Senator Chuck Grassley today introduced legislation with Senator Ted Kennedy to give the Food and Drug Administration (FDA) more resources to inspect domestic and foreign-made prescription drugs and devices.
The bipartisan legislation also responds to concerns about medical device reviews by the FDA and calls for an Institute of Medicine study to examine the FDA’s system for approving devices.
The Drug and Device Accountability Act of 2009 is similar to legislation introduced last year by Grassley and Kennedy.
“An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn’t know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year,” Grassley said. “Our legislation is a practical solution to beefing up the FDA’s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency’s work.”
The Drug and Device Accountability Act would augment the FDA’s resources through the collection of inspection fees. The bill also would expand the FDA’s authority, including new subpoena powers, for ensuring the safety of drugs and medical devices made domestically and in other countries. Finally, the bill would require certification of applications for drugs and devices needing FDA approval and establish civil and criminal penalties for false or misleading certifications.
The Bill Covers:
· Enhanced Registration and Inspection of Drug and Device
· Ensuring Identity and Sourcing of Drug Ingredients
· Ensuring Standards for Imported Drugs
· Enhanced Response to Unsafe Drugs
· Certification of information
· Whistleblower protections.
Protecting the pharmaceutical and food supply chains from contamination is exactly the role of the FDA, and this type of legislation meets the mandates of what the Food and Drug Administration should be doing.
This legislation comes at a time when FDA’s role seems to be ill defined, where its policies remind us more of waves at the beach than uniform code and enforcement.