US House drug safety bill has additional review

By Susan Heavey

WASHINGTON, March 19 (Reuters) - U.S. regulators would have to conduct an additional review of a prescription drug's risks seven years after approval under a bill introduced on Monday that expands on a Senate measure requiring evaluations for the first three years.

Rep. Henry Waxman, chairman of the U.S. House of Representatives Committee on Oversight and Government Reform, said his bill also increases minimum fines on drugmakers and would alert consumers to recently approved products with special packaging.

Side effects of prescription medicines, regulated by the Food and Drug Administration, have come under scrutiny following the 2004 withdrawal of Merck & Co Inc.'s (MRK.N: Quote, Profile, Research, Stock Buzz) arthritis drug Vioxx, after studies linked it to a greater risk of heart attack and stroke.

"We need only look to recent high-profile post-market safety problems, like Vioxx, to know that our drug safety system is in desperate need of some serious improvements," said Waxman, a California Democrat.

Congress is considering toughening the post-marketing monitoring of drugs as part of renewing a program that requires companies to help pay for FDA review of their products.

Waxman said his proposal, co-sponsored by Massachusetts Democrat Rep. Edward Markey, goes farther than a Senate proposal by Massachusetts Democrat Edward Kennedy and Wyoming Republican Michael Enzi.

"The Enzi- Kennedy bill is a significant step forward in addressing these concerns. Our legislation goes even further in giving FDA the full complement of tools it needs to protect our citizens from unsafe products," he said in a statement.

Both bills would require the FDA to review a drug's potential risks annually for the first three years after approval. But the House legislation calls for another review four years later to see if any new side effects have emerged.