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.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1608 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 1608
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 17, 2013
Mr. Owens introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Cody Miller Initiative for Safer
Prescriptions Act''.
SEC. 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:
``SEC. 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.''.
SEC. 3. PUBLICATION ON INTERNET WEB SITE.
The Secretary of Health and Human Services shall publish on the
Internet Web site of the Food and Drug Administration a link to the
Daily Med Web site (http://dailymed.nlm.nih.gov/dailymed) (or any
successor Web site).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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