Huge FDA changes in Globalization Act of '08

Share this article:
Three key leaders of the House Energy and Commerce Committee are circulating a discussion draft of their proposed Food and Drug Administration Globalization Act of 2008 as a means to provide adequate funding and authority for the FDA to ensure safety of the nation's food, drug, medical device and cosmetic supply in an increasingly globalized marketplace.

A cover memo circulated by Reps. John Dingell (D-MI), Frank Pallone (D-NJ) and Bart Stupak (D-MI) in April said they intend to hold legislative hearings on the draft soon. 

The proposal would: create a registry of drug and device facilities serving US consumers; require payment of fees to fund drug and device inspections; require parity between foreign and domestic inspections so facilities are inspected every two years; restrict entry of imports lacking safety documentation; require verification of drug identity and purity; and other provisions.

“This discussion draft raises challenging policy questions, and we anticipate a vigorous debate on these issues,” the three lawmakers said.

This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Your use of this website constitutes acceptance of Haymarket Media's Privacy Policy and Terms & Conditions