Proposed Legislation Calls for User Fee on Drug Imports

September 26, 2007
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

Rep. John D. Dingell (D-MI), chairman of the Committee on Energy and Commerce, along with Reps. Frank Pallone (D-MI), chairman of the Subcommittee on Health, and Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations, introduced legislation that would create a user fee on imported drug and food shipments.

Washington, DC (Sept. 20)-Rep. John D. Dingell (D-MI), chairman of the Committee on Energy and Commerce, along with Reps. Frank Pallone (D-MI), chairman of the Subcommittee on Health, and Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations, introduced legislation that would create a user fee on imported drug and food shipments.

“Increasing reports of contaminated imports have made it clear that the FDA does not have the resources and authority it needs to ensure the safety of our food and drug supply,” said Dingel in a prepared statement. “This puts every American consumer at risk.”

The Committee on Energy and Commerce is conducting a broad investigation into the safety of the nation’s drug and food supply, particularly the ability of the US Food and Drug Administration to adequately conduct inspections and perform laboratory analysis.

The legislation, H.R. 3610, the “Food and Drug Import Safety Act of 2007,” would specifically create a user fee on imported drug and food shipments. Funds generated by the fee would be used to hire additional personnel to perform inspections at the US border, abroad, and at FDA laboratories to increase analysis of drug and food imports. Funds would also be used to test import samples and research new testing techniques.

The legislation would also prevent the Secretary of Health and Human Services from closing or consolidating any of the current 13 FDA field laboratories and grant the agency new authority to:

• Issue mandatory recalls

• Require country-of-origin labeling for drugs, medical devices, and food

• Halt imports of certain products until a foreign facility can demonstrate that significant steps have been taken to rectify an identified problem

• Increase civil monetary penalties for manufacturers or importers that violate the Federal Food, Drug and Cosmetic Act.

A legislative hearing on this bill in the Subcommittee on Health was planned for Sept. 26.

Related stories

Working Group Releases Strategy to Ensure Import Safety (Sept. 13, 2007)

Senator Questions FDA’s Foreign Inspections (Aug. 16, 2007)