Leaders of four committees in the US House of Representatives have introduced a bill which would upgrade America’s “out-of-date” prescription drug safety laws.
The Drug Safety Enhancement Act (Bill HR 6543), which builds on the Food and Drug Globalization Act (HR 759) introduced by three of the sponsors last year, will equip the Food and Drug Administration (FDA) with the authorities and resources it needs to adequately regulate the growing global marketplace for drugs, say the sponsors, all Democrats.
HR 6543 would:
• create an up-to-date registry of all drug facilities, both foreign and domestic, serving US consumers;
• generate funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs;
• require parity between foreign and domestic inspections;
• prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections;
• prohibit the entry of drugs into the US lacking documentation of safety;
• require manufacturers to know their supply chain, identify and mitigate risk throughout the chain, and to document measures taken to secure their supply chain;
• prohibit false or misleading reports to FDA;
• 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;
• provide protection for whistleblowers who bring attention to important safety information; and
• require unique identification numbers for drug establishments and importers to improve the FDA’s ability to identify parties involved in a crisis situation more quickly.
“HR 6543 is a balanced response to the troubles we face with an increasingly global and complex drug supply,” said Representative John Dingell, chairman emeritus of the House Energy and Commerce Committee and one of the bill’s sponsors.
“In recent years, our domestic drug supply has become an increasingly globalised one. 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,” added Representative Henry Waxman, chairman of the Energy and Commerce Committee, another sponsor.
“Doctors and patients need to have confidence in the safety and effectiveness of the medicine they rely upon to treat illness and improve health,” said Representative Frank Pallone, a third sponsor and chairman of the House Subcommittee on Health, while the fourth, Representative Bart Stupak, chairman of the Subcommittee on Oversight and Investigations, noted that his 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.”
“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,” he said.
In the Senate, HR 6543 was welcomed by Democrats Tom Harkin and Michael Bennet, who are chairman and member, respectively, of the Senate Health Education Labor and Pensions (HELP) Committee.
Earlier this year, Sen Bennet introduced the Drug Safety and Accountability Act of 2010, which seeks to strengthen manufacturer standards, improve FDA tracking of overseas production sites and give the agency authority to recall potentially dangerous drugs. The bill would give the FDA new tools to investigate threats to drug quality and safety, with additional enforcement options, and would provide new oversight of over-the-counter (OTC) drugs. Sen Bennet plans to re-introduce the bill next year in the new Congress.
In 2009, there were a record 1,742 drug recalls in the US - a fourfold increase from the prior year - and the vast majority were related to manufacturing quality and testing. Up to 80% of the active ingredients in US drugs are now made overseas, many in countries where regulatory oversight does not meet U.S. standards, say the bills’ supporters.