FDA Needs Active Safety Surveillance, More Authority, Consumers Union Says

The FDA needs a more active drug safety surveillance system and more authority over drugmakers when it finds serious adverse events, according to a leading consumer watchdog group.

Currently, the FDA system relies mostly on mining health databases for adverse event reports from drugs on the market. While they are a good tools, they should only be one part of a surveillance system that actively tracks products throughout their life cycles, Consumer Union Senior Policy Analyst Bill Vaughan said.

When the agency does find adverse events with a drug, it has limited power over companies and cannot require labeling changes or more clinical trials. The FDA can only require a company to remove a drug from the market if safety questions arise, and the agency rarely uses this power, Vaughan added.

Legislation in the House and Senate would give the agency increased authority over drug companies and require companies to make clinical trial data publicly available. The "Enhancing Drug Safety Act of 2007," S.484 and H.R.1561, would give the FDA more tools to find and track adverse events throughout a product's life cycle, according to House sponsor Rep. Henry Waxman (D-Calif.).

In addition, the bills would allow the agency to impose monetary fines on companies that did not comply with regulations. The house version has a minimum fine of $50,000, while the Senate bill sets the minimum at $15,000. Consumers Union supports both of these bills, Vaughan said.