FDA Drug Safety Bill Introduced in House
On April 12, 2011, Representative Dingell (D) introduced H.R. 1483, the Drug Safety Enhancement Act, which he states would equip the Food and Drug Administration with the authorities and resources it needs to adequately regulate the growing global marketplace for pharmaceuticals.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
(Representative Waxman (D), Ranking Member of the Energy and Commerce Committee, Representative Pallone (D), Ranking Member of the Subcommittee on Health, and Reprepresentative DeGette (D), Ranking Member of the Subcommittee on Oversight and Investigations joined Dingell in introducing the bill.)
Based on Earlier Measure That Was Genesis of Food Safety Bill
According to Dingell’s press release, this legislation builds on H.R. 759, the Food and Drug Globalization Act, which was introduced by Dingell, Pallone and Stupak in 2009 and which contained provisions on food, drug, and cosmetics. These provisions were since separated into separate bills and modified, with the Senate providing its own versions. One such bill, the Food Safety Modernization Act, became law on January 4, 2011. (See ITT’s Online Archives or 01/04/11 news, 11010426, for a BP summary.)
Would Deny Entry to Drugs Lacking Safety Doc’s, Require Supply Chain Risk Mitigation, Etc.
According to Representative Dingell, the Drug Safety Enhancement Act would:
- Prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections;
- Prohibit the entry of drugs into the U.S. lacking documentation of safety;
- Require manufacturers to know their supply chain, identify and mitigate risk throughout their supply chain, and to document measures taken to secure their supply chain;
- Provide strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations
- Create an up-to-date registry of all drug facilities—both foreign and domestic—serving U.S. consumers;
- Generate funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs;
- Require parity between foreign and domestic inspections;
- Prohibit false or misleading reports to FDA;
- Provide protection for whistleblowers that bring attention to important safety information; and
- Require unique identification numbers for drug establishments and importers to improve the ability of the FDA to more quickly identify parties involved in a crisis situation.
(See ITT’s Online Archives or 12/21/10 news, 10122118, for BP summary of H.R. 6543 which appears to be substantially similar to the current bill, and which Representative Dingell said he would reintroduce in the 112th Congress.)