Food and Drug Administration's Compliance With the Inflation Adjustment Act

GAO-02-933R: Published: Aug 1, 2002. Publicly Released: Aug 1, 2002.

Additional Materials:


J. Christopher Mihm
(202) 512-6082


Office of Public Affairs
(202) 512-4800

The Federal Civil Penalties Inflation Adjustment Act of 1990 requires each federal agency to issue a regulation adjusting its covered maximum civil monetary penalties for inflation by October 23, 1996, and requires them to make necessary adjustments at least once every 4 years thereafter. The Food and Drug Administration's Office of the Chief Counsel indicated that at least 14 of the agency's civil penalties are covered by the act, but the agency had not adjusted any of them for inflation.

Recommendation for Executive Action

  1. Status: Closed - Implemented

    Comments: On December 1, 2003 (68 FR 67094), FDA published a proposed rule identifying 14 civil penalties to be adjusted under the Inflation Adjustment Act. In commenting on the proposed rule, GAO pointed out that FDA had miscalculated the increases for several penalties and that the correct amounts should be higher. On July 20, 2004 (69 FR 43299), FDA published the final rule adjusting its maximum civil monetary penalties in compliance with the Inflation Adjustment Act. In the final rule, FDA agreed with GAO's comment and revised the calculation of its penalty amounts accordingly.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to initiate a regulatory action to adjust for inflation all of the agency's civil penalties that are covered by the Inflation Adjustment Act.

    Agency Affected: Department of Health and Human Services


Explore the full database of GAO's Open Recommendations »

Nov 21, 2017

Nov 20, 2017

Nov 8, 2017

Oct 31, 2017

Oct 26, 2017

Oct 17, 2017

Oct 12, 2017

Oct 11, 2017

Oct 10, 2017

Looking for more? Browse all our products here