U.S. Senate weighs FDA drug safety measures, fees
Last Updated: 2007-05-01 10:01:34 -0400 (Reuters Health)
By Lisa Richwine
WASHINGTON (Reuters) - The Senate started debating legislation Monday to give the Food and Drug Administration new powers to police side effects from prescription drugs after they reach the market.
The measure also would extend and increase for five years the fees paid by drug and medical device makers for reviews of new products.
Supporters said the bill would allow the FDA to respond quickly to complications such as the heart problems that led to Merck & Co Inc.'s 2004 recall of painkiller Vioxx. Officials were criticized as slow to respond in that case.
"The FDA should be the gold standard for safety, but its luster has been tarnished in recent years by failure to protect the American people from unsafe drugs," said Sen. Edward Kennedy, a Massachusetts Democrat who co-authored the bill.
The legislation establishes a "flexible but effective program for safety," Kennedy said.
The FDA would be allowed to create plans for managing risks of new drugs and fine companies that violate them. The risk management plans could include post-approval studies, additional warnings on drug labels or other steps.
The Bush administration and some Republican lawmakers have objected to the bill as being too burdensome and possibly slowing down approval of new medicines that can help patients.
Sen. Mike Enzi, a Wyoming Republican who co-wrote the bill, said it may instead encourage earlier access to new therapies. "We won't have to worry quite as much pre-approval because we will have tools after approval" to detect side effects, he said.
Both senators said the legislation could be amended in the coming days.
Kennedy said he was trying to address concerns about advertising limits in the bill "to make sure they are consistent with the Constitution." Republicans had tried to remove language in committee that would would allow the health secretary to ban consumer ads for individual drugs for two years.
The legislation would codify FDA and industry plans to extend and raise fees paid by drug and medical device makers to help speed reviews and partly fund safety checks.
It adds $30 million in drug industry fees beyond the deal reached by the FDA and drugmakers for safety activities.
The bill is expected to pass but then will need to be merged with similar legislation planned in the House.
Sen. Richard Durbin said in an interview he would try to add provisions to strengthen the government's oversight of the food supply following contamination of pet food and spinach.
Durbin, an Illinois Democrat, said he wanted to give officials more authority to recall food products and strengthen reporting requirements when problems occur, among other things.
