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Thursday, April 19, 2007

PDUFA Reauthorization Moving through Senate

Yesterday, the Senate Health, Education, Labor and Pensions Committee voted favorably to reauthorize the Prescription Drug User Fee Act (PDUFA). PDUFA allows FDA to collect money from the drug industry in order to pay for safety tests of new drugs. While this may sound like a good way for the government to raise funds, the money comes with strings attached. The drug industry, to some extent, dictates the timetable for drug approval.

PDUFA reauthorization is one part of the Food and Drug Administration Revitalization Act (S. 1082). Four Republicans and one independent joined all committee Democrats in voting to report the bill to the full Senate. If enacted in its current form, the legislation would:

• Reauthorize PDUFA for another five years. FDA will be able to collect more user fees from the drug industry, per the agency's recommendation.
• Allow FDA to review TV ads for new drugs (you know, the commercials that list a variety of unpleasant side effects). Some Republicans have raised First Amendment concerns in regard to this provision.
• Strengthen FDA's ability to monitor drug safety after the drugs reach the market.
• Reauthorize MDUFMA, a law similar to PDUFA but for medical devices instead of drugs.
• Create special provisions for the study of pediatric drugs and medical devices.
• Place medical marijuana under the regulatory purview of FDA. Sen. Tom Coburn (R-OK) added this provision as an amendment.

The bill will now move to the Senate floor. Bill cosponsor Ted Kennedy has also vowed the final bill will include language to allow FDA to approve generic drugs, a provision the drug industry adamantly opposes. The House is still developing its PDUFA reauthorization bill.