Reward for Information, Works with US FDA on Enforcement

January 29, 2013

In an effort to stem the tide of fake drugs being produced in their country, China’s Food and Drug Administration (SFDA) offers a bounty of $50,000 US to those who report counterfeit drug production. This comes on the heels of recent success by the SFDA in shutting down counterfeit drug websites catering to Chinese-speakers.

China’s Food and Drug Administration has begun offering an increased bounty to anyone who reports counterfeit drug production to the agency. On January 17th the SFDA (on their English-language website site) stated “To encourage the public to report illegal activities so as to discover, control and eliminate potential safety risks concerning food and drug in time, and to crack down on illegal and criminal activities concerning food and drug, the State Food and Drug Administration (SFDA) and the Ministry of Financial of China recently jointly issued the Reward Measures for Reporting Illegal Activities Concerning Food and Drug.”

How Safe Are Your Osteoporosis Drugs? Where Did Your Doctor Buy Them?

January 24, 2013

The US Food and Drug Administration (FDA) has issued warning letters to 20 US doctors that they have possibly purchased unapproved medications, including unapproved versions of the osteoporosis treatments Prolia and Aclasta, from drug wholesalers owned by suppliers operated by foreign entities outside US jurisdiction. The medical practices were warned that the wholesalers are selling drugs that not approved for sale in the United States and that they may be counterfeit.

The current warning about unapproved versions of the osteoporosis treatments Prolia and Aclasta were issued on September 10, 2012. The FDA letter states “The U.S. Food and Drug Administration has received information indicating that your medical practice purchased multiple medications from a foreign distributor owned and operated by Canada Drugs, known as Montana Healthcare Solutions, Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, Infusion Options, UK Pharmacy Services, or Clinical Care. Most, if not all, of the products sold and distributed by one of these distributors, including versions of Prolia and Aclasta, have not been approved by the FDA.”

Canadian Internet Pharmacy Founder Gets 4 Years in Counterfeit Drugs Case

January 18, 2013

Canadian online pharmacy pioneer, Andrew Strempler, was sentenced January 9th, 2013 to 4 years after he pleaded guilty to one charge of conspiracy to commit mail fraud. Initially, Strempler faced 4 charges relating to the case with each carrying a possible sentence of 20 years.

Strempler’s current legal woes stem from the FDA investigation of his Internet pharmacy business Mediplan Health Consulting Inc, also known as RX-North. According to the Wall Street Journal, FDA investigations of Strempler’s business discovered that 90% of the drugs they had seized from a Mediplan shipment were counterfeit. The shipment contained fake versions of Arimidex, a breast cancer treatment, and Lipitor, the cholesterol drug.

Dallas Area Hospital Among Hundreds Receiving FDA Warning About Unapproved Versions of Botox

January 16, 2013

The FDA has issued warning letters to over 350 US medical practices that they may have purchased unapproved medications, including unapproved versions of Botox from wholesalers owned by foreign suppliers. The medical practices were warned that the suppliers sold drugs not approved for sale by the FDA that may be counterfeit.

In this latest incident of US doctors buying prescription medication for patients from questionable and unapproved sources, doctors in 38 states, and one hospital have received warnings that they have made purchases from an unapproved foreign supplier of medication.  

Legitscript Acts to Take Down Network Parent of Over 200 Fake Online Pharmacies

January 9, 2013

internet pharmacy affiliates run by MyRxCash.com. In December, Legitscript was able to shut down operations for MyRxCash itself, and the hundreds of affiliate websites it had created.

MyRxCash, also known as Pronet, was warned by the FDA in September about their activities. The FDA letter warned Pronet that its “websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed below offer unapproved and misbranded new drugs for sale.”

The Year in Review – Part 2 – Diversion, Black Market and Internet

January 7, 2013

Part 2 of The Year in Review

Fake medications have infiltrated the legitimate supply
chain in the United States in 2012 through doctor’s offices, bricks and mortar
pharmacies and through direct-to-consumer purchasing on the internet. 

Fake drugs containing dangerous ingredients
have been found for purchasing from unlicensed internet pharmacies, and drug
diverters have infiltrated brick and mortar pharmacies with black market medications. 

The Year in Review – Part 1 – Fake Medications in Doctors’ Offices

December 24, 2012

Fake Medications in Medical Offices 

In the past two years, fake doctors were convicted of vitally
endangering the lives of patients who submitted to counterfeit treatments. Patients can keep themselves safe from fake doctors by checking the validity of their physician’s license with the state medical board.  But patients can’t use proof of a valid physician’s license to protect themselves when real doctors administer fake medications.  In the same time period, while two fake doctors were convicted of administering fake drugs to patients, three real doctors were convicted of the same crime.

