PDMA Civil Monetary Penalties Increase 10% Under FDA Final Rule
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA increases fines based on Federal Civil Penalties Inflation Adjustment Act. The agency also increases penalties for violations to Generic Drug Enforcement Act and Childhood Vaccine Injury Act by 10%.
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FDA will increase maximum fines by 10% for civil violations under the Prescription Drug Marketing Act. The increase in maximum civil monetary penalties is determined by a formula in the Federal Civil Penalties Inflation Adjustment Act, FDA said in a 1 final rule published in the July 20 Federal Register. After FDA issued the 2 proposed rule Dec. 1, 2003, the agency received comments calling for larger increases in fines. However, the civil penalties act limits increases to 10% for each readjustment. The 10% increase represents .6% annual inflationary growth since PDMA maximum penalties were established in 1988. FDA also increased Generic Drug Enforcement Act penalties (set in 1992) and National Childhood Vaccine Injury Act penalties (set in 1986) by 10%. The final rule contains some technical revisions, including omitted medical device fines and correction of rounding errors. - Benjamin Lum |