Policy/Enforcement News
Justice Department Dismantles Fake Online Pharmacy Conspiracies & Convicts 9
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.
[...]FDA Uses Portable Rapid Testing Devices to Insure Patient Safety
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.”
[...]UNODC Conference Highlights Fake Drugs Distributed by Organized Crime
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.”
[...]Recent Efforts by Chinese Government to Crackdown on Counterfeit Drugs Show Progress
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.
[...]UK’s Medicine Regulatory Agency Warns of Dangerous Ingredients in Herbal Remedies
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.
[...]Institute of Medicine Releases Report on Falsified and Substandard Drugs
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.”
US Counterfeit Drug Distributor Sentenced in Los Angeles
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.
[...]Canadian Internet Pharmacy Founder Gets 4 Years in Counterfeit Drugs Case
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.
[...]The Year in Review – Part 2 – Diversion, Black Market and Internet
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.
Doctor Pleads Guilty in Misbranded Cancer Drug Case
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.