New bill would boost FDA's drug safety muscle

  ·  Health Policy Hub

Longtime drug safety watchdog Rep. John Dingell and other members of the powerful Energy and Commerce Committee today introduced a new version of the comprehensive Drug Safety Enhancement Act, which would strengthen the FDA and close critical gaps in the safety of the U.S drug supply.

A drug safety hearing of the E&C Subcommittee on Oversight and Investigations tomorrow will provide an early opportunity to look at the ways this new bill addresses some of the complex risks that spring from an increasingly fractured and global drug supply chain.

Brought by Rep. Dingell, Ranking Member Henry Waxman, Health Subcommittee Ranking Member Frank Pallone, and Oversight Subcommittee Ranking Member Diana DeGette, the Drug Safety Enhancement Act, comes less than a month after the agency told industry, consumers and policymakers at the After Heparin conference that it needed to make bold updates and obtain new regulatory tools to keep pace with the expansion of the drug supply. The bill reflects past agency priorities and recommendations, as well.

According to a Committee statement, the bill:

  • gives the FDA important new enforcement tools it’s been asking for, including recall and subpoena authority
  • boosts inspections by generating funds for GMP inspections and requiring parity between inspections of US and foreign drug-making plants and suppliers
  • builds a higher barrier between unsafe drugs and US medicine cabinets, prohibiting drugs from sites that cannot prove or have refused, failed, or falsified inspection from entering the country
  • improves tracking by establishing a registry and unique ID numbers of all drug facilities and parties supplying the US, both foreign and domestic
“A few years ago, thousands of American lives were jeopardized by contaminated heparin stock imported from China,” said Rep. DeGette in a statement. “As pharmaceuticals and their ingredients are increasingly imported from the global marketplace, we must ensure our families can trust the medicines they rely upon by empowering the FDA.”

“We must address the deficiencies uncovered by recent recalls,” said Rep. Dingell. “The Drug Safety Enhancement Act is a strong and effective 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 to ensure we address the safety of the nation’s drug supply in a meaningful way.”

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 Community Catalyst and Pew Prescription Project's Securing a Safe Drug Supply.

--Kate Petersen, PostScript blogger