Products Recalled Due to Undeclared Sildenafil Analogues

December 19, 2012

This is a reprint of an FDA Alert. Recall — Firm Press Release FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. Recall – Performance Plus Marketing…

Florida Man Gets 10 Years For Complex Drug Diversion Scheme

December 17, 2012

Defendant pleaded guilty to purchasing diverted prescription drugs on the black market, then reselling them into legitimacy via Altec Inc.

William D. Rodriguez, of Miami Florida, was sentenced today to 120 months in prison for his role in a complicated drug diversion scam, reports the US Department of Justice. Rodriguez’ illicit business purchased prescription drugs from all manner of sources, such as cargo thefts and patients willing to sell their medication, then repackaged the drugs and created a drug “pedigree” for them before selling them back to consumers. He was also found guilty of money laundering, and was ordered to forfeit $55 million in profits.

Operation Safe Medicine Finds Fake Medicine and Fake Doctor

December 12, 2012

Fake doctor who caused “infliction of great bodily injury” to patients with fake medicine was convicted in San Diego, after they filed complaints with the California Medical Board.

The
Federal Bureau of Investigation arrested Kathleen Ann Helms, also known as
Catherine Bright-Helms, age 57, of Encinitas, CA in August, 2012.  She was charged with practicing medicine
without a license, “which resulted in the infliction of great bodily injury and
grand theft,” announced the FBI.  

Doctor Pleads Guilty in Misbranded Cancer Drug Case

December 6, 2012

US
Department of Justice convicts two in cases tying counterfeit cancer drugs
to Canadian pharmacy business.

On
November 15th, Dr. William Kincaid, of Johnson City, TN, was convicted for
knowingly purchasing non-FDA approved injectable cancer medications from
Quality Specialty Products (QSP). Dr. Kincaid accepted a plea deal with the
federal government in exchange for assisting them with their ongoing
investigation. Previously, Dr. Kincaid’s business manager, Michael Dean Combs
pled guilty in the same case on September 19th, reports
Knox News
.

Partnership for Safe Medicines Announces Groundbreaking China Initiative

November 29, 2012

Launch of PSM China Reinforces Global
Fight Against Counterfeit Drugs

Beijing and Washington, D.C. (November
28, 2012)
– The
Partnership for Safe Medicines (PSM), the leading advocacy organization dedicated
to fighting the global threat posed by counterfeit drugs, today announced its
latest international collaboration with the launch of PSM China. Today’s launch
event in Beijing was attended by stakeholders from the government, advocacy community and industry, and underscores the important
role that public-private partnerships play in educating consumers and helping
to keep them safe from dangerous and deadly counterfeit medicines.

Essex (UK) Fake Online Pharmacy Money Man Sentenced in Counterfeit Drug Scheme

November 26, 2012

MHRA(UK) investigation leads to seizure of 26,000 unapproved prescription pills & steroids, and prosecution of 4 fake online pharmacy operators.

Canvey Island resident Gary Bracci pled guilty to money laundering charges, processing over ₤400,000 in payments for a fake online pharmacy operation. He has been sentenced to 12 months suspended, along with 300 hours of court-mandated unpaid work, and a ₤10,000 fine, announced the MHRA.

FDA Alert: Voluntary Nationwide Recall Of Classic Zi Xiu Tang Bee Pollen Capsules And Ultimate Formula Capsules Due To Undeclared Sibutramine

November 13, 2012

This is a reprint of an FDA Alert. Recall — Firm Press Release FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. Zi Xiu Tang Success, LLC…

Seniors Can Learn to Save Money Safely When Shopping for Medicine Online

November 9, 2012

For older consumers joining the ranks of Internet users, purchasing prescription drugs online presents opportunities for saving, but also dangers from fake online pharmacies.

A recent survey by Pew reports that 70% of Internet users 65 and older are online daily.  A joint study by The Optum Institute and Harris Research discovered that 57% of Internet users over 65 are interested in communicating about their healthcare via the Internet. As more seniors begin looking for healthcare solutions online, including finding medical information and seeking out prescription medications, they are unlikely to easily distinguish verified and authentic pharmacies and health information from fake online pharmacies where counterfeit drug criminals are eager to prey upon them.

FDA Alert: Multistate outbreak of fungal meningitis and other infections

November 2, 2012

Multistate outbreak of fungal meningitis and other infections. FDA provides NECC Customer List. Ameridose recalls all products. This is a summary of the FDA Alerts on fungal meningitis and bacterial contamination in New England Compounding Center (NECC) products and recall of Ameridose products. Bacterial contamination also found in NECC Products. [11-01-2012] The U.S. Food and…

RxResponse Helps Sandy Victims Find Open Pharmacies

November 1, 2012

Recovering from Sandy but in need of vital medication? RxResponse is here to help.

In the wake of disasters such as hurricane Sandy, patients can find out online if their pharmacy is open and accessible by using RxResponse.

