II 112th CONGRESS 2d Session S. 3212 IN THE SENATE OF THE UNITED STATES May 22, 2012 Mrs. Gillibrand introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication Information to ensure patients receive consistent and high-quality information about their prescription medications and are aware of the potential risks and benefits of prescription medications.

1.

Short title

This Act may be cited as the Cody Miller Initiative for Safer Prescriptions Act.

2.

Patient medication information for prescription drugs

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505D the following:

505E.

Patient medication information for prescription drugs

(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). (b)

Content

The regulations promulgated under subsection (a) shall require that the PMI with respect to a drug— (1)be scientifically accurate and based on the professional labeling approved by the Secretary and authoritative, peer-reviewed literature; and (2)includes nontechnical, understandable, plain language that is not promotional in tone or content, and contains at least— (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; (B)drug uses and clinical benefits; (C)general directions for proper use; (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; (E)measures patients may be able to take, if any, to reduce the side effects and risks of the drug; (F)when a patient should contact his or her health care professional; (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 (H)known clinically important interactions with other drugs and substances. (c)

Timeliness, consistency, and accuracy

The regulations promulgated under subsection (a) shall include standards related to— (1)performing timely updates of drug information as new drugs and new information becomes available; (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 (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. (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.

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3.

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).