Posts Tagged ‘drug safety’
Dallas Area Hospital Among Hundreds Receiving FDA Warning About Unapproved Versions of Botox
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.
[...]Florida Man Gets 10 Years For Complex Drug Diversion Scheme
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.
[...]Seniors Can Learn to Save Money Safely When Shopping for Medicine Online
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.
[...]Doing Our Part to Protect Patients
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.
Who is the Criminal Mastermind Behind the Counterfeit Cancer Drug Scare?
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.
China Cracks Down on Counterfeit Drugs With the Help of the FDA
The internet is a wild west of unregulated pharmaceutical websites, but Chinese and US cooperation are working together to make the Internet safer for consumers.
China Daily reports that US Food and Drug Administration agents working in China collaborated with the China Food and Drug Administration to shutter 18 Chinese-language websites illegally offering counterfeit drugs and health food for sale in the United States.
[...]Safe Medicines in China
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.
[...]FDA Receives Reports of Fatalities Associated With Undeclared Ingredients
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.
[...]Overseas Counterfeit Drug Supplier Pleads Guilty to Federal Charges
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.
[...]FDA Commissioner Margaret Hamburg Keynote Speaker at 2012 Interchange
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!
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