Rx Response helps get critical medicines to patients whose health is threatened by a severe public health emergency, such as a natural disaster, terrorist attack, or pandemic, by sharing information and problem-solving for a coalition of bio-pharmaceutical supply chain organizations, disaster relief agencies and local, state and federal government agencies.

Doing Our Part to Protect Patients

October 24, 2012

The following guest blog is provided by Elizabeth A. Gallenagh, Esq., Vice President,
Government Affairs and General Counsel of the Healthcare Distribution
Management Association (HDMA), a PSM member.

The opinions expressed are not necessarily PSM’s policy.

The
U.S. healthcare supply chain remains one of the strongest in the world, but it
is not immune to bad actors and incidents that compromise patient safety and
security. For example, in the past year alone we have seen major headlines of
counterfeit Avastin reaching patients and “gray market” profiteers.

PhRMA and GPhA Standing United Against Counterfeit Medicines at Interchange

October 19, 2012

John Castellani, President and Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA) and Ralph G. Neas, President and Chief Executive Officer, Generic Pharmaceutical Association (GPhA), took the dais together at the Partnership for Safe Medicines 2012 Interchange on September 28, 2012 to discuss the risks of counterfeits to patient safety.

Who is the Criminal Mastermind Behind the Counterfeit Cancer Drug Scare?

October 11, 2012

In February and March 2012, the Food and Drug Administration announced fake cancer drugs had infiltrated the secure US drug supply chain. The investigation into who sold these drugs to US doctors in ongoing.


Seventy-six doctors in twenty-two states
were contacted by the FDA because they may have purchased counterfeit Avastin from a “little-known drug wholesaler, Montana Healthcare Solutions,” reported the Wall Street Journal.

PSM2012: Startling and Compelling Speakers Focused on Patient Safety and Criminal Acts

October 11, 2012

The Partnership for Safe Medicines’ 2012 Interchange on September 28th, 2012 at the National Press Club brought together researchers, patient advocates, law enforcement and industry to discuss the damage counterfeit medications and fake online pharmacies cause to Americans. “This year’s Interchange was our boldest, most ambitious effort to date,” said PSM President Dr. Marvin D.…

Global Sting Operation Shuts Down 18,000 Illegal Online Pharmacies, Seizes 3.75 Million Counterfeit Medicines Worth Over $10.5 Million

October 4, 2012

100 Countries Participate in Operation Pangea V’s Worldwide
Crackdown on Fake Pharmacies and Drugs

The Partnership for Safe Medicines (PSM) is extremely pleased with the conclusion of Operation Pangea V, a worldwide, coordinated sting operation targeting illegal online pharmacies that has yielded spectacular results.

Coordinated by INTERPOL, Pangea V ran from September 25 through October 2 and was a global effort involving the cooperation of law enforcement, customs, health officials and the private sector.

FDA Wants You To Be Safe When Buying Drugs Online

October 1, 2012

FDA launches BeSafeRx, a national campaign to make online pharmacy shopping safer, warning consumers that 97% of pharmacies online don’t adhere to state and federal laws.

In a report carried by the Washington Post, FDA Commissioner Margaret Hamburg has announced a new consumer education campaign, aimed at protecting the American consumer from counterfeit drugs.

Leading Health Care, Law Enforcement and Government Officials Join with Industry and Patient Advocates to Assess State of Counterfeit Medicines

September 28, 2012

U.S. FDA Commissioner Hamburg Urges Physicians,
Patients to Only 
Purchase Medicines from Reliable Sources to
Better Protect Against Fake Drugs

Washington, D.C. (September 28, 2012)The Partnership for Safe Medicines (PSM)
today convened
leading domestic and international stakeholders in the fight
against counterfeit and substandard medicines, making a renewed commitment to
work together and implement new solutions to protect
patients worldwide. U.S. Food and Drug Administration Commissioner Dr. Margaret
Hamburg, in a keynote to the conference, highlighted new efforts her agency is
undertaking to reduce the threat and pledged the FDA’s ongoing support to
ensure a safe U.S. drug supply.

PSM2012: FDA Commissioner Margaret Hamburg’s Keynote Speech

September 28, 2012

Dr. Margaret Hamburg, FDA Commissioner, addressed the Interchange in her keynote speech. Hamburg said that "We need to work together to stay ahead of the many avenues that criminals are finding that are putting the health and safety of American citizen's at risk." Calling them 21st Century snake oil peddlers, Hamburg said that FDA has…

PSM2012: The UK (MHRA) approach to combating Falsified Medicines

September 28, 2012

Gerald W. Heddell, Director of Inspection, Enforcement & Standards Division at the Medicines & Healthcare products Regulatory Agency in the UK, was introduced by Brian Finlay, Senior Associate and Director of Managing Accross Boundaries at The Stimson Center. Heddell began his talk with a map of recent counterfeit incidents worldwide.  And then said, "Since I made this…

