Bill113th Congress

H.R. 1608

Cody Miller Initiative for Safer Prescriptions Act

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Introduced
Apr 17, 2013
Origin Chamber
House
Policy Area
Health
Latest Action
Apr 19, 2013

Sponsor

Rep. Owens, William L. [D-NY-21]

Democrat·NY-21
Bioguide ID: O000169
First Name: William
Middle Name: L.
Last Name: Owens
By Request: N
0
Cosponsors
1
Committees
4
Actions
0
Amendments
1
Related Bills
7
Subjects
1
Summaries
3
Titles
1
Text Versions

Bill Details

Update Date
Nov 15, 2019
Origin Chamber
House
Bill Type
HR
Bill Number
1,608
Congress
113
Introduced Date
Apr 17, 2013
Policy Area
Health
Is Law
No
Apr 19, 2013Committee

Referred to the Subcommittee on Health.

Source: House committee actions

Apr 17, 2013IntroReferralH11100

Referred to the House Committee on Energy and Commerce.

Source: House floor actions

Apr 17, 2013IntroReferralIntro-H

Introduced in House

Source: Library of Congress

Apr 17, 2013IntroReferral1000

Introduced in House

Source: Library of Congress

Introduced in House· Apr 17, 20130

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.

Energy and Commerce Committee

House· Standing
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesHealth information and medical recordsPrescription drugs

Introduced in House

Apr 17, 2013

Cody Miller Initiative for Safer Prescriptions Act — Informed