House Draft Bill Would Require Importer/CHB Registration for Drug Imports, Etc.
House Energy and Commerce Committee leaders1 released a discussion draft of legislation on September 20, 2010 that would amend the Food, Drug, and Cosmetic Act to improve drug safety.
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Contains Importer, Broker, and Supply Chain Requirements for Drugs
According to a Committee press release, the discussion draft would:
- Import safety documentation - prohibit the entry of drugs into the U.S. which lack safety documentation;
- Supply chain controls - require manufacturers to document and ensure the safety of their supply chain;
- foreign inspections, etc. - require parity between foreign and domestic drug facility inspections and increase the number of pre-approval drug inspections;
- Mandatory recall authority - grant the Food and Drug Administration authority to mandate recalls of unsafe drugs.
In addition, the bill’s table of contents contains provisions on (partial list):
- Importer registration and fees - registration and fees for commercial importers of drugs;
- CHB registration - registration for customs brokers;
- Unique ID#s - unique identification number for establishments, importers, and customs brokers that are required to register;
- Destruction & detention of imports - destruction of adulterated, misbranded, or counterfeit drugs offered for import; administrative detention;
- Country of origin - country of origin labeling;
- Export certification - exportation certificate program; and
- Penalties -- civil and criminal penalties.
Proponents Say Bill Needed Due to Foreign Manufacturing, Scares Like Heparin
According to Senator Stupak, one of the discussion draft’s authors, the need for increased regulation was clearly demonstrated in 2008 with the tainted drug heparin, which killed 80 people. He adds that “with more and more of the U.S. drug supply being manufactured overseas, it is vital that we equip the FDA with the authority and the resources it needs to ensure that imported drugs are safe for American consumption.”
Builds on Previous Legislation, Which Later Became Basis for Food Safety Bill
The Committee adds that the discussion draft builds on the drug portions of H.R. 759, the Food and Drug Globalization Act, which contained provisions on food, drug, and cosmetics. The Committee notes that the food safety portions of H.R. 759 became the basis of H.R. 2749, the “Food Safety Enhancement Act,” which the House passed in 2009.
(See ITT’s Online Archives or 02/18/09 news, 09021820, for BP summary of H.R. 759
See ITT’s Online Archives or 09/01/09, 08/25/09, 08/12/09, 08/10/09 and 08/04/09 news, (Ref: 09090120), (Ref: 09082510), (Ref: 09081205), (Ref: 09081015) and (Ref: 09080415), for BP summaries of House-passed H.R. 2749.)
1Representatives Dingell (D), Chairman of the Energy and Commerce Committee; Waxman (D), Chairman of the Energy and Commerce Committee, Pallone (D), Chairman of the Subcommittee on Health, and Stupak (D), Chairman of the Subcommittee on Oversight and Investigations.