Sen. Kennedy builds list for strengthening FDA

WASHINGTON Senate Health, Education, Labor and Pensions chairman Edward Kennedy, D-Mass., has sent out a list of options for strengthening drug and device safety that might be included in legislation to improve the Food and Drug Administration, according to published reports.

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 Chairman John Dingell, D-Mich., but unlike Dingell’s plan, one of the Senate options includes giving FDA the power to base its inspections on risk.

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 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.