Policy/Enforcement News

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.

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.

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.”

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.

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. 

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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.

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