FDA's Hamburg Talks Tough on Inspections, Enforcement, Warning Letters at FDLI Forum

Mark Mansour, Partner, Bryan Cave, LLP

FDA Commissioner Margaret A. Hamburg put industry on notice in a brief but well orchestrated rollout of FDA’s new enforcement policy.  The message, in Dr. Hamburg’s own words, is that “the FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible.”  On the job now for just shy of three months, Commissioner Hamburg addressed a group of industry representatives, attorneys, consumer representatives, and media at an August 6th event sponsored by the Food and Drug Law Institute in Washington, D.C.

Dr. Hamburg expressed concern about what she described as “unreasonable” delays in FDA enforcement actions in the recent past, and said that “serious violations have gone unaddressed for far too long.”  She observed that that the enforcement process is “too long and arduous when the public’s health is in jeopardy.”

Hamburg laid out a series of steps FDA intends to take, presumably starting immediately:

• Set post-inspection deadlines. The FDA will establish a clear timeline for regulated industry to respond to significant FDA inspection findings, generally giving no more than 15 days to respond to such findings before the agency issues a warning letter or takes other enforcement action.
• Take responsible steps to speed the warning letter process. The FDA will streamline the warning letter process by limiting review of warning letters by the Office of Chief Counsel to those that present significant legal issues.
• Work more closely with FDA’s regulatory partners. In some cases, such as with food safety issues, state, local, and international officials can act more quickly than the FDA. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.
• Prioritize follow-up on warning letters and other enforcement actions. The FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or major product recall occurs.
• Be prepared to take immediate action in response to public health risks. To better protect the public health, the agency is prepared to act more quickly and aggressively to deal with significant public health concerns and violations. Such actions may occur before a formal warning letter is issued.

Develop and implement a formal warning letter “close-out” process.  If the agency can determine that a firm has fully corrected violations raised in a warning letter the agency will issue an official “close-out” notice and post this information on the FDA Web site. This will be an important motivator for corrective action by manufacturers.

What Hamburg did not address is what will be done to streamline the approval process for medical devices and for other FDA-regulated products, nor did she address the persistent and growing problem of unqualified inspectors roaming plants armed with the authority to enforce.  No one disputes the need for vigorous, predictable enforcement, but FDA’s credibility is not threatened solely by the perception that it cannot keep the marketplace safe.  It is threatened as much by the reality that for those products that require pre-market approval, there is no end in sight to the delays and the absence of sufficient qualified technical staff to evaluate products and therapies and facilitate their release to the medical and patient community.  Ignoring that problem while focusing on regulating to the worst common denominator of the industry, by any a measure a very small minority, may make great headlines. Unfortunately, it leaves unaddressed some of FDA’s major deficiencies.

Mark Mansour is a partner in the firm, Bryan Cave, LLP