US drug, device companies eye more FDA fees

By Susan Heavey

NEW YORK (Reuters) - Makers of brand name drugs and devices sold in the United States are anticipating higher industry fees to take effect next year when lawmakers look to renew laws that help fund the Food and Drug Administration.

At the same time, government and industry experts have said the bill could become a vehicle to tack on additional measures to address drug safety and advertising, among other issues.

"They're going to go up," Merck & Co. Inc. (MRK.N: Quote, Profile, Research, Stock Buzz) Chief Executive Officer Richard Clark said about the fees this week at the Reuters Health Summit in New York.

The payments, set to expire next September, were first established by Congress in 1992 and have been renewed twice. Consumer groups criticize the fees, but lawmakers from both parties have voiced support and are expected to extend them again.

Companies initially agreed to the fees to help pay for more agency staff to speed up reviews of their experimental products. Critics have said the fees pressure the FDA to answer to company executives rather than put patients first.

Industry lobbying groups are in private discussions with the FDA over what the new fees should be before later presenting a plan to lawmakers. The negotiations are expected to be completed by the end of this year, Clark said.

The FDA has complained that the fees do not cover the increasing number of meetings officials have with companies during the development process. The FDA could not immediately comment on the fees or the negotiations.

Additional industry fees could supplement government funding for new measures to increase post-approval drug safety surveillance, said Merck's Clark, whose company's withdrawal of its Vioxx painkiller in 2004 sparked a flurry of debate over the FDA's handling of potential side effects.  Continued...