New Drug Safety Bill Introduced in House
On December 17, 2010, Representative Dingell1 Introduced H.R. 6543, the Drug Safety Enhancement Act, a bill to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes.
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H.R. 6543 has been referred to the House Energy and Commerce Committee and is not in effect. Given the short time remaining in the current congressional session, H.R. 6543 is expected to be reintroduced in the next (112th) Congress.
(Generally, in order for a bill to be implemented, identical versions of that bill must be passed by both the House and Senate, and then the bill must be approved (enacted) by the President.)
Bill Based on Earlier Measure That Was the Genesis of Food Safety Bill
According to a press release from Representative Dingell, H.R. 6543 would provide tough new directives to protect consumers from unsafe drugs. The 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. 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. The Senate recently passed its own version of food safety legislation which is awaiting action by the House.
H.R. 6543 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 American 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.
Dingell Urges Next Congress to Make Drug Safety a Priority and Pass H.R. 6543
According to Dingell, H.R. 6543 would arm the FDA with the tools and resources to effectively monitor imported drugs and protect Americans from potential contamination in the medications they take. He urges the next Congress to make drug safety a priority and work quickly to pass H.R. 6543.
1Along with co-sponsors Palone (D), Stupak (D), and Waxman (D).