New program seeks to reduce misuse and adverse reactions by simplifying prescription labels.
After more than a decade of debate and discussion, FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products. A new one-page Patient Medication Information (PMI) guide would replace the more complex and lengthy Patient Package Inserts (PPIs) now distributed in pharmacies dispensing prescription medicines.1
The aim of the new program is to reduce drug misuse and adverse reactions by providing accurate information on product indications and uses to help people take prescription medicines safety and effectively, stated FDA commissioner Robert Califf in unveiling the new proposal May 30, 2023.2 Currently, the different types of information on prescription drugs as now required can be confusing and prompt patients to stop taking medications or to use them inappropriately, leading to treatment failures, hospitalizations, and even deaths.
Instead, the new rule would establish a one-page document that highlights essential information on product use and would be given to patients with their medications, including certain biological products provided in outpatient settings.3 The information also will be available online for public access. FDA anticipates that by reducing duplicative information, the new system will be more cost-efficient for drug and biotech manufacturers. The new format also will support translation of PMI to other languages and facilitate the use of technologies to convert the information to additional formats. FDA estimates that its proposal would cost about $20 million a year to implement, but would yield greater benefits and savings, largely from safer and more appropriate use of medicines.
To realize such gains, sponsors of new drugs will seek FDA approval of PPIs as part of new drug applications (NDAs) or biologics licensed applications (BLAs). In addition, manufacturers of already approved medicines will have to revise existing patient information documents and file supplemental applications to gain PMI approval. The greater burden on industry will involve updating systems for printing and packaging PMIs with medicines, an undertaking that has generated objections to previous FDA proposals for revising required information for patients. To facilitate these changes, the agency outlines a five-year implementation schedule, as it calculates that sponsors would have to submit labeling supplements for more than 2600 existing drugs and more than 1600 new drug applications.
Generic drug makers face added complexities in converting current medication information to the new format, as they will have to refer to new PMIs of their reference listed drugs, once those are submitted to and approved by FDA. The agency says it will facilitate this process by creating PMI templates for approved ANDAs if the reference drug has been withdrawn or lacks an approved PMI.
In recognition of the issues raised from past proposals, FDA requests comments from industry on the usefulness and appropriateness of this latest patient information plan, the accuracy of the agency’s estimate of the burden and cost of providing the requested information, ways to improve the PMI proposal, and strategies for a reducing the burden of collecting the requested information. Industry has six months to submit comments.