FDAnews
www.fdanews.com/articles/96899-dingell-introduces-draft-legislation-to-increase-import-inspections

Dingell Introduces Draft Legislation to Increase Import Inspections

August 7, 2007

Rep. John Dingell (D-Mich.) Aug. 3 introduced draft legislation that would establish a user fee on imported drug shipments to hire more inspectors at the U.S. border and in FDA laboratories.

The user fees would be used to test samples of drug imports and research new testing techniques, according to an announcement from the House Energy and Commerce Committee, which Dingell chairs. The bill would also create a similar user fee and new programs for imported food products.

The greatest priority for using the fees would be for inspections and testing to detect intentional adulteration or misbranding of drugs, according to the committee.

In addition, the bill would give the FDA the authority to call for mandatory recalls, and would increase civil monetary penalties for manufacturers and importers who do not comply with the Federal Food, Drug and Cosmetic Act. The civil monetary penalties would be raised to $100,000 for an individual and $500,000 for a company introducing or delivering a noncompliant product, with a maximum of $1 million for all issues in a single proceeding, according to the committee.

The draft legislation can be viewed at energycommerce.house.gov/China Food Safety/Food Safety Draft Bill.pdf.