H.R. 2592 would amend the Federal Food, Drug, and Cosmetic Act to provide for one or more Critical Path Public-Private Partnerships to implement the Critical Path Initiative of the Food and Drug Administration.
Detailed Summary
Safe and Effective Drug Development Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of the Food and Drug Administration (FDA) by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, and enhance medical product safety. Prohibits such an entity from accepting any funding for the technical programs of a Critical Path Public-Private Partnership from any individual or organization that manufactures, distributes, or sells any FDA-regulated product. Establishes an exception for accepting funds from a consortium of companies whose products are FDA-regulated if the Secretary determines that such acceptance would not result in any conflict of interest and issues a waiver.
Status of the Legislation
Latest Major Action: 6/6/2007: Referred to House committee. Status: Referred to the House Committee on Energy and Commerce.
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