FDA Seeks Authority To Approve Generic Versions Of Biotechnology Drugs

Armen Hareyan's picture

FDA officials on Monday said that the agency willseek authority from Congress to approve generic versions of biotechnologydrugs, CQ HealthBeat reports (Carey, CQ HealthBeat,2/4). FDA Chief Operating Officer John Dyer said that the agency is working onlanguage for the legislative proposal. An aide said that FDA notified the House Energy and Commerce Committee that it would submit a proposal butdid not disclose a timeline (Edney, CongressDaily, 2/5).

FDA officials said the measure would "include necessary provisions toensure the safety and effectiveness of these biologic products forpatients" and call for a "predictable and public guidance process forlicensing follow-on protein products." In addition, the proposal woulddescribe what types of data the agency would require for generic biotech drugapplications and would specify what information would be required on productlabels. The draft proposal also would include "adequate intellectualproperty protections to preserve continued robust research into new andinnovative lifesaving medications," officials said.


Makers of brand-name biotech drugs have requested 14 years of marketexclusivity (CQ HealthBeat, 2/4). The Senate Health, Education, Labor and Pensions Committee last summer approved legislationthat 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 havestalled in Congress (CQ HealthBeat, 2/4). CongressDailyreports that if Congress "waits another year, chances are biologic drugcompanies could see exclusivity more akin to traditional drug makers, which aregranted three to five years of sales without generic competition."

President Bush on Monday in his fiscal year 2009 budget plan proposed a userfee program that would fund FDA regulation of generic biotech drugs (CongressDaily,2/5). The program would charge generic biotech drug makers a fee to reviewtheir applications for regulatory approval (CQ HealthBeat, 2/4).

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