The speech, given to an audience of food and drug lawyers, was the first time Hamburg has spoken publicly on the enforcement of food safety since her confirmation as Food and Drug Administration (FDA) Commissioner on May 18. She used it to highlight her commitment to restoring the image of the agency, which has seen its reputation suffer as a wave of foodborne illnesses has struck the nation in recent years.
She said that the FDA will work more quickly to warn companies about safety violations, and in cases where there is perceived to be a serious risk to public health, the FDA would consider “immediate action – even before we have issued a formal warning letter.”
“The FDA must show industry and consumers that we are on the job,” she said. “We must publicize our enforcement actions – and the rationale for those actions – widely and effectively. This will increase public confidence, encourage compliance, and educate patients and consumers about potential risks.”
‘Close-out’ letters
Hamburg also outlined plans to develop a formal ‘close-out’ process after a firm has corrected violations detailed in a warning letter, providing it with a ‘close-out’ letter to show that the agency’s concerns have been successfully addressed. Issuance of ‘close-out’ letters will be indicated on the FDA’s website.
“For ongoing violations, it could play an important motivating role in spurring corrective action,” Hamburg said.
“…Our expectation is that companies will work to quickly and thoroughly to correct deficiencies and ensure safety. Companies must have a realistic expectation that if they are crossing the line, they will be caught, and if they fail to act, we will.”
Response timeframe
Under the Bush Administration, all warning letters were referred to the FDA’s Chief Counsel for review – a process that the agency now intends to limit to “significant legal issues” in order to speed the procedure.
Hamburg told reporters after her speech: “My own naïveté might help move the ball forward a bit because some of these timeframes just don’t seem acceptable to me.”
Under the new policy, if a company is found to be “significantly out of compliance”, it will have fifteen working days to respond before the FDA issues a warning letter or takes enforcement action.
She also emphasized the agency’s commitment to developing closer ties with local, state and international officials who may be able to act more quickly than the FDA in response to a public health risk. Although this is already the intention on a state and local level in terms of food safety, Hamburg mentioned that she met with European officials early in her tenure to discuss how safety standards could become more harmonized worldwide to reflect the globalized nature of the industry.