UPDATE 1-US Senate OKs FDA drug safety bill, sends to Bush
(Adds FDA comment)
WASHINGTON, Sept 20 (Reuters) - The U.S. Food and Drug Administration will gain new power to police serious side effects from prescription drugs already on the market under legislation approved on Thursday by the Senate and sent to the White House.
The measure, prompted in part by a string of drug safety controversies, also extends industry fees that help fund FDA product reviews and authorizes more money for post-approval monitoring of medicines.
President George W. Bush is expected to sign it into law.
On Wednesday, the House of Representatives voted 405-7 in favor of the sweeping bill, a compromise reached after months of negotiations. The Senate passed it by unanimous consent.
The legislation allows the FDA to require new warnings on approved prescription drugs, order the completion of post-approval safety studies or limit a product's distribution because of side effect concerns. Companies that do not comply could be fined up to $10 million.
"Today's action is a major victory for patients, medical progress, and every family that relies on the FDA for safe food and medicine," said Sen. Edward Kennedy, a Massachusetts Democrat and chairman of the Senate Health, Education, Labor and Pensions Committee.
The new FDA powers are a response to serious problems that emerged in patients who took Merck & Co Inc's (MRK.N) withdrawn arthritis drug Vioxx and other medicines. Critics said the FDA was too slow to respond to signs linking Vioxx to heart attacks and strokes, as well as risks associated with antidepressants and other drugs.
Lawmakers decided the agency needed clear authority to compel drugmakers to add new warnings or finish post-approval studies that might detect risks not seen in pre-market trials.
The legislation extends for five years and increases the fees that drug and medical device makers pay to help fund product reviews. Pharmaceutical company payments will total nearly $393 million in fiscal 2008, which begins Oct. 1, about $87 million more than the current level.
Drugmakers will pay an additional $225 million over five years to help fund post-approval safety monitoring. The amount could go down if Congress provides money for the same purpose.
For the first time, drug and device makers must post basic results for clinical trials of approved products in a public database.
The bill also includes an FDA and industry agreement for companies to pay fees to fund agency reviews of television commercials that are submitted voluntarily.
FDA Commissioner Andrew von Eschenbach said he was pleased Congress passed the measure and renewed programs "vitally important to the agency and its continued ability to protect and promote the public health."
"We look forward to working towards implementation of this legislation," von Eschenbach said in a statement. Continued...
