3.0.0 6502 2019-11-15T21:18:14Z 2019-11-15T21:18:14Z House H HR 2012-09-21 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BILBRAY:H.R. 6502.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, To regulate Commerce with foreignNations, and among the several States, and with the IndianTribes; Congress has the authority under this section toregulate commerce and FDA products.[Page H6277]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-09-26T14:03:53Z Referred to 2012-09-21T13:03:20Z 2012-09-26 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-09-21 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-09-21 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-09-21 Introduced in House IntroReferral 1000 9 Library of Congress B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 N M000087 Rep. Maloney, Carolyn B. [D-NY-14] CAROLYN MALONEY D NY B. 14 2012-09-21 True D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2012-09-21 True Health Administrative law and regulatory procedures Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government information and archives Government studies and investigations Health information and medical records Intellectual property Medical research Prescription drugs Health 00 2012-09-21 Introduced in House 2012-11-29T20:15:48Z 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 Short Titles as Introduced Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 Display Title Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 Official Title as Introduced To amend title V of the Federal Food, Drug, and Cosmetic Act to provide for extensions of marketing exclusivity periods for drugs in certain combinations of such drugs, and for other purposes. Introduced in House 2012-09-21T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr6502ih/xml/BILLS-112hr6502ih.xml 2012-09-26 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.