Showing posts with label Edward c. Lawrence. Show all posts
Showing posts with label Edward c. Lawrence. Show all posts

Monday, February 11, 2013

Despite new law, counterfeit medicines continue to penetrate the U.S. market


Edward C. Lawrence
While some progress has been made in addressing the inflow of counterfeit drugs into the U.S. with the FDA Safety and Innovation Act (FDASIA) signed into law on July 9, 2012, there is still much more to be done. The recent news of fake anti-cancer drug Avastin has again put the issue of drug safety under the media spotlight. The latest estimates of counterfeit pharmaceuticals in the global market place the value between $75 billion and $200 billion a year. To put this issue in perspective, the World Health Organization (WHO) estimates that 100,000 Africans die each year as the result of fake anti-malarial drugs, which make up an estimated 15 to 30% of the market. Furthermore, this black market reduces government revenues by 2.5 to 5%. Even though high safety and regulatory standards in the U.S. have traditionally kept fake drugs below 1% of the total national pharmaceutical market, the percentage is expected to rise as improving technological sophistication allows counterfeiters to exploit potential shortcomings in the supply chain.
The recent Avastin case is not the first time a complex medication has been counterfeited. In 2008, Chinese subcontractors for Baxter International’s injectable blood-thinner heparin substituted the active ingredient with a cheaper, toxic substance. 

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Questionable Expansion of State Pharmacy Board Regulatory


02/03/13
In an excellent piece published in the BNA Pharmaceutical Law and Industry Report, “Confounded in Compounding Apothecaries: The Critical Need for Confining State Pharmacy Boards to Self-Regulation,” William G. Schiffbauer takes a close look at state pharmacy boards and the conflicts of interest and other problems that have arisen in connection with recent expansions of their activities.
He finds that pharmacy boards, mostly made up of pharmacists, have strayed from their core mission of “self-regulating” pharmacists – that is maintaining the competence of professional pharmacists and identifying and disciplining problem pharmacists. An example of inappropriate pharmacy board regulatory activity is the regulation of compounding pharmacies such as the New England Compounding Center whose negligence is reported to have caused 44 deaths and sickened 678 people in 19 states. Schiffbauer notes that it took 25 deaths and 344 injuries to “move” the Massachusetts Board of Pharmacy to adopt emergency regulations – long after the facts were known and after similar tragedies had already occurred. According to Schiffbauer, compounding pharmacies act more as pharmaceutical manufacturers than as local pharmacists, and pharmacy boards have neither the resources nor the competence to regulate pharmaceutical manufacturing processes.
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