House Introduces Discussion Draft for Drug and Food Safety

June 4, 2009
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Members of the House Committee on Energy and Commerce, Chair Emeritus John D. Dingell (D-MI), Chair Henry A. Waxman (D-CA), and Reps. Frank Pallone (D-NJ), Bart Stupak (D-MI), Diana DeGette (D-CO) and Betty Sutton (D-OH) released last week a discussion draft of the Food Safety Enhancement Act of 2009.

Members of the House Committee on Energy and Commerce, Chair Emeritus John D. Dingell (D-MI), Chair Henry A. Waxman (D-CA), and Reps. Frank Pallone (D-NJ), Bart Stupak (D-MI), Diana DeGette (D-CO), and Betty Sutton (D-OH) released last week a discussion draft of the Food Safety Enhancement Act of 2009. The draft is largely based on the food provisions of H.R. 759, the Food and Drug Administration Globalization Act of 2009, introduced in January by Reps. Dingell, Stupak, and Pallone.

The Food Safety Enhancement Act of 2009 incorporates technical assistance from the new Administration as well as other stakeholders. The legislation grants the US Food and Drug Administration the authorities and resources it needs to better ensure the safety of the nation's food supply. The committee scheduled a legislative hearing for June 3, 2009.

Although the discussion draft largely centers on food safety, the draft also contains measures relating to drug safety and general enforcement provisions as follows:

• Requires all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee

• To enhance information about FDA-regulated entities, creates unique identification numbers for all drug, device, and food facilities and importers

• Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers

• Grants FDA new authority to subpoena records related to possible violations

• Prohibits entities regulated by FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.

Read an executive summary of the discussion draft.