Hogan Lovells Publications | Pharmaceutical and Biotechnology Alert | 22 October 2018

A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing

Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, M.D., recently indicated that the Food and Drug Administration (FDA) is unlikely to take enforcement action against a pharmaceutical company committing run-of-the-mill advertising violations, leaving competitors to "duke it out" among themselves.

As FDA's declining enforcement efforts will put increased pressure on firms to keep their competitors in line through litigation and other forms of private dispute resolution, we've summarized the legal options that might be available to an aggrieved company when FDA does not pursue enforcement action against a competitor engaging in false or misleading promotion or advertising or unfair competition.

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