Kennedy circulates options on strengthening FDA oversight

The office of Senate Health, Education, Labor and Pensions Committee Chairman Edward Kennedy, D-Mass., Monday circulated a list of options for strengthening drug and device safety that might be included in legislation his panel is eyeing to improve FDA oversight.

The options include charging industry registration fees to fund more FDA inspections of drug and device plants and requiring the agency to inspect foreign drug firms as often as domestic ones.

Those and many of the other provisions are similar to ones proposed by House Energy and Commerce Committee Chairman John Dingell, D-Mich., but unlike Dingell's, one of the Senate options includes giving FDA the power to base its inspections on risk.

At a House hearing on the Dingell proposal last week, Janet Woodcock, FDA's drug center director, stressed the need for the agency to spend its resources as it sees most fit. Some consumer advocates are wary of a risk-based approach, but Woodcock also admitted companies should operate under the impression they will be inspected on a regular basis.

FDA inspects domestic drug companies once about every three years and drug manufacturers in China once every 30 years, according to GAO.

Woodcock also noted last week that FDA has trouble compelling information from other countries in an emergency because the agency is not permitted to build up any goodwill on that front.

FDA is not allowed to share confidential information with foreign authorities unless the agency has a formal agreement with their country. The options circulated by Kennedy include granting FDA that permission.

The Senate options, like Dingell's draft bill, also include bestowing FDA with a designated foreign inspectorate, mandatory recall authority and the power to destroy dangerous drugs rather than hold potentially counterfeit or adulterated drugs for 90 days.

The list also revealed that HELP members were asked to weigh a requirement for an electronic pedigree to help FDA track drugs through the supply chain. Energy and Commerce members are considering a track-and-trace provision as they debate Dingell's bill.

The Senate options also included requiring country-of-origin labeling for all drugs and their active ingredients. That provision is also in the House proposal.

Dingell's bill includes provisions to improve oversight for food and cosmetics as well. The HELP Committee is expected to include language on food in any comprehensive bill members propose too, but their willingness to include cosmetics is unclear.