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.
Hamburg told reporters after her speech that her decision to revert to the agency's prior policy was simply an issue of looking at what makes sense. More warning letters could be issued as result, at least in the near term, she added.
Companies are supposed to follow the agency's manufacturing guidelines with FDA inspectors making periodic checks.
The agency can later issue warning letters to drugmakers and other manufacturers for everything from unsanitary conditions and faulty equipment to problems with record-keeping and other processes. It also issues them for misleading advertising.
Warning letters are often routine, with companies resolving the problems without the agency taking further action such as fines and injunctions. But in more serious cases, the warnings can dent a company's stock and lead to product seizures or other penalties.
Our expectation is that companies will work to quickly and thoroughly correct deficiencies and ensure safety. Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act, we will, Hamburg said in her speech.
Under the new policy, companies will have no more than 15 working days to respond to the FDA before the agency issues a letter or takes other action.
The FDA also will move quickly to close cases after a company fixed any problems uncovered during an inspection and it would make such information public, which would help make it clear when a company's issues are resolved, Hamburg said.
She added that the agency needs Congress to give it more enforcement authority, including mandatory recall power, something included for foods in a bill passed by the U.S. House of Representatives last week. Right now, the agency tries to work out voluntary recalls with companies.
Critics say the FDA has been hampered in its ability to inspect manufacturers in recent years, plagued by a lack of adequate staff and funding. Hamburg said the recent boost to its budget by Congress for the rest of 2009 and 2010 would help.