Drug Safety Enhancement Act of 2011 Draws Concern

The proposed Drug Safety Enhancement Act of 2011 (HR 1483) (Rep. Dingell D-MI) has the India based Pharmaceutical Export Promotion Council (Pharmexcil) asking exporters in their country to share their comments and apprehensions about the Act, that if passed, would require:

  • Drug establishments to maintain records on the supply chain of the drug, ingredients, and raw materials;
  • Establishes the frequency of inspections of drug establishments and prohibits delaying or limiting an inspection;
  • Gives the Secretary authority to order the recall of, detain, destroy, and seize drugs as necessary;
  • Establishes civil and criminal penalties for violations of Federal Food Drug & Cosmetic Act provisions; and
  • Authorizes the Secretary to require documentation of an imported drug and refuse admission if such documentation is not provided.

The proposed Act also requires drug manufacturers to: (1) implement an effective quality system that requires compliance with current good manufacturing practices and timely communication of product quality issues; (2) establish risk management procedures that ensure effective risk assessment, control, and communication; and (3) establish procedures that ensure the safety, identity, quality, strength, purity, and security of all drugs and other materials used by the manufacturer. The Act would also establish a dedicated foreign inspectorate.

Of the Act, Rep Dingell said:

“For too long, Americans have suffered from the challenges FDA and the industry face in ensuring the safety of the U.S. drug supply.  We must address the deficiencies uncovered by recent recalls,” said Rep. John D. Dingell (MI-15). “The Drug Safety Enhancement Act is a strong and effective response to the troubles we face with an increasingly global and complex drug supply.  I look forward to working with my colleagues on both sides of the aisle, consumer advocates, and the regulated industry to ensure we address the safety of the nation’s drug supply in a meaningful way.”


With little information to go on, it would seem Pharmexcil’s concern over the bill would involve the issue of foreign inspections, and the act’s statement that the United States would retain extraterritorial jurisdiction over any violation of the Act as it related to any drug if such drug was intended for import into the United States. The US has long worried about the quality of drugs imported from foreign countries, prompting the FDA to provide information to consumers on imported drugs. It would appear that amidst this request by Pharmexcil, H.R. 1483 is worth keeping an eye on as Congress reconvenes.