PSM2012:Linda Marks, Senior Litigation Counsel, Consumer Protection Branch

September 28, 2012

After Nancy Kennedy, Linda Marks, Senior Litigation Counsel of the Consumer Protection Branch of the U.S. Department of Justice spoke. She also emphasized the international scale of the counterfeit drug problem.  Online reselling of unapproved, illegal and dangerous medications can have too much, too little, no, or the wrong active ingredient. General intellectual property crimes…

PSM2012: Special Agent Nancy Kennedy Talks On International Counterfeit Drug Crime

September 28, 2012

Moderator Brian Finlay introduced speakers for the Drawing Outside Domestic Lines, International Cooperation panel. "Counterfeit medicine is an international human security and serious compelling public health issue." Speaker Special Agent Nancy Kennedy with FDA-OCI handles drug investigations, included counterfeit medicines. Kennedy began by discussing international cooperation between MHRA, two southern European countries and the U.S.…

PSM2012 – PhRMA and GPhA Heads Discuss Counterfeit Medicine

September 28, 2012

Partnership for Safe Medicines’ Executive Director Scott LaGanga introduced John Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America.  PhRMA leads more than 600,000 of America’s leading biopharmaceutical professionals who develop new medicines to help people live longer, healthier lives. He also introduced Ralph Neas, the President and CEO of the Generic Pharmaceutical…

PSM2012 – John Roth, Director of the FDA’s Office of Criminal Investigations

September 28, 2012

John Roth, Director of the U.S. Food and Drug Administration's Office of Criminal Investigations was the luncheon speaker at the Interchange, introduced by Partnership for Safe Medicine's Executive Director Scott LaGanga. Roth spoke on the FDA’s criminal priority areas, its recent experience (and challenges) with combatting counterfeiters, and more broadly about how criminal enforcement fits in with…

PSM2012 – Payment Processing and Unlicensed Online Pharmacies

September 28, 2012

Moderator Linda Johnson, Pharmaceuticals and Health Business writer for The Associated Press, introduced Damon McCoy, researcher from George Mason University.   Said Johnson, "Through my work I’ve learned about the many implications that counterfeit drugs can have on the consumer.  So many people rely on and trust the drug supply chain for safe and effective…

PSM2012 – Scott Williams, Men’s Health Network: Patient perspective on counterfeit medications

September 28, 2012

The opening speaker for the 2012 Interchange was Scott T. Williams, Vice President of Men’s Health Network.  Men’s Health Network (MHN) is a national DC based non-profit organization, founded in 1992, whose mission is to reach men and their families where they live, work, play, and pray with health prevention messages and tools, screening programs, educational…

PSM2012: Opening Remarks and Introductions

September 28, 2012

Partnership for Safe Medicines Executive Director Scott LaGanga welcomed participants to the third annual Interchange, where key stakeholders discuss and begin to solve the global problem of pharmaceutical counterfeiting. Said LaGanga, "We believe that by working together, we can come one step closer to protecting the pharmaceutical supply chain from dangerous counterfeit drugs." Following LaGanga,…

PSM2012 – Sally Greenberg, Executive Director of the National Consumers League

September 28, 2012

Sally Greenberg, the Executive Director of the National Consumers League, spoke on consumer concerns with counterfeit medications. She reviewed cases of counterfeit medicines that had damaged patients' health and spoke of their outrage and incredulity. She also discussed the fact that doctors can't identify fakes from real medication by looking at them, and that patients…

PSM2012 – Technological Strategies: The Last Line of Defense

September 28, 2012

Anthony J. DeStefano, Ph.D. Sr. Vice President, Compendial Science at the United States Pharmacopeia spoke on technological strategies in protecting consumers from counterfeit medications. DeStefano delineated the many challenges to detection.  Said DeStefano, "About 80% of all active pharmaceutical ingredients are made outside the US, and detection of counterfeit or substandard products is often impossible to detect…

PSM2012 – Supply Chain Integrity: The Patient Care Interface

September 28, 2012

David Chen, Director, Pharmacy Practice Sections of the American Society of Health-system Pharmacists spoke after the morning break on Supply Chain Integrity. Chen spoke about the integrity of the drug supply chain and the stressors that create risky behaviors by consumers.  The stressors are affordability, disruptions, access and shortages, said Chen. The top three areas where…

PSM2012 – James Dinkins, Executive Associate Director of ICE’s Homeland Security Investigations

September 28, 2012

James Dinkins, Executive Associate Director of ICE's Homeland Security Investigations (HSI) spoke on the risks to Americans for purchasing medications online from fake websites. Dinkins said that the counterfeit medicine industry has changed and become a global industry, exploiting the easy access of technology to take advantage of consumers. Said Dinkins, "Criminals world wide have…

PSM2012 – A Day in the Life of Illegal Online Drug Researchers

September 28, 2012

Dr. Bryan Liang, PSM Board Member, and E. Donald Shapior Distinguished Professor and Executive Director of the Institue of Health Law Studies, California Western School of Law introduced Tim K. Mackey, Alsberg Fellow for Safe Medicines.   Mackey, a doctoral student at the California Western School of Law, presented original research on Fake Online Pharmacy…

PSM Announces 2012 Guardian Award Winner

September 27, 2012

United
Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)
 Honored for Excellence, Achievement in Fighting
Counterfeit Drug Sellers

Washington, D.C. (September 27, 2012) – The Partnership for Safe Medicines
(PSM) today announced the recipient of the Guardian Award, given annually to
the individual or organization who has demonstrated outstanding leadership in
the fight to stop counterfeit medicines.

