S. 3212 (112th): Cody Miller Initiative for Safer Prescriptions Act

Introduced:
May 22, 2012 (112th Congress, 2011–2013)
Sponsor:
Sen. Kirsten Gillibrand [D-NY]
Status:
Died (Referred to Committee)
See Instead:
This bill was re-introduced as S. 752 on Apr 17, 2013. See S. 752 for current action on this subject.

The bill’s title was written by the bill’s sponsor. S. stands for Senate bill.

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Status

This bill was introduced on May 22, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced May 22, 2012
Referred to Committee May 22, 2012
Cosponsors
none
Committees

Senate Health, Education, Labor, and Pensions

The committee chair determines whether a bill will move past the committee stage.

Full Title

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.

Summary

No summaries available.

Text

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Last updated May 22, 2012.
4 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

5/22/2012--Introduced.
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs.
Requires such regulations to require the PMI for such a drug:
(1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and
(2) to include plain language that is not promotional in tone or content.
Requires that such language include:
(1) the established name of the drug;
(2) drug uses and clinical benefits;
(3) general directions for proper use;
(4) contraindications, common side effects, and the most serious risks of the drug;
(5) measures patients may take to reduce the side effects and risks;
(6) when a patient should contact his or her health care professional;
(7) instructions not to share medications;
(8) any key storage requirements;
(9) recommendations relating to proper disposal of any unused portion of the drug; and
(10) known clinically important interactions with other drugs and substances.
Requires such regulations to:
(1) include standards related to performing timely updates of drug information, ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications, and developing a process to assess the quality and effectiveness of PMI in promoting patient understanding and safe and effective use; and
(2) provide for the development of a publicly accessible electronic repository for all PMI. Requires the Secretary to publish on the Food and Drug Administration (FDA) website a link to the Daily Med website.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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