On Friday, four House members introduced important drug safety legislation aimed to better protect the drug supply through tightened import rules, inspection, tracking, and FDA resources.
The Drug Safety Enhancement Act builds off the FDA Globalization Act introduced last year, and sponsoring Reps. John Dingell, Henry Waxman, and Frank Pallone have pledged to work quickly in the next Congress to pass the bill.
Here’s what the bill does, according to Friday’s statement:
- 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.
Why drug safety now? For those regular readers of PostScript, you know our take: a rising and record number of drug recalls last year, a borderless and increasingly splintered supply chain in which manufacturers may not know where their raw materials originated, much less how safe they are, and a semi-regulated global marketplace in which many players cut corners on quality control has injected a little too much guesswork into knowing how safe and effective our drugs are. The FDA has made big strides in the last several years to tighten up gaps in the supply chain, and the bill proposed last week would help the agency and industry go further.
For updates on drug safety legislation and news, follow SafeRxWatch on Twitter.
For summaries of previous drug safety legislation, a consumer survey on drug safety, and other resources, visit the Pew Prescription Project’s Securing a Safe Drug Supply.
–Kate Petersen, PostScript blogger