The Pharmaceutical Medicine Year that Was
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Pharm Med 2010; 24 (6): 339-342 1178-2595/10/0006-0339/$49.95/0
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The Pharmaceutical Medicine Year that Was A View from San Diego, California, at the End of 2010 Anthony W. Fox Consulting Editor, Pharmaceutical Medicine
For observers of the ‘regulatory sciences’, it has been another fascinating year.[1] Serious efforts at improving drug safety have got underway and the European Medicines Agency (EMA), through its Committee for Medicinal Products for Human Use (CHMP), has approved a biosimilar epoetin, although the subject of biosimilars remains under review at the US FDA (the next hearings are 2–3 November 2010).1 Less positive events include the rosiglitazone fiasco reaching the stage of licence withdrawal in Europe and severe restrictions on its distribution in the US. Meanwhile, the FDA-mandated withdrawal of a tiny product (which doubtless seemed to be an easy target for the politically-attractive ‘seen to be doing something’) promptly backfired. Stem cell research has also come under legal threat in the US and, finally, the extreme financial constraints on small innovator companies seem to have eased slightly. January began with an announcement by Principal Deputy Commissioner Joshua Sharfstein that the FDA would release its transparency proposals in February. The draft document for public comment finally appeared in May.[5] A three-phase approach has been proposed. The first was completed in January and provides the public with ‘FDA Basics’, a list of 126 frequently asked questions and their answers. The second phase is entitled ‘public disclosure’ and contains 21 separate suggestions that would allow the FDA to publish more of the data in its possession. These include providing (often immediately) to the general public: adverse event reports, status of enforcement actions, industrial inspection reports, investigational new drug (IND) issuance and their contents, details of new drug applications (NDAs) under review, details of ‘not approvable’ letters, item data that would not usually appear in a post-approval Summary Basis of Approval, and untitled letters to sponsors. It
would clearly require large changes to the regulations and, possibly, the Statutes themselves. The big concern is that journalists and plaintiffs’ attorneys will exploit this mass of unanalysed technical information in their usual uneducated and self-serving manners, respectively. It was also in January that the US Office of Management and Budget Director, Dr Peter R. Orszag, in collaboration with Congressman Henry Waxman, repeated the call for new approvals of biological drugs to benefit from only a 7-year exclusivity period before biosimilars (the biological equivalent of generic drugs) would be permitted. This contrasted with the suggestion by House Speaker Nancy Pelosi and Senate Majority Leader Harry Reid, together with another eight senators and 45 congressmen, that it should be 12 years. At no time in this debate has there been any recognition of the long development times and e
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