House Democratic leaders are trying to drum up support for a bill that would give the Food and Drug Administration (FDA) more resources to regulate the global drug marketplace.
More and more drugs are produced overseas, presenting an “alarming” risk to consumer safety, said Democratic Reps. John Dingell, (Mich.), Henry Waxman (Calif.), Frank Pallone (N.J.) and Bart Stupak (Mich.), who sponsored the bill.
According to a joint statement, the bill:
• creates an up-to-date registry of all drug facilities — both foreign and domestic — serving American consumers;
• generates funding for increased Good Manufacturing Practices 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.