FDA Civil Monetary Penalties Increase with Inflation

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

The maximum of aggregated penalties for all violations related to devices in a single proceeding increased to $1.8 million.

Penalties for violating requirements for post-marketing studies, clinical trials, labeling or Risk Evaluation and Mitigation Strategies increased to nearly $290,000.

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.

Any individual convicted of bribery, destroying documents, or of obstructing an investigation would be subject to a penalty over $426,000. In cases involving more than one individual, the fine will exceed $1.7 million.

The penalty for a supplier that knowingly and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made is increased to more than $15,000.

The new penalties — adjusted for inflation at just over 1.6 percent — apply to all future fines for violations that occurred since Nov. 2, 2015.

The HHS final rule updating civil monetary penalties is available here: www.fdanews.com/02-02-17-HHSMonetaryPenalties.pdf. — Conor Hale