August 18, 2008
Tougher FDA enforcement in the works
House Energy and Commerce Committee chairman John Dingell (D-MI) is circulating a revised draft of his proposed FDA Globalization Act, incorporating changes negotiated by committee staffers with the FDA and the drug industry since the original draft was released in April. Committee spokeswoman Brin Frazier said in the first week of August that changes, including hefty new monetary and imprisonment penalties for violations, were still being worked on and none had been finalized.
The revision applies only to the drug safety section and would lengthen the time for risk-based inspections of manufacturing facilities to once every four years. FDA officials reportedly told the committee they needed such flexibility to allocate limited resources based on risk. The revision would require the FDA to establish a system for assessing risk and determining inspection intervals within three years of the bill's passage.
The amount to be charged in registration fees to cover the costs of new safety activities has not been determined. There are strengthened drug pedigree requirements and subpoena powers for the FDA, and a condition for labeling to show the active ingredients' country of origin.
Co-sponsored with Reps. Frank Pallone (D-NJ) and Bart Stupak (D-MI), the proposed bill is widely regarded as being the possible genesis of the most sweeping FDA overhaul in a generation.