The so-called Discussion Draft is meant to stimulate chatter about how to provide adequate funding and authority for FDA to ensure the safety of the nation’s food, drug, medical device, and cosmetic supply, according to the House Energy and Commerce Committee, which intends to hold hearings over the next few weeks and to markup legislation shortly thereafter.This is the text.
The bill, by the way, would be known as the Food and Drug Administration Globalization Act of 2008, and builds on four other pieces of legislation - HR 3610, HR 3624, HR 3484 and HR 3115 - as well as the investigations conducted by the Oversight and Investigations Subcommittee of the Committee on Energy and Commerce and the report of the FDA Science Board’s Subcommittee on Science and Technology, among other things. These are the specific issues concerning drugs and devices...
- Create an up-to-date registry of all drug and device facilities serving American consumers: Require all drug and device facilities operating within the US or exporting products to the US to register with FDA annually;
- Generate resources to support inspections: Registration would require payment of a fee that covers the cost of drug and device inspections by FDA;
- Require parity between foreign and domestic inspections: Require FDA to inspect foreign and domestic drug and device facilities every two years. Prohibit any manufacturer from introducing a drug, drug ingredient, or device into interstate commerce until an initial facility inspection has occurred. Refusing, impeding, or delaying an inspection would be cause for suspension of registration;
- Restrict entry of imports lacking documentation of safety: After a phase-in period, require importers of drugs for commercial use who lack documentation of compliance with requirements related to identity, safety, and purity to ship products only through ports of entry with federal testing labs;
- Require verification of drug identity and purity: Require manufacturers of drugs and drug ingredients to test for contaminants;
- Create strong new enforcement tools: Allow the FDA to issue fines for violations of drug safety requirements. Extend current FDA authority to recall dangerous medical devices to include drugs. Extend current FDA authority to detain unsafe medical devices discovered during inspections to include drugs. Allow the FDA to destroy counterfeit or adulterated commercial imports;
- Require country-of-origin labeling: Require drug labels to identify the source of the active pharmaceutical ingredient and its place of manufacture. Require device labels to indicate the country of manufacture;