S.Amdt. 2128

1. Adds SEC. 9__. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION DRUGS at the end of title IX

   Adds a section

   In S. 3187 · Placed on Calendar Senate

   (b) Human Clinical Testing.--Section 5(b)(1)(A)(ii)) of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by striking "after the date such drug is designated under section 526 of such Act and".

   Inserted: SEC. 9__. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION DRUGS.

   Inserted: (a) Short Title.--This section may be cited as the "Cody Miller Initiative for Safer Prescriptions Act".

   Inserted: (b) Patient Medication Information for Prescription Drugs.--Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505E, as added by this Act, the following:

   Inserted: "SEC. 505F. PATIENT MEDICATION INFORMATION FOR PRESCRIPTION DRUGS.

   Inserted: "(a) In General.--Not later than 2 years after the date of enactment of this section, the Secretary shall issue regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (referred to in this section as 'PMI') for drugs subject to section 503(b)(1).

   Inserted: "(b) Content.--The regulations promulgated under subsection (a) shall require that the PMI with respect to a drug--

   Inserted: "(1) be scientifically accurate and based on the professional labeling approved by the Secretary and authoritative, peer-reviewed literature; and

   Inserted: "(2) includes nontechnical, understandable, plain language that is not promotional in tone or content, and contains at least--

   Inserted: "(A) the established name of drug, including the established name of such drug as a listed drug (as described in section 505(j)(2)(A)) and as a drug that is the subject of an approved abbreviated new drug application under section 505(j) or of an approved license for a biological product submitted under section 351(k) of the Public Health Service Act, if applicable;

   Inserted: "(B) drug uses and clinical benefits;

   Inserted: "(C) general directions for proper use;

   Inserted: "(D) contraindications, common side effects, and most serious risks of the drug, especially with respect to certain groups such as children, pregnant women, and the elderly;

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   Inserted: "(E) measures patients may be able to take, if any, to reduce the side effects and risks of the drug;

   Inserted: "(F) when a patient should contact his or her health care professional;

   Inserted: "(G) instructions not to share medications, and, if any exist, key storage requirements, and recommendations relating to proper disposal of any unused portion of the drug; and

   Inserted: "(H) known clinically important interactions with other drugs and substances.

   Inserted: "(c) Timeliness, Consistency, and Accuracy.--The regulations promulgated under subsection (a) shall include standards related to--

   Inserted: "(1) performing timely updates of drug information as new drugs and new information becomes available;

   Inserted: "(2) ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications in order to avoid patient confusion and harm; and

   Inserted: "(3) developing a process, including consumer testing, to assess the quality and effectiveness of PMI in ensuring that PMI promotes patient understanding and safe and effective medication use.

   Inserted: "(d) Electronic Repository.--The regulations promulgated under subsection (a) shall provide for the development of a publicly accessible electronic repository for all PMI documents and content to facilitate the availability of PMI.".

   Inserted: (c) Publication on Internet Website.--The Secretary of Health and Human Services shall publish on the Internet website of the Food and Drug Administration a link to the Daily Med website (http://dailymed.nlm.nih.gov/dailymed) (or any successor website).

   Original wording

   At the end of title IX, add the following:

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As printed