House acts to prevent FDA layoff notices
Racing to avoid the embarrassing prospect of layoffs at the Food and Drug Administration, the House on Wednesday overwhelmingly approved a bill to boost funding for the agency and revamp the nation’s troubled drug safety system.
Unless the Senate approves the legislation by Friday, the agency will have to notify about 2,000 employees, many of them doctors and scientists, that they could be out of work.
“We are hoping it will pass easily in the Senate,” said Rep. Frank Pallone Jr. (D-N.J.), a key author of the House bill, a bipartisan compromise that was being tweaked until shortly before it was rushed to the floor.
Senate staffers were poring over the bill’s 400-page text, and leaders were hoping to be able to pass it by voice vote. But some Senate Republicans raised concerns. “We’re getting a bill that has been mashed together at the last minute,” said a GOP aide involved in negotiations with the House. “It’s very worrisome.”
The legislation, which the House passed 405 to 7, would renew and increase fees drug and medical device makers pay that fund much of the FDA’s analysis of drugs submitted for approval. It also would overhaul the drug safety system so problems that emerge after medications have been approved for use can be spotted faster.
“No drug is completely safe,” said Rep. Joe L. Barton (R-Texas), another leading House author. The bill strives to “ensure that the balance between benefit and risk remains in equilibrium,” he said.
The bill would set up a computerized surveillance system to try to spot problems with medications that have recently come on the market. While the FDA’s current surveillance network relies on anecdotal reports from drug companies and doctors, the new system would scan insurance and pharmacy claims data to try to identify possible patterns of problems.
When signals of a safety problem arise, the agency would have new authority to issue warnings sooner and to order drug companies to undertake in-depth studies.
The bill would expand the current registry of clinical trials and create a publicly accessible database of clinical trial results that could be used by safety researchers, doctors and patients.
Drug company advertisements -- including the consumer-oriented commercials that are a staple of television programming -- would get closer FDA review, and the ads would have to include instructions on reporting side effects.
The legislation would also require the FDA to reduce its reliance on outside advisors who have financial ties to the pharmaceutical industry.
With the exception of Rep. Maxine Waters (D-Los Angeles), who did not vote, all members of the California delegation voted for the bill.
“This is not a perfect bill, and compromises were made to assure its passage,” said Sen. Edward M. Kennedy (D-Mass.), an author of the Senate version. “But after so many recent instances in which Americans have been harmed by unsafe prescription drugs . . . America cannot afford inaction on this important measure.”