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Patricia Van Arnum was executive editor 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:
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.
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FDA Commissioner Testifies Before Congress on Foreign Inspection ProcessCongress Focuses on FDA Inspections of Foreign Drug FacilitiesWorking Group Releases Strategy to Ensure Import Safety