FDA chief vows to speed up inspections, warnings

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.

The move will ensure, “that warning letters and enforcement actions occur in a timely manner and that steps are taken to protect consumers in cases where immediate enforcement action is not possible,” FDA Commissioner Margaret Hamburg said in remarks prepared for delivery at a Food and Drug Law Institute event.

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

That system has 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 also will move quickly to close cases after a company fixed any problems uncovered during an inspection and it would make such information public, Hamburg said.

FDA officials issue warning letters to drugmakers and other manufacturers for everything from unsanitary conditions and faulty equipment to problems with record keeping and other procedures.

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.

WASHINGTON (Reuters)