House Democratic Leaders Introduce Revised Version Of Bill To Strengthen FDA Oversight Of Imported Goods, Food

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Nutrition / Diet;  Pharmacy / Pharmacist;  Public Health
Article Date: 30 Jan 2009 - 4:00 PDT

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Three Democratic members of the House Energy and Commerce Committee on Wednesday introduced a revised version of a 2008 draft bill that aims to strengthen FDA's regulatory powers and ensure the safety of imported pharmaceutical medications, medical devices, generic drug products and food, Dow Jones reports. According to Dow Jones, the new bill (HR 759) -- also known as the FDA Globalization Act -- is based on the 2008 measure first introduced by then-committee Chair John Dingell (D-Mich.) that "provoked outrage" from some pharmaceutical companies and other FDA-related industries because of its proposed new fees and bolstered inspection provisions (Favole, Dow Jones, 1/28).

The updated bill, co-sponsored by Dingell, Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) and Health Subcommittee Chair Frank Pallone (D-N.J.), would set industry registration fees for manufacturers of medications, medical devices and food products to fund more FDA inspections of facilities; require generic drugmakers to pay a user fee to cover the cost for manufacturing facility inspections; and authorize FDA to institute fines or recalls for medications and medical devices it deems unsafe, among other new agency enforcement capabilities (CongressDaily, 1/28). The bill would also require all foreign drug and medical device production facilities to undergo biennial inspections funded by proposed fees on imported products. Domestic drugmakers already undergo biennial FDA inspections (Dow Jones, 1/28).

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