Drug safety legislation clears U.S. House panel

By Lisa Richwine

WASHINGTON (Reuters) - A U.S. House of Representatives committee voted on Thursday to give the Food and Drug Administration more power to monitor the side effects of medicines after they reach the market.

The FDA would have the authority to require post-approval studies of new medicines or order additional warnings under legislation that cleared the House Energy and Commerce Committee in a 39-0 vote.

Lawmakers lowered the potential fines for failure to comply with FDA directives to $50 million from $100 million after Republicans complained they were too high.

The legislation also would authorize fines of $250,000 for running a false or misleading consumer-directed advertisement for a prescription drug.

The new powers for the FDA were included among several measures meant to improve the government's drug safety oversight, increase transparency of company clinical trials and raise the fees that manufacturers pay to help speed reviews of new medicines and medical devices.

The legislation is a response to complaints about the FDA's handling of serious side effects that appeared after drugs hit the market. The agency was criticized as slow to act on signs of problems with Merck & Co. Inc.'s arthritis pill Vioxx, which the company withdrew in 2004, and other medicines.

"We have been alarmed by recent occurrences at FDA regarding the safety of prescription drugs," said Committee Chairman John Dingell, a Michigan Democrat.

Rep. Joe Barton of Texas, the panel's leading Republican, called the drug safety provisions "the product of true bipartisanship and true compromise" that properly balanced concerns about risks and access to new therapies.

The full House is expected to consider the measure in July. Lawmakers then must reconcile the House legislation with a similar version that passed the Senate in May, and send the measure to President George W. Bush to sign into law.

The Senate version differs from the House plan. For example, it caps fines at $2 million and includes lower drugmaker fees.

Pharmaceutical companies and the FDA had proposed $393 million in drugmaker fees for each of the next five years to help speed product reviews. Under the House bill, companies would pay an extra $225 million over five years to help fund post-approval drug safety monitoring.

The committee agreed to lower the fees if Congress provides enough taxpayer money to support FDA activities.

The panel also passed measures to encourage development of medical devices for children and extend patent incentives for pediatric testing of medicines. Other bills would limit conflicts of interest on FDA advisory panels and require disclosure of companies' clinical trials.

The measures were considered as nine separate bills and then combined as one that was sent to the full House.

The Pharmaceutical Research and Manufacturers of America, an industry group known as PhRMA, said the committee had adopted "a constructive, balanced approach."

"Overall, the legislation passed by the committee will preserve -- and even strengthen -- the FDA's ability to do its job. Patients will continue to have timely access to innovative therapies, and they can be assured that the medicines they receive are reviewed under the most rigorous standards in the world today," PhRMA President Billy Tuazin said in a statement.