Preview of the Interchange

September 27, 2012

The Partnership for Safe Medicines is preparing for tomorrow's Interchange by reviewing speaker presentations, preparing materials, and learning about our colleague's efforts to fight counterfeits globally.  Preparations have been made for more than 160 attendees, which include many journalists, patient safety advocates, government agencies, and law enforcement as well as both branded and generic pharmaceutical manufacturers.…

FDA Develops Hand-held Counterfeit Drug Detection Device

September 27, 2012

The US Food and Drug Administration has introduced a powerful new tool in the war against counterfeit drugs. It’s a hand-held counterfeit drug detection spectrometer that uses light to detect anomalies in drug appearance and packaging.

Called the Counterfeit Detection Device #3, or CD3, it was developed internally by the FDA, and presented at an FDA symposium by Commissioner Margaret Hamburg on September 11th, reports CNN.

Malaysian Health Ministry Says Drug Traffickers Switching from Illicit Drugs to Counterfeits

September 25, 2012

Ministry of Health Assistant Director Mazlan Ismail cites high profits and mild punishments for drug counterfeiting as the cause of this global shift as Malay government considers increasing sanctions for drug counterfeiting crime.

Malaysia’s Sun Daily spoke with Ministry officials and pharmaceutical manufacturing representatives on the occasion of “The Hard Facts Media Workshop, organized by Pzifer Asia.

Master Counterfeiter: Ran Global Drug Counterfeiting Business – Sentenced to 6.5 Years

September 24, 2012

Kevin Xu a citizen of the Peoples Republic of China was sentenced to seventy-eight months imprisonment for distributing counterfeit and misbranded drugs in the United States, on January 1th, 2009.

Xu was sentenced after being found guilty in a jury trial that took place in August 2008. Xu was indicted in 2007, as the result of an undercover investigation conducted by the Department of Homeland Security, Immigration and Customs Enforcement (ICE) and the US Food and Drug Administration Office of Criminal Investigation (FDA).

Xu described to undercover agents his ability to manufacture all manner of brand name prescription drugs, and included a list of 25 different prescription drugs he could produce, including Plavix (used for treating blood clots), Casodex (for the treatment of prostate cancer), and Tamiflu (used for the treatment of influenza) along with several other life-saving drugs.

Xu had been conducting his business throughout Europe, but the investigation that resulted in his arrest only began once he attempted to break into the United States pharmaceuticals market. The US investigation into Xu’s activities uncovered the startling volume of business that he was conducting in the United Kingdom. As a result of this discovery, massive drug recalls were declared by the UK’s Medicines and Health Regulatory Agency (MHRA), and a counterfeit drug distribution ring based in the United Kingdom was apprehended.

MHRA Director of Inspection, Enforcement and Standards, Gerald Heddell, as well as FDA Commissioner Margaret Hamburg, and OCI Director John Roth are all speaking at the 2012 Interchange on September 28, 2012.  

Learn more about the world of counterfeit drug crime and the agencies that are fighting it on behalf of patients.  Register today for your last chance to join in the conversation.

PSM Executive Director Will Present at PDMA Sharing Conference

September 17, 2012

The Partnership for Safe Medicine’s Executive Director, Scott LaGanga, is presenting on Thursday September 20th, at the The PDMA Sharing Conference.  The conference, held at the Gaylord National Hotel and Convention Center in National Harbor, Maryland, is held over three days starting September 19th.  

Mr. LaGanga will bring attendees up to date on the risks and dangers associated with counterfeit drugs, a real concern for American consumers.

Dr. Paul Newton Talks Counterfeit Drugs & Drug Resistance in Recent Interview

September 14, 2012

In a recent interview with Pathogens & Global Health, Dr. Paul Newton, Head of the Welcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration in Vientiane, Laos, offered his expertise on the growing problem of counterfeit medication in the treatment of tropical diseases.

Dr. Paul Newton works in the heart of Malaria country in Southeast Asia. As a result, he has a very clear, first-hand perspective on the role counterfeit and substandard drugs play in drug resistance and the human cost of counterfeit medication. He is also well acquainted with the drug supply chain problems that plague malarious regions.

