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FDA Expanded Access Proposals Too Narrow For Patient Advocates

Executive Summary

The Abigail Alliance's response to an FDA proposal on expanded access to investigational drugs suggests the patient advocacy group will continue to pursue legal action against the agency

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Expanded IND Access: FDA Seems Resolved, Leaving Many Questions For Firms

FDA seems set on implementing its proposed rules on patient access to investigational drugs despite industry-wide concern

Expanded IND Access: FDA Seems Resolved, Leaving Many Questions For Firms

FDA seems set on implementing its proposed rules on patient access to investigational drugs despite industry-wide concern

Access to investigational drugs

FDA aims to publish by October two final rules on related investigational drug issues, the HHS regulatory agenda discloses. One would clarify when it is appropriate to charge for a drug provided in a clinical trial (1"The Pink Sheet," Dec. 18, 2006, p. 18). The other would describe ways that patients may obtain investigational drugs for treatment use as part of expanded access programs (2"The Pink Sheet," Dec. 18, 2006, p. 12). While patient groups complain that FDA proposes to define expanded access too narrowly, insurers object to the possibility that much of the cost of drugs, which might newly have a price-tag, would be passed on to them (3"The Pink Sheet," March 26, 2007, p. 21). Discussion at a recent ODAC meeting revealed that FDA wants pharma to offer more expanded access programs, but firms worry they may be penalized if rare side effects occur from a drug provided by that avenue (4"The Pink Sheet," March 17, 2008, In Brief)

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