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

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

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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


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