H.R. 6514 (112th): Cody Miller Initiative for Safer Prescriptions Act

Introduced:
Sep 21, 2012 (112th Congress, 2011–2013)
Sponsor:
Rep. Christopher Gibson [R-NY20]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

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Status

This bill was introduced on September 21, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced Sep 21, 2012
Referred to Committee Sep 21, 2012
Cosponsors
1 cosponsors (1D) (show)
Committees

House Energy and Commerce

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

Full Title

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 Sep 21, 2012.
6 pages

Primary Source

View on THOMAS (The Library of Congress)

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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.

9/21/2012--Introduced.
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) 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;
(2) require the sponsor of a new drug or biological product to submit PMI as part of the new drug or abbreviated (generic) new drug application and provide for approval or disapproval of the PMI as part of the application process;
(3) require the sponsor of any drug lawfully marketed in the United States to submit PMI for the drug to the Secretary for approval or disapproval of the PMI;
(4) require the PMI for a generic drug to be identical to the PMI for the listed drug, except for excluding any portion of such PMI that is protected by patent or an exclusivity period under FFDCA; and
(5) 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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United States Code

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