FDA Enforcement

Enforcement matters are a top priority for FDA and other government agencies, and therefore are a top priority for our practice as well. Our substantial government experience includes representation of clients in FDA, HHS, Office of Inspector General (OIG), Department of Defense and Department of Justice investigations and enforcement actions.

We defend clients before a variety of agencies and in court when necessary. We have a history of successfully defending clients in important complex criminal and civil cases, including federal and multi-state investigations on False Claims Act matters, kickbacks, off-label promotion and drug pricing.

We have an established track record of closely working with clients facing FDA enforcement actions – such as injunctions and product seizures. We coordinate closely with clients to effectively communicate to FDA headquarters and district offices the clients’ understanding of the agency’s compliance concerns. When appropriate, we counsel clients in developing corrective and preventative action plans. If litigation ensues, we vigorously defend the client. Indeed, our firm litigated the only Consent Decree in which FDA lifted the GMP application hold on pending product applications.

• California Court of Appeal Rules that Manufacturers of Brand-Name Prescription Drugs can be held Responsible for Negligently Failing to Warn of Side Effects Suffered by Users of Generic Equivalents
  November 12, 2008
• All Signs Point to Increased Scrutiny by FDA of Foreign Manufacturing Facilities: New GAO Report Criticizing FDA’s Foreign Inspection Program May Add Momentum
  October 31, 2008

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