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)

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 (Also see "Clinical Trials Can Charge For Using Competitor Drugs Under FDA Proposed Rule" - Pink Sheet, 18 Dec, 2006.), p. 18). The other would describe ways that patients may obtain investigational drugs for treatment use as part of expanded access programs (² (Also see "FDA Expanded Access Proposals Too Narrow For Patient Advocates" - Pink Sheet, 18 Dec, 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 , 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).