3.0.0 931 2023-01-11T13:28:29Z 2023-01-11T13:28:29Z House HR 2015-02-12 114 [Congressional Record Volume 161, Number 24 (Thursday, February 12, 2015)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. DeLAURO:H.R. 931.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3 and Article I, Section 8,Clause 18 of the United States Constitution.[Page H1036]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2015-02-13T14:52:33Z Referred to 2015-02-12T15:06:45Z 2015-02-13 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2015-02-12 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2015-02-12 Introduced in House IntroReferral Intro-H 9 Library of Congress 2015-02-12 Introduced in House IntroReferral 1000 9 Library of Congress D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 N S000480 Rep. Slaughter, Louise McIntosh [D-NY-25] LOUISE SLAUGHTER D NY M. 25 2015-02-12 True M001188 Rep. Meng, Grace [D-NY-6] Grace Meng D NY 6 2015-02-12 True E000288 Rep. Ellison, Keith [D-MN-5] Keith Ellison D MN 5 2015-02-24 False G000551 Rep. Grijalva, Raúl M. [D-AZ-3] Raúl Grijalva D AZ M. 3 2015-02-24 False D000191 Rep. DeFazio, Peter A. [D-OR-4] PETER DEFAZIO D OR A. 4 2015-03-16 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2015-04-14 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2015-06-23 False Health Administrative law and regulatory procedures Administrative remedies Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health information and medical records Infectious and parasitic diseases Licensing and registrations Medical research Prescription drugs Health 00 2015-02-12 Introduced in House 2015-07-15T22:06:55Z Helping Effective Antibiotics Last Act of 2015 or the HEAL Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population.

A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy.

The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance.

Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes.

To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies.

The FDA must issue guidance on the development of target product profiles for antibacterial drugs.]]> HEAL Act Display Title HEAL Act Official Title as Introduced To provide for approval of certain drugs and biological products indicated for use in a well-defined population of patients in order to address increases in bacterial resistance to drugs and biological products, and for other purposes. Introduced in House IH Short Titles as Introduced HEAL Act Short Titles as Introduced Helping Effective Antibiotics Last Act of 2015 Introduced in House 2015-02-12T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114hr931ih/xml/BILLS-114hr931ih.xml 2015-02-13 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.