H.R.6514 - Cody Miller Initiative for Safer Prescriptions Act
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.
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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.CommentsClose CommentsPermalink
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.CommentsClose CommentsPermalink
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink
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:CommentsClose CommentsPermalink
‘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).CommentsClose CommentsPermalink
‘(b) Content- The regulations promulgated under subsection (a) shall require that the PMI with respect to a drug--CommentsClose CommentsPermalink
‘(1) be scientifically accurate and based on the professional labeling approved by the Secretary and authoritative, peer-reviewed literature; andCommentsClose CommentsPermalink
‘(2) includes nontechnical, understandable, plain language that is not promotional in tone or content, and contains at least--CommentsClose CommentsPermalink
‘(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;CommentsClose CommentsPermalink
‘(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;CommentsClose CommentsPermalink
‘(E) measures patients may be able to take, if any, to reduce the side effects and risks of the drug;CommentsClose CommentsPermalink
‘(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; andCommentsClose CommentsPermalink
‘(c) Timeliness, Consistency, and Accuracy- The regulations promulgated under subsection (a) shall include standards related to--CommentsClose CommentsPermalink
‘(1) performing timely updates of drug information as new drugs and new information becomes available;CommentsClose CommentsPermalink
‘(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; andCommentsClose CommentsPermalink
‘(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.CommentsClose CommentsPermalink
‘(1) SUBMISSION OF PMI FOR APPROVAL- The regulations promulgated under subsection (a) shall--CommentsClose CommentsPermalink
‘(A) with respect to any drug for which an application is submitted under subsection (b) or (j) of section 505 of this Act, or under subsection (a) or (k) of section 351 of the Public Health Service Act, on or after the date that is 18 months after the date of the enactment of the Cody Miller initiative for Safer Prescriptions Act--CommentsClose CommentsPermalink
‘(i) require the sponsor of the drug to submit PMI for the drug as part of such application; andCommentsClose CommentsPermalink
‘(ii) provide for approval or disapproval of the PMI as part of the process for approving or disapproving the application; andCommentsClose CommentsPermalink
‘(2) IDENTICAL PMI FOR GENERIC DRUGS- The regulations promulgated under subsection (a) shall require the PMI for a drug subject to an abbreviated new drug application under section 505(j) to be identical to the PMI for the listed drug (as such term is used in section 505(j)), except for excluding any portion of the PMI for the listed drug that is protected by patent or by an exclusivity period under this Act.CommentsClose CommentsPermalink
‘(1) IN GENERAL- 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.CommentsClose CommentsPermalink
‘(2) EFFECT OF SUBMISSION- If the sponsor of a drug submits PMI to such electronic registry, the sponsor is deemed, subject to the deadlines specified in subsection (d)(1), to have submitted the PMI for purposes of subsection (d)(1).’.CommentsClose CommentsPermalink
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).CommentsClose CommentsPermalink
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U.S. Congress - Text of H.R.6514 as Introduced in House Cody Miller Initiative for Safer Prescriptions Act