Office of Criminal Investigations Director John Roth to Speak at Interchange

September 3, 2012

The new Director of the Food and Drug Administration’s (FDA) Office of Criminal
Investigations, John Roth, will be the luncheon speaker at the Partnership for Safe Medicines 2012 Interchange on September 28.

Roth joins the esteemed panel of Interchange speakers that includes keynote speaker Dr. Margaret Hamburg, Commissioner of the FDA, and panelists Gerald Heddell, Director of Inspection, Enforcement and Standards of the UK’s MHRA, and James Dinkins, Executive Associate Director, ICE’s Homeland Security Investigations.

Counterfeit Med Maker Dupes Patients With Internet Sales

August 29, 2012

A key member of a criminal drug gang that sold vast quantities of counterfeit drugs in the United States has been convicted, but his fugitive boss is who the Feds are really after.

A Puerto Rican man, Francis Ortiz Gonzalez has been convicted of conspiracy and seven counts of trafficking in counterfeit pharmaceuticals after a 6 six-day trial in Los Angeles. The trial followed a grand jury indictment from June 2009. Ortiz Gonzalez is set for sentencing on November 8th of this year, announced U.S. Immigration and Customs Enforcement (ICE).

Safe Medicines in China

August 28, 2012

August 2012 found The Partnership For Safe Medicine’s Executive Director Scott LaGanga meeting with Chinese government and business authorities in Beijing to discuss counterfeit medications.

The timing of the visit coincided with a government seizure of $180 million worth of counterfeit medications said LaGanga, noting that there is still much to be done to curb counterfeit drug production in China. “While a critical development, our work is only getting started and it will take the public-private partnership of government, industry, stakeholders and individual patients before we can make a dent in this issue,” wrote LaGanga in a blog post.

Gang Members Caught Selling Expired Cancer Medication; Thief Steals Cancer Meds to Sell into Gray Market

August 27, 2012

In Russia two gang members were arrested for selling expired cancer medications to pharmacies and hospitals, repackaged as if authentic. Meanwhile a Miami pharmacy technician stole fragile, refrigerated cancer medications in order to re-sell them.

In July 2012, Russian police arrested two counterfeit drug gang members for allegedly selling $15.4 million of counterfeit cancer medications.

7 Most Common Counterfeit Drugs

August 23, 2012

Melanie Haiken, writing for the MSN Wellness Blog, highlights the seven most likely drug counterfeits that US consumers could end up purchasing.

Counterfeit drugs are a scary threat to US consumers, writes Melanie Haiken in her article, 7 Scariest Counterfeit Drugs. You might think you are taking a pain reliever or lifestyle drug for weight loss or erectile dysfunction (ED) but instead you end up with any number of hidden poisons such as road paint, antifreeze, or an undeclared and unapproved medication like Sibutramine.

FDA Receives Reports of Fatalities Associated With Undeclared Ingredients

August 22, 2012

The U.S. Food and Drug Administration has issued an updated alert that Reumofan Plus and Reumofan Plus Premium contain undeclared prescription drug ingredients that have impacted public safety.

The agency announced it has received reports of “fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome,” in the two months since initially announcing the recall on the product in June.

As US Citizens Bring Resistant Malaria Strains Home, A Third of All Malaria Drugs Tested are Fake

August 16, 2012

Malaria is a major concern for public health officials throughout much of the world. Now a new report indicate US citizens returning from Africa are coming home with drug-resistant malaria, while The Lancet tells us up to one third of all malaria treatments are counterfeit.

News from Alertnet reports that US travelers returning from visits to sub-Saharan Africa are bringing home artemisinin-resistant malaria. Though no indication of large-scale malaria drug resistance has yet appeared on the African continent, it is a worrying trend that may presage full-scale drug resistance in African malarial strains.

USAID: Fighting Counterfeit Malaria Drugs Worldwide

August 13, 2012

Drug resistance as a result of the proliferation of counterfeit/low dose treatments is a growing problem in the fight against malaria. USAID is leading the charge to combat counterfeit malaria treatments in the places where malaria drug resistance is developing.

Drug counterfeiters, exploiting a captive audience in malaria sufferers, have helped create artemisinin-resistant malaria strains along the Thai/Cambodia and Thai/Myanmar borders. Counterfeit versions of malaria drugs have proliferated along the war-torn borders in Southeast Asia, and are also showing up in several African nations.

Overseas Counterfeit Drug Supplier Pleads Guilty to Federal Charges

August 10, 2012

Robin Han, a citizen of New Zealand, faces up to 30 years in prison and possible $6 million fine after pleading guilty to counterfeit drug charges last month.

US attorneys from the Central District of California have successfully prosecuted Han on charges he was a large scale trafficker of counterfeit drugs in the United States. His indictment was originally filed in 2007, but he was a fugitive from justice until March 29th of this year, when he was taken into custody at San Francisco International airport, reports U.S. Immigration and Customs Enforcement.

