Today Rep. John D. Dingell, Chairman Emeritus of the Energy and Commerce Committee, Rep. Henry A. Waxman, Chairman of the Energy and Commerce Committee, Rep. Frank Pallone, Chairman of the Subcommittee on Health, and Rep. Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, introduced H.R. 6543, The Drug Safety Enhancement Act, which would equip the Food and Drug Administration (FDA) with the authorities and resources it needs to adequately regulate the growing global marketplace for drugs.
More and more drugs marketed in the U.S. are being developed and manufactured abroad. High-profile risks associated with the globalized drug supply like the heparin crisis of 2007 have put American lives at risk. These alarming risks highlight why FDA needs additional authorities and greater resources to ensure the safety of an increasingly global drug supply. H.R. 6543 provides tough new directives to protect consumers from unsafe drugs. This legislation builds on H.R. 759, the Food and Drug Globalization Act, which was introduced by Dingell, Pallone and Stupak last year, and reflects the reasoned priorities and recommendations of the Food and Drug Administration (FDA).
* Creates an up-to-date registry of all drug facilities--both foreign and domestic--serving American consumers;
* Generates funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs;
* Requires parity between foreign and domestic inspections;
* Prohibits entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections;
* Prohibits the entry of drugs into the U.S. lacking documentation of safety;
* Requires manufacturers to know their supply chain, identify and mitigate risk throughout their supply chain, and to document measures taken to secure their supply chain;
* Prohibits false or misleading reports to FDA;
* Provides strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations;
* Provides protection for whistleblowers that bring attention to important safety information; and
* Requires 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.
"Americans have been constantly reminded over the years of the challenges FDA and the industry face in ensuring the safety of the U.S. drug supply. We must address the deficiencies that have been uncovered by recent recalls. Pharmaceuticals need better oversight and we must empower FDA with the capacity to duly protect American consumers," said Dingell. "H.R. 6543 is a balanced 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 during the next Congress to ensure we address the safety of the nation's drug supply in a meaningful way."
"In recent years, our domestic drug supply has become an increasingly globalized one," said Rep. Waxman. "Unfortunately, FDA lacks the proper authorities and enforcement tools to help fully protect us from the new threats posed by this system, as illustrated by the heparin catastrophe of 2007. This legislation will provide the tools and resources the agency needs to do just that. I look forward to working with my colleagues in the next Congress to move this critically important bill as soon as possible."
"The Drug Safety Act will upgrade safety standards for prescription drugs and empower the FDA with the authority to enforce these standards," said Pallone. "Doctors and patients need to have confidence in the safety and effectiveness of the medicine they rely upon to treat illness and improve health. This legislation will give the FDA the resources it needs to help ensure the safety and integrity of the production and distribution of the nation's prescription drug supply."
"My hearings and investigations over the years have clearly shown our drug safety laws are out of date, especially as more of our pharmaceutical products continue to come from overseas," said Stupak. "This legislation would finally arm the FDA with the tools and resources to effectively monitor imported drugs and protect Americans from potential contamination in the medications they take. I urge the next Congress to make drug safety a priority and work quickly to pass this bill that will protect American consumers."