FDA To Seek Authority To Approve Generic Versions Of Biotechnology Drugs
FDA officials said the measure would "include necessary provisions to ensure the safety and effectiveness of these biologic products for patients" and call for a "predictable and public guidance process for licensing follow-on protein products." In addition, the proposal would describe what types of data the agency would require for generic biotech drug applications and would specify what information would be required on product labels. The draft proposal also would include "adequate intellectual property protections to preserve continued robust research into new and innovative lifesaving medications," officials said.
Makers of brand-name biotech drugs have requested 14 years of market exclusivity (CQ HealthBeat, 2/4). The Senate Health, Education, Labor and Pensions Committee last summer approved legislation that would have given brand-name biotech drug makers 12 years of protection, while Democrats were pushing for as few as seven years (CongressDaily, 2/5). However, past efforts to pass generic biotech drug legislation have stalled in Congress (CQ HealthBeat, 2/4). CongressDaily reports that if Congress "waits another year, chances are biologic drug companies could see exclusivity more akin to traditional drug makers, which are granted three to five years of sales without generic competition."
President Bush on Monday in his fiscal year 2009 budget plan proposed a user fee program that would fund FDA regulation of generic biotech drugs (CongressDaily, 2/5). The program would charge generic biotech drug makers a fee to review their applications for regulatory approval (CQ HealthBeat, 2/4).
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FDA de a cãuta autoritatea de a aproba generic versiuni de droguri Biotehnologie - FDA To Seek Authority To Approve Generic Versions Of Biotechnology Drugs - articole medicale engleza - startsanatate