Regulatory Roundup: Woodcock Discusses Pain Management and Drug Safety in NEJM; and More.

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, new European Generic medicines Association president begins term.

Regulatory Roundup

In a Nov. 26, 2009 New England Journal of Medicine article, US Food and Drug Administration Commissioner Janet Woodcock published, “A Difficult Balance–Pain Management, Drug Safety, and the FDA.” The commissioner discusses the agency’s efforts to balance providing access to pain medication for those who need it and managing the risks posed by various analgesics such as FDA’s recent actions with acetaminophen, propoxyphene, and Oxycontin. The actions, according to an FDA release, are part of the Safe Use Initiative, aimed at reducing the likelihood of preventable harm from medication use.


Didier Barret began his two-year term as the new president of the European Generic medicines Association (EGA) on Nov. 18, 2009. Barret is president of Europe, Middle East, and Africa for Mylan and succeeds Eric Gorka of Sandoz. “If all conditions are met to allow generic and biosimilar medicines timely and fair access to the markets as put forward by the EC recommendations following the pharmaceutical sector inquiry, the potential is there to reshape the European healthcare landscape, be it in terms of patient access to medicines or savings for the healthcare systems,” said Barret in his acceptance speech, according to an EGA release. He noted that the priority for his presidency will be “creating the conditions for a sustainable and competitive generics industry in the European market” with a focus on: Promoting sustainable generic medicines pricing systems; granting automatic pricing and reimbursement status for generic medicines upon market authorisation while avoiding post-patent delays; enforcing clear criteria for innovation, defined as synonymous with added relative therapeutic efficacy or safety, to eliminate evergreening practices; fostering mechanisms to promote generics prescribing by physicians and generics dispensing by pharmacists; creating the appropriate EU regulatory environment for generic and biosimilar medicines; and continuing cooperation with the European Patent Office in raising the bar on patent applications.