3.0.0 2214 2023-01-11T13:29:30Z 2023-01-11T13:29:30Z Senate S 2015-10-28 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2015-10-28T16:02:56Z 2015-10-28 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-10-28 Introduced in Senate IntroReferral 10000 9 Library of Congress G000555 Sen. Gillibrand, Kirsten E. [D-NY] Kirsten Gillibrand D NY E. N W000817 Sen. Warren, Elizabeth [D-MA] Elizabeth Warren D MA A. 2015-10-28 True S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI 2015-10-28 True B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2015-10-28 True B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2015-10-28 True Health Administrative law and regulatory procedures 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 Prescription drugs Health 00 2015-10-28 Introduced in Senate 2015-11-05T16:21:39Z Cody Miller Patient Medication Information Act

This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Food and Drug Administration (FDA) to regulate the authorship, content, format, and dissemination of patient medication information for prescription drugs. (Patient medication information includes the instructional brochures provided to patients when a prescription is filled.)

FDA regulations must require drug patient medication information to be scientifically accurate, to be based on the approved professional labeling, and to include plain language that is not promotional in tone or content and that provides specified information including drug uses and side effects.

The regulations must include standards for: (1) timely reviews and updates of patient medication information, (2) updates to help communicate information that is shared by similar drugs, and (3) assessing the effectiveness of patient medication information in promoting patient understanding and safe and effective use of medications. The FDA must develop a public electronic repository for all patient medication information.

When a prescription drug is sold or dispensed, patient medication information must be provided.

]]> Cody Miller Patient Medication Information Act Display Title Cody Miller Patient Medication Information Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to require patient medication information to be provided with certain prescription drugs. Introduced in Senate IS Short Titles as Introduced Cody Miller Patient Medication Information Act Introduced in Senate 2015-10-28T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2214is/xml/BILLS-114s2214is.xml 2015-10-28 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.