Sec. 3. Patient medication information for prescription drugs
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Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 505F ( 21 U.S.C. 355g ) the following: The Secretary shall issue regulations on the patient medication information that is required to be in the printed labeling of drugs subject to section 503(b)(1), including regulations regarding the authorship, content, format, color, printing, and dissemination requirements for such patient medication information. The Secretary shall issue final regulations pursuant to the preceding sentence not later than 1 year after the date of enactment of this section. The regulations promulgated under subsection
(a)shall require that the patient medication information with respect to a drug— be scientifically accurate, include relevant patient safety information, and be approved by the Secretary; include understandable plain language, and include graphics and pictures when applicable, and be provided in a consistent, standardized format and color for all drug products, and not be promotional in tone or content, and contain at least— the established name of the drug (or, if the drug is a biological product, the proper name of the biological product) and the national drug code for the drug; indications for use approved by the Food and Drug Administration; general directions for proper use; contraindications, warnings, precautions, the most frequently occurring adverse reactions, and adverse reactions that are important for other reasons (such as because they are serious), especially with respect to certain subpopulations such as children, pregnant women, and the elderly; measures patients may be able to take, if any, to reduce the side effects and risks of the drug; information about when a patient should contact his or her health care professional; instructions not to share medications, and, if applicable, key storage requirements and recommendations relating to proper disposal of any unused portion of the drug; known clinically important interactions with other drugs, food, and other substances; a statement of whether sufficient data are available concerning the use of the drug in specified subpopulations, such as women, pregnant women, lactating women, women and men of reproductive age, and pediatric, geriatric, racial, and ethnic minority groups; the name of the manufacturer and a toll-free telephone number for consumers to contact the manufacturer of the drug; and a current link to Form FDA 3500B for voluntary reporting for consumers of adverse events, product problems, and product use errors (or any successor form); and be provided to a patient or agent of a patient in a printed format with each prescription dispensed, such that a drug labeled for distribution shall be accompanied by printed labeling physically on or within the packaging from which the drug is to be dispensed, in an adequate supply of printed patient medication information to accommodate prescriptions dispensed therefrom. The regulations promulgated under subsection
(a)shall— provide for timely reviews, approvals, and updates of patient medication information as new drugs and new information become available; provide for updates when appropriate to help communicate information that is shared by similar products or drugs within classes of medication to avoid patient confusion and harm; include specifications for language, graphics, format, color, and pictures required by subsection (b)(2), to be developed based upon documented patient research with one or more actual drug products that demonstrates improved patient learning and understanding of safe and effective medication use; and be based on a demonstrated causal connection between the enhanced patient medication information required by the regulations and improved patient medication adherence and compliance for the purpose of reducing the cost of health care and improving desired medical outcomes. . Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) is amended by adding at the end the following: If it is a drug subject to section 503(b)(1) and patient medication information is not provided in accordance with section 505G. .
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