August 5, 2015

Avoiding FDA Consent Decrees: Address Adverse Inspection Findings and Warning Letters

3 min

The Food and Drug Administration (FDA) is not an enforcement agency; it is a regulatory agency. And one of the important differences between the two is that FDA's interest is compliance, not enforcement. Consistent with FDA's being a regulatory agency, its typical pattern is to bring enforcement actions (e.g., actions for injunctive relief) only when its previous attempts to secure compliance have not been successful from FDA's perspective.

A recent enforcement action against a dietary supplement company illustrates this point. On August 4, 2015, FDA posted notice of the entry of a consent decree (permanent injunction) against a dietary supplement company based upon violations of good manufacturing practices. The consent decree was preceded by a warning letter in 2012 and subsequent inspections in 2013 and 2014, all involving the same types of issues.

The implication of this sequential approach, where initiation of an enforcement action follows other actions, is that FDA-regulated entities should address FDA concerns at the outset. Valid negative manufacturing plant inspection findings or alleged violations set forth in a warning letter should be taken seriously, addressed directly, and corrected, and should not be repeated. In addition, companies should document with great care their corrective actions and communicate them to FDA.

It is not enough for a company to think that it has addressed FDA's concerns; FDA needs to know what actions have been taken and be satisfied with the company's actions. The alternative increases the risk that problems cited in a warning letter two years ago will become the predicate and a substantial part of the rationale for subsequent, more aggressive, and, yes, more intrusive enforcement action.

If, for example, FDA cites a company for allegedly making unsupported therapeutic claims about a product, the company would be well advised to make a very thorough "scrub" of all of its marketing materials, including websites, and not restrict its response to only those materials cited in the warning letter. There is a risky tendency for companies to ignore the catch-all, seemingly boilerplate phrase at the end of all warning letters, which states that the instances cited are only representative of the agency's concerns and that other violations may exist that are not referenced. Addressing only the specific items in the warning letter can have disastrous consequences down the road. Moreover, the company should go further, and be transparent with FDA about the actions taken, including processes put in place to ensure ongoing compliance. Where possible, a company should seek to get at least tacit FDA acknowledgment of the appropriateness and legal sufficiency of the actions taken.

Companies assess the risks of their strategies on a regular basis. Risks must be calculated in light of adverse regulatory findings. Simply put, the risk of pushing the envelope increases after receipt of a warning letter. FDA's next step may not be another warning letter, but a less friendly "sign or sue" letter from the Department of Justice, accompanied by a draft proposed consent decree.

"Progressive discipline," a familiar concept in human resources and employment law, is a useful concept to keep in mind. The surest way for a company to avoid "step three," a significant FDA enforcement action, with all its attendant costs and consequences, is to solve the problem at "step one."