Han became a target of the federal probe in 2006, after US Customs and Border Protection officers intercepted a parcel containing counterfeit versions of erectile dysfunction medication. Subsequent investigation traced the shipment to Robin Han.

Chinese Government Detains Close to 2,000 on Counterfeit Drug Charges

August 8, 2012

Chinese officials announced the arrest of almost 2,000 people in a counterfeit drug ring operating in China. Authorities there said the drugs discovered were responsible for causing serious ailments, such as liver & kidney damage, and heart failure.

According the Reuters, suspects in the case were advertising the sale of their drugs online, in newspapers, and even on television.  More than 1,000 manufacturing facilities for counterfeit medicines were destroyed, and more than $180 million worth of counterfeit drugs.  

FDA Commissioner Margaret Hamburg Keynote Speaker at 2012 Interchange

August 6, 2012

Just announced! Dr. Margaret Hamburg, FDA Commissioner will be the keynote speaker at the 2012 Interchange, September 28th in Washington DC!

We’ve just received official confirmation that Margaret Hamburg, Commissioner of the United States Food and Drug Administration, will give the keynote speech at the  2012 Partnership for Safe Medicines Interchange. We’re very honored to have Commissioner Hamburg speak at the Interchange, and look forward to hearing her offer her expertise on the subject of counterfeit drug crime.

Dr. Hamburg is the 21st commissioner of the Food and Drug Administration. She was confirmed in her post on May 18, 2009. She is only the second woman to be nominated for this position, having served previously as an Assistant Secretary at the US Department of Health and Human Services, and also as Commissioner of the New York City Department of Health.

Fake online drug sellers, gray market distributors, and counterfeit medicines in the U.S.’s safe, secure drug supply chain will be subjects discussed at the 2012 Interchange in Washington DC September 28th. Please join us!

This will be the second time Commissioner Hamburg has spoken at a Partnership for Safe Medicines Interchange. She first joined us in 2010, where she addressed the problem of counterfeit drugs, “The issue of counterfeit drugs is one of both domestic and international concern. It is shocking to realize that, in some parts of the world, somewhere between 30 and 50 percent of drugs to treat serious diseases are actually counterfeit.”

Since her appearance at the 2010 Interchange, the FDA has had to contend with an increasingly globalized drug marketplace. Her continued efforts as commissioner have been to seek greater penalties for drug counterfeiters, and also give the FDA more authority to deal with counterfeit drugs when they discover them.

We hope you will join Commissioner Hamburg, Deputy Director Heddell of the MHRA, Associate Director Dinkins of the ICE Homeland Security Investigations, along with many other experts from medicine, policy, law enforcement, and patient advocacy at our 2012 Interchange in Washington DC. Discounted early registration ends August 15th, so register today!

Arrest Warrant Issued for Convicted Canadian Online Pharmacy Operator

August 2, 2012

An arrest warrant has been issued by Judge Irma Gonzalez, in the U.S. District Court for the Southern District of California, in San Diego, for Canadian businessman Nathan Jacobson as a result of his failure to appear for sentencing in the vast Affpower fake online pharmacy case.

In 2007, Jacobson was one of 18 indicted on racketeering and related charges for allegedly operating an internet business that generated more than $126 million in gross revenues from the illegal sale of prescription medicines from customers across the U.S., reported the U.S. Department of Justice.  

WSJ Connects Counterfeit Avastin Incidents to Canadadrugs.com

July 30, 2012

In February of this year, the FDA notified 19 cancer doctors that a counterfeit version of the cancer drug Avastin had breached the U.S.’s closed, secure drug supply chain. Now 5 months later, investigations have allegedly connected the counterfeit cancer drug’s entry into the US with one of Canada’s biggest online pharmacy operations, Canadadrugs.com.

PSM Applauds Launch of the Center for Safe Internet Pharmacies

July 30, 2012

Partnership for Safe Medicines Executive Director Scott LaGanga released the following statement on the launch of the Center for Safe Internet Pharmacies (CSIP):

“Today, the Partnership for Safe Medicines is pleased to welcome another powerful ally in the fight against counterfeit drugs. It is our sincerest hope that the launch of the Center for Safe Internet Pharmacies will make it far more difficult for criminals to peddle dangerous and potentially lethal fake ‘medicines’ to unsuspecting victims.

Patient Safety Threatened by Counterfeit Medications

July 26, 2012

Patient safety is the concern of every doctor, nurse, and pharmacist working in medicine today, reminded Founder of Partnership of Safe Medicines India, Bejon Misra. Counterfeit drugs impact patient safety, particularly in places where the drug supply chain is compromised.

In 2011, when asked what safe medicines meant to him, he responded simply, “Saving millions of lives.

Flood of Counterfeit Drugs Confiscated by European Border Officials in 2011

July 26, 2012

A new report by the European Commission identified a 9-fold increase in counterfeit drug seizures in the EU since 2010. 

