S.3212 - Cody Miller Initiative for Safer Prescriptions Act

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. view all titles (2)

All Bill Titles

  • Official: 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. as introduced.
  • Short: Cody Miller Initiative for Safer Prescriptions Act as introduced.

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05/22/12
 
 
 
 
 
 
 

Official Summary

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 informat

Official Summary

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.

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