Policy/Enforcement News
HIV/AIDS Black Market Sells Fraudulent Drugs to Unwitting Victims
Pharmacists in Brooklyn and Suffolk County have been charged with allegedly re-selling HIV and AIDS medications to patients that had been illegally obtained on the black market. The medications were mislabelled and potentially mishandled and expired. Attorney General Eric Schneiderman said, "The ringleaders of this complex scheme not only cheated the Medicaid program out of…
[...]USP Will Hold Workshop on Supply Chain Integrity May 22-23
The United States Pharmacopeial Convention (USP) is hosting a two day workshop on good distribution practices and supply chain integrity in Rockville, MD. The objectives of the workshop are To discuss the breadth of current issues, regulations and solutions. Obtain additional input for USP General Chapter <1083>. Identify opportunities for USP's role in supply chain…
[...]NABP Release Year End 2011 Data: Fake Pharmacies Proliferate, the Many Controlled by the Few
The National Association of Boards of Pharmacy has released year end data on safe online pharmacies showing the rise of the “affiliate network.”
While the number of legitimate online pharmacies safe for Americans remains at 4% of all, the growth of fake online pharmacies out of compliance with U.S. pharmacy laws and practice standards appears to be strongly linked to the spread of underlying source organizations called “affiliate networks” that proliferate the internet with copies of their websites.
The NABP has published a report, “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: January 2012” which identifies 8,456 so-called online pharmacies that are out of compliance with U.S. pharmacy laws and practice standards. Of those, 8,265 appear to be network affiliated, 98%.
The NABP staff identified websites that use the same phone number, physical address, domain name registrant, website design or web business name as those being part of a rogue affiliate network. A rogue affiliate network is a group of internet drug outlets operated by one organization, which are frequently operated outside of the U.S.
“The common perception in America is that a discount retailer out there on the internet can, because of lower costs of business elsewhere, provide medication at below U.S. market rates. What they don’t know is that the medications are all coming from the same counterfeiters in India and China, and that a giant conglomerate of organized crime runs these hundreds of millions of websites that advertise as if they were ‘mom and pop’ small pharmacies on the internet,” said Carmen Catizone, NABP’s Executive Director.
[...]Pills Containing Heavy Metal Toxins Found in Circulation in China
AFP has reported that Chinese authorities have detained 22 people accused of making drug capsules using chromium, a toxic metal that can cause kidney, liver, and blood cell damage. 13 Chinese manufactured medications have been removed from domestic circulation due to excessive chromium levels.
[...]How to Stay Safe as a Patient
Patients are growing concerned about reports of counterfeit drugs being provided by doctors. Patients can protect themselves by asking their physicians questions about the origins of medicines they receive in their doctor’s office.
Read more about what patients can do to stay safe.
[...]Criminal Gang Suspected in Fake Medicine Tablets Seizure
Two people were arrested in Northeastern England by Medicines and Healthcare products Regulatory Agency (MHRA). Several thousand fake medicine tablets have been seized estimated at £115,000. Counterfeit erectile dysfunction medication and unapproved anti-obesity medicines rimonabant and sibutramine were found, reports the MHRA. Spanish police and Europol, arrested six people and collected approximately 300,000 doses of…
[...]1/3rd of All Fake Online Pharmacies Get Domain Names From One Company
A new report by online pharmacy security company LegitScript claims that 33% of the world’s non-spam Internet fake pharmacies rely on one domain name registrar. Their new research report shows their willingness to “serve as a safe haven for criminal drug-related activity.”
[...]Counterfeit Chemo Contained Acetone – 36 Vials Still Missing
Swiss drug maker, Roche, released details of the contents of the counterfeit Avastin found in 19 U.S. cancer clinics.
[...]MHRA – FDA Cooperation Rousts Counterfeit Cancer Drugs
Cooperation between the U.K.’s Medicines and Healthcare Products Regulatory Agency and the USFDA brought the counterfeit Avastin distribution to light in the U.S. when MHRA officials let U.S. Food and Drug Administration agents know in December that they suspected the problem.
MHRA officials notified U.S. agents and Roche, which led Roche to test and confirm the vital life-saving medication as counterfeit last week, reported Reuters.
“As tragic as this incident is, it is to the credit of the manufacturer and law enforcement that they’ve been able to track down the source of the supplier of the counterfeit medication and contact their other customers. In many countries counterfeits make their way to patients without anyone ever being held accountable,” said Partnership for Safe Medicine’s board member Tom Kubic, President and CEO of the Pharmaceutical Security Institute.
Connie Jung, of the FDA’s Office of Drug Security, said it was possible that more than the 19 originally notified practices could be involved and warned that if a price appears to be too good to be true, it probably is.
Sources say that Montana Health Care Solutions sold the vials for 25% less than the expected cost, reports ABC World News.
Patients are beginning to be aware of the counterfeits, with growing outrage.
Said cancer patient Diane Barraza to ABC World News, “To sit in the chemo chair and watch that stuff drop into my veins,” who lives in Fullerton, Calif., with her 6-year-old daughter. “It’s all I’ve got. And it might just be water?”
AstraZeneca Backs Counterfeit Drug Penalty Legislation in US Congress
On January 19, 2012, AstraZeneca sent members of Congress a letter supporting legislation to increase penalties for counterfeit prescription drug crime.
The letters were sent to Senator Patrick Leahy (D-VT), Senator Chuck Grassley (R-IA), Representative Linda Sanchez (D-CA), and Representative Patrick Meehan (R-PA), bill sponsors along with Senator Michael Bennet (D-CO) and Senator Richard Blumenthal (D-CT.).
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