Senate OKs FDA drug safety bill, sends to Bush
WASHINGTON (Reuters) - The U.S. Senate approved and sent to the White House on Thursday legislation giving the Food and Drug Administration new powers to police serious side effects from prescription drugs after they reach the market.
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The new FDA powers are a response to serious problems that emerged in patients who took Merck & Co Inc's withdrawn arthritis drug Vioxx and other medicines.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 also 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 October 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.
The pharmaceutical industry voiced support.
"The U.S. Congress has taken a crucial step to make our nation's drug safety system - which already is the best in the world - even better," said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America.
Lawmakers preserved a six-month period of market exclusivity for drugmakers that test how their products work in children.
The legislation does not include provisions favored by some lawmakers to set a legal path for FDA approval of generic versions of biotechnology medicines.