In 2011, counterfeit drug enforcement in the European Union broke up counterfeit drug rings in Spain and the United Kingdom, identified fake HIV medication in the market and convicted fake asthma inhaler distributors in the UK. The new Report on EU Customs Enforcement of Intellectual Property Rights: Results At the EU Border-2011, showed “a continuous upward trend” in counterfeit medication confiscations at the border since 2010.

Instructables (2nd week), Stanford, and UNC Charlotte get Pwned!

July 24, 2012

There is a certain amount of irony in this week’s collection of pwned websites hosting fake online pharmacies. While we are a little surprised that Instructables is still hosting a site selling Xanax, and perplexed that a Criminal Justice program at UNC Charlotte would be selling Cialis without a prescription, our biggest shock was seeing…

UNODC Report Highlights Lucrative Nature of Global Counterfeit Drug Trade

July 23, 2012

“What is the real reason criminals counterfeit drugs?” As Congressman Jim Matheson said at the 2011 Partnership for Safe Medicine’s Interchange “follow the money.”

A recent report by the United Nations Office on Drugs and Crime (UNODC) highlights why more counterfeit drug cases are appearing in news reports.  Organized crime makes billions each year off of drug counterfeiting, amongst their other activities.  The UNODC estimates global counterfeiting enterprises generate $250 billion (US) in annual profits.

New Zealand Citizen Pleads Guilty in US Counterfeit Drug Case

July 19, 2012

View larger map Robin Han, a citizen of New Zealand, faces up to 30 years in prison and possible $6 million fine after his guilty plea on counterfeit drug charges. US attorneys from the Central District of California prosecuted Han on charges he conducted a large scale counterfeit drug trafficking business in the United States.…

How Fake Drug Criminals Snare Consumers Online

July 17, 2012

How is technology advancing in counterfeit drug crime? Learn more at the 2012 Interchange where Timothy K. Mackey, MAS, the 2011-2012 Carl L. Alsberg, MD, Fellow for Safe Medicines will present his research,  “A Day in the Life of Illegal Online Drug Sellers.”

Counterfeit drug sellers and fake online pharmacies use sophisticated web search redirection, IP-hijacking, and search result flooding to manipulate Internet users to purchase from their online counterfeit drug sites.

SMS Verification A Growing Technique to Fight Counterfeit Drug Crime

July 17, 2012

In the global fight to combat counterfeit drug crime, simple SMS technology is leading the charge for patient safety. 

A simple and low-cost solution to drug verification problems for patients, SMS text verification empowers consumers to protect themselves from counterfeit drugs by sending a numeric code from their drug packaging from their phone for free verification.  We’ll be discussing this and other technological innovations in the counterfeit drug fight at the 2012 Interchange on September 28, 2012.

Online Pharmacies Implicated in Counterfeit Drug Case Spanning Europe

July 12, 2012

The MHRA has announced that three men have been sentenced to 89 weeks imprisonment for laundering $400,000 generated by a fake online pharmacy selling counterfeit medicines.

The men were prosecuted as part of a wider investigation.  From 2004 to 2009 they were laundering profits from a criminal online pharmacy website based in Cyprus.  Says the MHRA, “The business was run by a UK criminal who set up a number of illegal online pharmacy businesses selling counterfeit and powerful prescription-only medicines from outside of the UK.”

The MHRA has been on a tear of prosecutions against illegal online pharmacies and counterfeit medicine and medical device sellers.  In early 2012, the MHRA let FDA agents know they suspected counterfeit cancer medications were being passed into the U.S.  They also prosecuted UK-based counterfeit drug distributor Peter Gillespie in 2011, who was working closely with Kevin Xu, convicted in the US for manufacturing and distributing counterfeit medications in 2010.

MHRA Director of Inspection, Enforcement and Standards, Gerald Heddell, will be speaking at the 2012 Interchange on September 28.  The Interchange, at the National Press Club, in Washington, DC, is a full day conference of policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies discussing the safety, health, and legal issues of counterfeit medications. Learn about the most recent criminal cases involving the MHRA and others at the 2012 Interchange.

MHRA agents made test purchases of counterfeit medicines to establish a link to the criminal enterprise, and then financial investigators traced over $1.5 million in three years from the websites’ UK bank account to a bank account in Cyprus. 

The impact that online counterfeit drug sales have on patients’ health is real, remarked Nimo Ahmed, Acting Head of Enforcement at MHRA. 

“This case highlights the criminality of the people who continue to put profit before patient’s health. These illegal pharmacy websites selling medicines bought from illegitimate sources pose a real threat to people’s health because they simply don’t know what they are getting.”

However, not all internet pharmacies are specious.  Online pharmacies that have the Verified Internet Pharmacy Practice Seal (VIPPS) are safe sources for the convenience and cost savings of online shopping, without the risks of potential counterfeit medications.