FDA proposes long-awaited patient medication information rule

The US Food and Drug Administration (FDA) has proposed new drug labeling requirements to make it easier for patients to understand their medication while improving prescription adherence. The agency also argues that the rule will save manufacturers and regulators both time and resources.

FDA proposed a new rule on 30 May that would require manufacturers to publish a one-page Patient Medication Information (PMI) for their prescription drugs, certain biologics, and blood and blood components given in outpatient settings. The proposed rule is being issued more than a decade after the agency first began looking into developing such a requirement.

“Patient Medication Information would provide patients with clear, concise, accessible, and useful written information for prescription drugs and certain biological products and would be delivered in a consistent and easy-to-understand format to help patients use their prescription drug and certain biological products safely and effectively,” said FDA Commissioner Robert Califf. “Patient Medication Information's consistent formatting may help facilitate translations to other languages and make it easier for artificial intelligence or other technologies to convert the information, where feasible, to formats that assist the visually impaired.”

Under current regulations, patients often receive more than one type of written patient information such as patient package inserts (PPIs), Medication Guides, consumer medication information (CMI) and Instructions for Use documents.

“This written patient information, in certain instances, has been duplicative, incomplete, conflicting, or difficult to read and understand, and has not been sufficient to meet the needs of patients,” said FDA. “PMI is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.”

If the rule is finalized as is, new drug application (NDA) and biologics license application (BLA) sponsors would be required to submit a proposed PMI for outpatient settings that would include the product name, a concise summary of the product’s indication and use, safety information, common side effects, and directions for use as part of their premarket application. If their product is approved, it would need to also include the approved PMI.

Sponsors of approved abbreviated new drug applications (ANDAs) will also need to use approved PMIs by referring to the PMIs of their reference listed drug (RLD) that has an approved PMI from FDA. The agency says it will also create PMI templates for approved ANDAs if the ANDA references a listed drug whose approval has been withdrawn or if no PMI was approved for the RLD before its approval was withdrawn.

FDA says PMIs will be stored in an online database which will be publicly available. The agency says authorized dispensers will be required to provide PMIs to patients and by default they will be required to give out the paper-version of the PMI, though patients may request only a digital version of the document.

Companies that provide blood transfusions and blood components may be able to get a waiver from providing PMIs under the proposed rule.

“The requirement to create PMI and make it available for distribution to transfusion services applies to all establishments that collect blood and blood components for transfusion,” said FDA. “However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

“Each time blood or blood components are administered on an outpatient basis, transfusion services would be considered authorized dispensers and would be required to provide PMI to each patient,” the agency added. “This approach would ensure that every patient who receives blood or a blood component with an associated PMI on an outpatient basis would receive that PMI.”

As proposed, the rule would take effect five years after it is finalized. FDA would withdraw its current regulatory requirement for sponsors to provide Medication Guides for certain prescription drug products and PPIs for oral contraceptives and estrogen-containing products.

If the rule goes into effect, FDA says there would be added cost to the agency and industry primarily because manufacturers would have to develop PMIs, and the agency would have to review and approve them. While the cost of implementing the rule could go into the hundreds of millions of dollars, the eventual savings could be in the billions of dollars, according to the agency’s accounting.

In addition to reducing costs and improving patient understanding of drugs they take, FDA says the rule could help it fight misinformation and disinformation about medical products. (RELATED: Califf, past FDA chiefs look for partners to curb misinformation, Regulatory Focus 9 January 2023)

“Having ready access to direct and easy to understand information in a consistent format for prescription drugs and certain biological products may reduce instances of both accidental and purposeful misinterpretations,” Califf said. “Today's proposed rule is a practical step towards improving the nation's health. Our public health mission is to ensure drugs and certain biological products are used safely and effectively, help people feel empowered and confident in their ability to manage their care, and prevent negative health outcomes.”

Stakeholders can comment on the proposed rule until 26 November on www.regulations.gov under docket no. FDA-2019-N-5959.

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FDA proposes long-awaited patient medication information rule

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