Congress Moves to Improve FDA's Inspection Process

Published on: April 22, 2008

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US House of Representatives Energy and Commerce Committee is proposing legislation to address the funding and authority of the US Food and Drug Administration in regulating the safety of the country's drug supply.

Washington, DC (Apr. 17)-The US House of Representatives Energy and Commerce Committee is proposing legislation to address the funding and authority of the US Food and Drug Administration in regulating the safety of the country’s drug supply. Among the measures under consideration are requirements for: parity between foreign and domestic inspections of drug-manufacturing facilities, registration fees to finance the cost of inspections, annual registration of drug-manufacturing facilities operating in the United States or exporting products to the US, and country-of-origin labeling of active pharmaceutical ingredients (APIs).

These proposals were announced by Committee Chairman John D. Dingel (D-MI), Subcommittee on Health Chairman Frank Pallone, Jr., (D-NJ), and Subcommittee on Oversight and Investigations Chairman Bart Stupak (D-MI) as a discussion draft of the Food and Drug Administration Globalization Act of 2008.

The discussion draft is designed to stimulate discussion about how to provide adequate funding and authority for FDA to ensure the safety of the country’s drug, medical device, food, and cosmetics supply. The committee plans to hold hearings on the draft over the next several weeks and to mark up legislation shortly.

The proposed measures include:

Creating an up-to-date registry of all drug and device facilities operating within the US or exporting products to the US. These facilities would be required to register annually with FDA. Registration would require payment of an annual fee to cover the cost of FDA inspections.

Requiring FDA to inspect foreign and domestic drug and device facilities every two years. Manufacturers would be prohibited from introducing a drug, drug ingredient, or device into interstate commerce until an initial facility inspection has occurred. Registration would be suspended for refusing, impeding, or delaying an inspection.

Restricting entry of imports lacking certain compliance documentation. After a phase-in period, importers of drugs for commercial use who lack compliance documentation relating to identity, safety, and purity would be required to ship products only through ports of entry with federal testing laboratories.

Requiring manufacturers of drugs and drug ingredients to test for contaminants

Allowing FDA to issue fines for violations of drug-safety requirements, extending FDA’s authority to recall drugs and detain unsafe drugs discovered during inspections, and allowing FDA to destroy counterfeit or adulterated commercial imports

Requiring drug labels to identify the source of the API and its place of manufacture and to require device labels to indicate the country of manufacture

Creating a dedicated foreign inspectorate within FDA

Prohibiting FDA from closing or consolidating any of the 13 field laboratories or 20 district offices that were operational as of Jan. 1, 2007.

The discussion draft builds on four other bills (H.R. 3610, H.R. 3624, H.R. 3115, and H.R. 3484) and investigations conducted by the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations, a report from FDA Science Board’s Subcommittee on Science and Technology, the Administration’s Food Protection Plan and Import Plan, and input from other stakeholders.