Disgorgement Offers "Innovative Approach" To GMP Compliance - FDA
This article was originally published in The Gray Sheet
Executive Summary
FDA will look to recover profits from companies as a penalty for regulatory violations even in cases not involving the future sales of products deemed medically necessary.
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Disgorgement
Federal Trade Commission is requesting comments by March 1 on the use of disgorgement as a remedy for violations of the Hart-Scott-Rodino Act, the FTC Act and the Clayton Act. FDA has sought the recovery of profits as a compliance tool in the past and said it might consider them in cases not involving the future sales of products deemed "medically necessary" ("1The Gray Sheet" July 2, 2001, p. 9). In a November 1999 consent agreement with the agency, Abbott agreed to pay a $100 mil. civil money penalty related to GMP violations at a diagnostics production facility, and rather than cease production of tests considered medically necessary, to hand over 16% of the revenues generated by those products. For further information, contact John Graubert, Office of General Counsel, FTC, at (202) 326-2186...
Disgorgement
Federal Trade Commission is requesting comments by March 1 on the use of disgorgement as a remedy for violations of the Hart-Scott-Rodino Act, the FTC Act and the Clayton Act. FDA has sought the recovery of profits as a compliance tool in the past and said it might consider them in cases not involving the future sales of products deemed "medically necessary" ("1The Gray Sheet" July 2, 2001, p. 9). In a November 1999 consent agreement with the agency, Abbott agreed to pay a $100 mil. civil money penalty related to GMP violations at a diagnostics production facility, and rather than cease production of tests considered medically necessary, to hand over 16% of the revenues generated by those products. For further information, contact John Graubert, Office of General Counsel, FTC, at (202) 326-2186...
FDA Seeks Civil Money Penalties From Worldwide Medical, Firm's Executives
FDA affirmed its regulatory authority over home-use drugs-of-abuse assays in an October 1999 letter to Worldwide Medical that preceded its recent civil money penalty action against the firm, FDA reports.