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Phase IV contract offered in FDA proposal as alternative to civil money penalties.

This article was originally published in The Tan Sheet

Executive Summary

PHASE IV CONTRACT OFFERED BY FDA AS ALTERNATIVE TO CIVIL MONEY PENALTIES was floated on Capitol Hill the week of June 30. The draft proposal developed by FDA and its supporters would make drug sponsors that fail to comply with Phase IV post-marketing obligations subject to a court order to meet their commitments. Sen. Edward Kennedy (D-Mass.) has been pushing for post-marketing enforcement to be included in the FDA reform bill (S 830), but his civil money penalty proposal was defeated in mark-up by the Labor & Human Resources Committee. FDA presented its proposal in recent meetings with industry, patient groups and congressional staff.
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