US Congress House Bill 6502 (Prior Session Legislation)

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Spectrum: Slight Partisan Bill (Democrat 2-1)
Status: Introduced on September 21 2012 - 25% progression, died in committee
Action: 2012-09-26 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to designate a combination of drugs as a significant drug combination if such combination: (1) includes two or more drugs or biological products that, when used in combination, offer the potential to significantly advance treatment for a serious or life-threatening disease and, in combination, meet the criteria for co-development of drug combinations in Food and Drug Administration (FDA) guidance; and (2) includes at least two drugs that are not approved. Requires the Secretary to develop, publish, and revise annually a list of combinations of two or more drugs designated as significant drug combinations. Extends the market exclusivity for a drug by six months if it is designated as a significant drug combination before it is approved as a new drug. Requires the Secretary to review and take action on a drug in a significant drug combination designated under this Act within six months after receiving an application for approval of a new drug application or licensure of a biosimilar biological product. Requires the Secretary, at the request of the sponsor of a drug, to expedite development and review for designated drug combinations. Requires the Secretary to establish an interagency task force to encourage the co-development of drugs in significant drug combinations. Requires the task force to develop, revise in response to public comments, and update annually a list of types of drug combinations it recommends that the Secretary designate as significant drug combinations. Directs the Secretary to study the impact of the extension of market exclusivity under this Act.

Life-Threatening Diseases Compassion through Combination Therapy Act of 2012

Rep. Brian Bilbray [R-CA]

Rep. Rosa DeLauro [D-CT]

Rep. Carolyn Maloney [D-NY]

Date	Chamber	Action
2012-09-26	House	Referred to the Subcommittee on Health.
2012-09-21	House	Referred to the House Committee on Energy and Commerce.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/6502/all-info
Text	https://www.congress.gov/112/bills/hr6502/BILLS-112hr6502ih.pdf