FDA Civil Monetary Penalties Increase Across the Board to Keep Pace with Inflation

The FDA’s civil monetary penalties are increasing to adjust for inflation at under 2 percent.

Penalties for violating requirements for post-marketing studies, clinical trials, labeling or Risk Evaluation and Mitigation Strategies increased to nearly $290,000. The same penalty also applies to REMS violations that continue in the 30 days after receiving a written notice.

False or misleading direct-to-consumer advertising will also incur fines of almost $290,000, with subsequent violations in a three-year period drawing penalties of more than $578,000. Meanwhile, the penalty for failure to follow an order to recall a biologic increased to more than $219,000 per day.