U.S. FDA objects to parts of House Drug Safety Plan

posted on:
June 12, 2007


 WASHINGTON – Drug safety measures pending in the House may burden regulators without protecting patients from dangerous medicines, a senior Food and Drug Administration official told lawmakers Tuesday. 

Detailed monitoring plans and regular reassessments of every new drug are unnecessary and duplicate other efforts, said Randall Lutter, FDA deputy commissioner for policy.

The agency currently develops plans to minimize risks for drugs with concerns, and will be able to do a better job if Congress approves more funding and authorizes stepped-up surveillance for problems, he said.

Some reforms being considered in the House, which are tougher than a similar Senate bill, "seem fixed on process and structural changes and not on making fundamental improvements in the science of drug safety," Lutter told the House Energy and Commerce subcommittee on health.

"Such changes could limit access to needed medicines and slow down new innovations while doing little to address the core issues of drug safety," Lutter added.

The Senate passed a bill in May to give the agency new powers to monitor side effects and order post-approval studies. A draft House measure has more far-reaching provisions including limits on drug advertising on television.

The legislation is a response to the 2004 withdrawal of Merck & Co Inc.'s arthritis pill Vioxx and side-effect concerns with other prescription drugs.

The FDA came under fire for being slow to respond to signs of problems with Vioxx, a criticism echoed in recent weeks as safety questions emerged about GlaxoSmithKline Plc's diabetes drug Avandia.

"It is very clear that there are gaping holes in the current system and the public has lost a great amount of confidence in FDA's ability to protect them from potentially harmful drugs," said Rep. Frank Pallone, a New Jersey Democrat and the subcommittee chairman.

The health subcommittee is scheduled to vote on a bill on Thursday. The House and Senate must merge their approaches before legislation can go to President Bush for his signature into law.

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