Lawmakers Seek To Boost Rx Drug Safety With User Fee Bill

The House later this month is expected to debate reauthorization of the Prescription Drug User Fee Act, which since its passage in 1992 has been a "huge success" in speeding FDA approval times for new prescription drugs, the Washington Post reports.

The Senate recently approved a bill (S 1082) that includes a five-year reauthorization of PDUFA.

The Post reports that user fees have "dramatically changed the [U.S.] from a country where new drugs came late to one where they come early." About 50% of new prescription drugs now first become available in the U.S., up from about 8% in the decade before PDUFA was passed.

Moreover, the average FDA approval time for standard drugs fell to 14 months from 22 months between 1993 and 2003. PDUFA also has resulted in the number of FDA workers who review new drugs nearly doubling to 2,500 in 2004 from about 1,300 in 1992.

However, many experts argue that PDUFA needs to be reformed by significantly increasing funding for the surveillance of drugs after they have reached the market.

Richard Platt, a researcher at Brigham and Women's Hospital in Boston, and other experts say that large databases maintained by CMS and private insurers can be analyzed by computer programs to identify potential safety concerns with drugs on the market more quickly than the current method of risk identification, in which government regulators wait to receive reports about observed risks.

Other experts argue that FDA's reliance on funding from the pharmaceutical industry -- the agency has requested $393 million in user fees for 2008, $87 million more than this year -- has the potential to compromise the agency's ability to monitor drug safety.

Jerry Avorn of Harvard Medical School said that FDA's dependence on industry funding might corrupt the agency in subtle ways, adding that reauthorization legislation "is our last chance to get it right before five more years go by." Despite such concerns, "it seems likely that heavy reliance on user fees ... will continue to be a key feature of pharmaceutical regulation," the Post reports (Brown, Washington Post, 7/5).