Congress Introduces FDA Globalization Act of 2009

February 12, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety, including registration of producers of drugs and applicable fees, documentation for admissibility of drug imports, country of origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API).

Washington, DC (Jan. 28)-Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety. The 2009 bill also contains several revisions to the Globalization Act of 2008 (see related PharmTech articles below). The bill would require registration of and fees for drug manufacturers, documentation for admissibility of drug imports, country- of-origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API). Excipients for drugs are not covered under the bill.

The bill calls for increased inspection of facilities, which would be funded by an annual fee. For each fiscal year 2010 to 2014, the annual fee setting would be established to generate a total revenue amount. The Secretary of Health and Human Services would be required to submit to Congress the total revenue amount by Sept. 1, 2010. The annual fee amounts would be based on differences in cost between inspections of foreign and domestic facilities. If passed, facilities would be inspected every two years or every four years, depending on the results of risk assessment.

The bill also discusses implementation of quality risk management plans for drug and API facilities and requires that manufacturers submit supply-chain documentation in electronic form.

At press time, the bill had been referred to the Committee on Energy and Commerce for review. It will then be sent to the House of Representatives.

Related PharmTech articles:

Evaluating the Pieces of the Pharma Supply Chain

Lawmakers Pledge to Move on FDA Reform in the Next Congress

Dingell Aims to Boost FDA Funding

Senate Introduces Bill for Country-Of-Origin Labeling for Pharmaceutical Ingredients

Congress, FDA Weigh in on Measures to Improve Drug Safety

Congressional Hearings Focus on Foreign Inspection Process