Pharmaceutical Drug Bill Moves Forward
Following recent drug-safety scandals, including the 2004 Vioxx withdrawal, the U.S. House of Representatives has voted in favor of giving health officials more resources to do their job. The Prescription Drug User Fee Act (PDUFA) gives the U.S. Food and Drug Administration an additional $400 million in fees collected from the drug industry. The money is earmarked for drug safety oversight over the next five years, including increased "postmarketing" surveillance of drugs already on the market.
The Senate has already passed a similar bill. Both bills mandate the continuance, through 2012, of a program whereby drug companies pay fees to the FDA to offset agency expenditures on the review of new medicines. House and Senate committees must now work on a compromise bill acceptable to both bodies.
The bill, passed Wednesday in the House with a 403-16 vote, gives the FDA authority to require post-marketing safety studies, and it requires drug companies to provide timetables for completing these studies. The agency also reserves the right to mandate label changes to a drug or restrict its use or distribution, should problems arise. In addition, the bill reauthorizes a medical device industry user-fee program. That is expected to add extra cash to FDA coffers.
One item noticeably absent from the House bill: any provision that would allow U.S. consumers to buy cheaper drugs from abroad. The White House has said in the past that it would veto any bill containing such a clause.
