August 7th, 2009

Reports Reuters:

The U.S. Food and Drug Administration’s top official vowed on Thursday to warn companies more quickly about problems found during inspections and act more aggressively in serious cases that could directly harm consumers and patients.

The move “will help to ensure that violations are taken seriously, that warning letters and enforcement actions occur in a timely manner,” FDA Commissioner Margaret Hamburg said in remarks at a Food and Drug Law Institute event.

Hamburg said the agency would no longer require all warning letters be reviewed by the agency’s top lawyer before being sent to manufacturers except in certain, more legally complex cases.

That system caused “unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long” and put the public’s health at risk, she said.

The FDA began funneling all warning letters through its chief counsel’s office during the Bush administration. Critics said the move was a favor to makers of drugs, medical devices and other products as it slowed the process and reduced the number of warnings.

Read more at Reuters.