Leaders of four committees in the US House of Representatives have introduced a bill — Drug Safety Enhancement Act (Bill HR 6543) — which would upgrade America’s prescription drug safety laws. This Bill proposes to equip the FDA with the authorities and resources it needs to adequately regulate the growing global marketplace for drugs.
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.
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.