by Steven Shapiro, Esq., and Linda Dougherty, Esq.
In an address before the Food and Drug Law Institute (FDLI) in Washington on Aug. 6, 2009, FDA’s newly-appointed commissioner, Margaret Hamburg, M.D., outlined the agency’s new enforcement strategy and her plan for creating “a strong FDA.”
According to Hamburg, who was sworn-in as FDA commissioner in May 2009, a strong FDA is one that enforces the law. Although she did not herself directly describe FDA’s recent enforcement history as ineffective, she briefly referenced statements from the Government Accountability Office (GAO) and other reports that have suggested “a steep decline in the FDA’s enforcement activity over the past several years.” She added FDA’s enforcement activities have been “hampered by unreasonable delays” in recent years and that “the pathways for enforcement action can be too long and arduous when the public's health is in jeopardy.”
To achieve more effective enforcement, she said, FDA must be more vigilant in following up on reported issues and in conducting regular inspections so that problems may be identified and resolved in their early stages. Additionally, FDA’s responses to violators must be strategic, for instance, through the use of “meaningful penalties” that will serve to deter future violations. FDA’s responses must also be made visible by publicizing enforcement actions, as well as the rationale behind them, to industry and consumers. Finally, FDA must be able to respond more quickly when the public health is at risk. Having stated these general elements of effective enforcement, she then outlined six specific initial policy and procedural changes FDA will take toward that goal:
Post-Inspection Response Deadline: Effective Sept. 15, 2009, there will be an established timeframe for the submission and agency review of responses to inspectional observations listed in a form FDA 483. Formerly, FDA’s receipt and review of such responses has tended to delay the issuance of a warning letter. Going forward, however, FDA will not delay the issuance of a warning letter in order to review a post-inspectional response that was received more than 15 business days after the issuance of the FDA 483. The establishment of this 15-day timeframe is expected to aid FDA in the timely issuance of warning letters and to promote prompt corrective actions in response to inspections.
An Accelerated Warning Letter Process: The process by which FDA issues warning letters will be streamlined, and thereby accelerated, by a new policy that will limit the Office of Chief Counsel’s review of warning letters to those presenting “significant legal issues.” Industry should expect a significant increase in the number of warning letters issued by FDA as a result of this new policy.
Coordination with Other Regulatory Entities: FDA will work more closely with its “regulatory partners” at the local, state, and international levels, which, in many cases, have the authority to act more quickly or with greater enforcement power than FDA in response to certain public health risks, such as food safety issues. Communication and coordination with other regulatory entities will allow for a rapid regulatory response.
Systematic Follow-up after Enforcement Actions: FDA will promptly follow up on warning letters, enforcement actions and product recalls, to assess the corrective actions taken by noncompliant firms. Such follow-up actions may include inspections and investigations. Too often in the past, FDA has either failed to follow up or allowed matters to linger for long periods of time as companies engaged in prolonged negotiations with the agency.
Immediate Action in Response to Significant Risks: FDA will be prepared to take immediate enforcement action—even before the issuance of a formal warning letter—in the face of significant public health concerns and violations. In such situations, enforcement actions will no longer be preceded by multiple warning letters. As an example of this new policy in practice, consider the immediate action taken by FDA in response to reports that Zicam intranasal zinc products may cause a loss of sense of smell. FDA issued a warning letter to Zicam, but rather than await a response before taking action, FDA also issued a Public Health Advisory the same day, warning the public not to use these products.
A Formal Warning Letter “Close-Out” Process: In the event that FDA determines a formerly noncompliant firm has fully addressed all violations listed in a warning letter, FDA will issue a “close-out” notice to that firm. Such notices will be placed on the public record and posted on FDA’s Web site. The availability of this public close-out status is expected to motivate prompt corrective action and provide a major incentive for companies to complete the process as quickly as possible.
