CONSUMERS UNION LOBBIES TO STRENGTHEN DRUG SAFETY BILL

Consumers Union is calling for changes to strengthen S.484, the "Enhancing Drug Safety and Innovation Act," because the current version will not make a major difference in the FDA's drug safety processes, the organization said.

If the bill were already in place, it would not have prevented Vioxx and other harmful products from reaching the market, speakers at a briefing on Capitol Hill said. The bill, sponsored by Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.), attempts to improve transparency in the drug safety review process.

The bill should require that results of all Phase II, III and IV clinical trials be made public within a year of trial completion, Consumers Union said. Currently the bill exempts some Phase II trials.

The bill should also add to the ways the FDA can regulate drug companies, such as a three-year ban on direct-to-consumer advertisements for drugs with safety concerns, the group added. It also recommended higher monetary fines for companies that do not comply with FDA safety regulations.

Overall, the FDA needs to regain its scientific culture and be accountable to constituents other than the drug industry, speakers said. The agency's current leaders see the FDA as a "drug developing agency," not a regulatory agency, former FDA employee David Ross said. Previously, Ross testified at a House subcommittee hearing investigating the FDA's drug approval process, focusing on the agency's approval of Ketek.

"We need new drugs but we do not need them to be reviewed recklessly," Ross said. The Prescription Drug User Fee Act allows drug companies to influence the agency, making it speed through reviews, he added. Harvard Medical School professor Jerry Avorn agreed, saying the agency is "the handmaiden of the drug industry."

( http://www.fdanews.com/did/6_50/ )