Sen. Ted Kennedy, D-Mass., is crafting a bill to strengthen FDA's oversight of products manufactured overseas, including devices.

Kennedy's language is similar to a draft that has been publicly released by Democrats in the House, but the Senate approach appears to offer FDA and industry more flexibility.

Democrats on the House Energy and Commerce Committee issued the FDA Globalization Act in the form of a "discussion draft" April 17.

The House draft would give the agency power to collect new fees from the device industry to help support inspections of foreign facilities, and would require FDA to inspect device and drug manufacturing plants more frequently than the current practice (¹ Also see "Draft House Bill Seeks To Strengthen FDA’s Role In Device Import Safety" - Medtech Insight, 21 April, 2008., p. 6).

House Hearing On Device Provisions This Week

Device industry lobbyists are gearing up for an Energy and Commerce Health Subcommittee hearing on May 14, when they will try to convince lawmakers to rethink several provisions in the draft bill.

The hearing will focus on the device and cosmetic provisions in the discussion draft. The subcommittee has previously held hearings on the food and drug sections.

In particular, device companies oppose the draft's requirement for a new industry registration fee (of an amount FDA would determine) that would be collected from all device facilities, including those located in the U.S. Instead, industry reps will be pushing for a more targeted fee that would be assessed only on foreign facilities producing products exported into the U.S.

Industry is also aiming to remove the House draft bill's requirement that FDA inspect a domestic or foreign manufacturing facility prior to approving or clearing any class II or III device for marketing. Currently, pre-approval inspections are only required for PMA approvals, not class II 510(k)s.

Further, lobbyists want to revise the House language that would require FDA to inspect foreign facilities every two years. This technically would match current requirements for domestic facilities, but device reps are pushing for a more flexible risk-based inspection approach, which FDA currently applies in practice for domestic facilities (² Also see "OC FY 2005 Priorities: MDUFMA, Bioterror, Closing Out Enforcement Actions" - Medtech Insight, 6 December, 2004., p. 5).

The Senate draft, which has yet to be publicly posted but which is being circulated within the Health, Education, Labor and Pensions Committee, would not expand FDA's pre-market inspection mandate.

Further, it lays out a risk-based inspection approach. At first, FDA would be required to stick to the two-year inspection interval for both domestic and foreign facilities. But ultimately, the agency could adjust the interval for each facility based on perceived risk. FDA could inspect facilities more frequently than once every two years or as little as once every five years.

Talk Of New Industry Fees

The Senate language, as it currently stands, does include new across-the-board industry fees to help support FDA inspection activities. Kennedy's version leaves the fee amounts up to Congress (to supplement the appropriations package) rather than up to FDA.

Industry reps acknowledge that Congress is under pressure to pass a bill strengthening FDA's international oversight this year, particularly in light of the ongoing controversy over tainted heparin imported from China. But they say they will oppose the bill unless, at minimum, the fee and new inspection requirements are changed.

Rep. John Dingell, chairman of the House Energy and Commerce Committee, has signaled that he plans to mark up the Globalization Act soon after Wednesday's hearing. Sen. Kennedy's office has not given a timeline for his bill.

- David Filmore (d.filmore@elsevier.com)

Senate Crafts Import Safety Bill, As Device Reps Prep For House Hearing

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