H.R. 5752, Stop Illicit Drug Importation Act of 2018

Floor Situation

On Tuesday, June 12, 2018, the House will consider H.R.5752, the Stop Illicit Drug Importation Act of 2018, under suspension of the rules. This bill was introduced on May 10, 2018 by Rep. Marsha Blackburn (R-TN) and was referred to the House Committee on Energy and Commerce, which ordered the bill reported, as amended, by voice vote on May 17, 2018.

Summary

H.R. 5752 amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administration’s (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act.

Background

To prevent harmful goods from reaching consumers, the FD&C Act provides for the seizure of foods, drugs, devices, cosmetics, and tobacco products that are adulterated or misbranded. While FDA currently lacks authority to seize products, the U.S. Attorney may take such actions based on FDA's recommendation. In general, the U.S. Attorney commences a seizure action by filing a complaint in federal court on behalf of FDA and obtaining a warrant that directs the U.S. Marshal to take custody of the goods.

Under the FD&C Act, when a product may be seized depends on the product type and the alleged violation. In general, seizure proceedings involving food, drugs, and cosmetics may be initiated "when introduced into or while in interstate commerce or while held for sale ... after shipment in interstate commerce." However, for counterfeit drugs and the materials used to make them, as well as adulterated or misbranded medical devices and tobacco products, seizure may occur at any time, and before a complaint is filed. FDA may impose monetary civil penalties as well relating to prescription drug marketing practices, medical devices, electronic products, tobacco products, pesticide residues in food, generic drug applications, and improper dissemination of direct-to-consumer advertisements for approved drugs or biological products. The maximum penalty that FDA may assess ranges from approximately $1,000 to over $1 million per violation depending on the prohibited act.

Cost

The Congressional Budget Office (CBO) estimates that implementing H.R 5752 would generate an insignificant net increase in revenues over the 2019-2028 period. (page 11).

Staff Contact

For questions or further information please contact Jake Vreeburg with the House Republican Policy Committee by email or at 2-1374.