Clinical Trials Can Charge For Using Competitor Drugs Under FDA Proposed Rule
Executive Summary
Clinical trial sponsors are permitted to charge for approved drugs obtained from competitors while conducting a clinical study evaluating an investigational drug under an FDA proposed rule
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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)
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)
Outcome Of Abigail Alliance Case May Be Moot Due To Marketplace Issues
Regardless of whether a federal appeals court determines that patients have a fundamental right to experimental therapy, it appears a host of potential problems in the marketplace will stymie increased access to such therapies in practice