Increased FDA Regulatory Action: The Current Landscape and Its Impact on Drug and Medical Device Litigation


The Food and Drug Administration (FDA) has a number of tools to enforce its laws and regulations. From warning and untitled letters to seizures, recalls, injunctions, monetary penalties and criminal prosecutions, its options are quite varied. Over the last few years, however, FDA has significantly increased its use of these regulatory tools, reemphasizing its commitment to “prevent harm to the American people” through effective enforcement of FDA regulations.

Every indication suggests this pattern will only continue to increase in the future. This renewed emphasis on enforcement will invariably impact all industries regulated by FDA. As a result, it is important for drug and medical device companies to be aware of this refocused regulatory landscape and understand how these changes may impact them.

Specifically, since August 2009, FDA has enhanced its regulatory efforts by, among other things:

- Expediting the issuance of warning letters to companies by limiting the FDA chief counsel’s review to circumstances where “significant legal issues” are present;

- Accelerating enforcement actions by eliminating the need to issue multiple warning letters to noncompliant firms before taking action;

- Increasing the funding necessary for additional inspection and compliance activities;

- Setting post-inspection deadlines of, in general, no more than 15 working days for a company to respond before moving forward with a warning letter or enforcement action;

- Emphasizing its intention to increase the use of misdemeanor prosecutions to hold corporate officials personally accountable for corporate actions; and

- Implementing the “Bad Ad” program to help healthcare providers recognize misleading prescription drug promotions and provide them with an easy way to report this activity to the Agency.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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