House passes FDA Revitalization Act, boosting agency’s enforcement powers

WASHINGTON The House of Representatives voted overwhelmingly Wednesday to significantly boost the Food and Drug Administration’s drug-safety enforcement powers and reauthorize the agency’s ability to collect user fees from drug manufacturers.

In a 405-7 vote, House members passed a revised version of the FDA Revitalization Act and sent it on to the Senate, which is expected to approve the measure as early as this week. The White House has signaled its approval of the bill, which would give new teeth to the FDA’s drug-safety oversight procedures and reauthorize the Prescription Drug User Fee Act.

Missing from the bill, as expected, is any provision for creating a clear approval pathway at the FDA for generic versions of bio-engineered drugs. But some lawmakers, including Democratic Rep. Henry Waxman of California and Rep. Frank Pallone, D-N.J., have pledged to pursue biogeneric legislation separately in the coming months.

The bill passed by the House renews the PDUFA program for five years; if passed by the Senate and signed into law by Pres. Bush, as expected, it will avert a shutdown of that program prior to the scheduled Sept. 30 expiration of PDUFA’s current mandate. The program, which must be renewed by Congress every five years, will pour a total of more than $440 million in user fees into the FDA’s operating budget from drug and medical device makers to help defray the costs of reviewing hundreds of new-drug applications.

More significantly, the legislation greatly expands the agency’s responsibility for long-term, post-approval drug outcomes and patient safety. To do so, it arms the FDA with new authority and additional funding to regulate advertising and drug labeling, and to establish a surveillance system to analyze data and track long-term drug use and safety among millions of patients.

According to a new survey from American University’s Center for Congressional and Presidential Studies, expanding the agency’s drug-oversight capabilities has strong support from the public. More than three-quarters of those surveyed say prescription drug safety is at least somewhat important to them in deciding their vote for the 2008 presidential election, according to the center, and nearly half of Americans, 47 percent, rate the FDA’s overall performance as only “fair” or “poor.”

“At a time when Congress is debating the FDA Revitalization Act to strengthen the safety of prescription medicines and overhaul the FDA, this survey validates that drug safety is a real concern for the American public,” said James Thurber, director of the study center. “The survey shows…there is a clear desire and expectation among participants for regulators to balance speed of approvals with their responsibility of reducing safety risks.”

Fully 64 percent of those polled by American University also declared the U.S. health care system “broken.”