Huge FDA changes in Globalization Act of '08
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.