FDA Patient Medication Information Highlighted

Attorneys Dominick DiSabatino and Cortney Inman (SheppardMullin) say FDA appears to have two goals for its recently announced proposed rule to require manufacturers to provide a one-page Patient Medication Information (PMI) for each drug prescribed. The goals, they say, are:

• standardization of patient-facing prescription drug product labeling; and
• expanding access to essential safety and efficacy information relevant to such medications.

Writing in an online blog post, the attorneys say the proposal is no surprise to those who have followed the agency’s decades-long search for the most appropriate manner of conveying prescription medication information to patients. They describe the current four categories of written patient prescription drug information — the Patient Package Insert, Medication Guides, Consumer Medication Information, and Instructions for Use.

“The agency views these options as failed experiments in ensuring patients are using medications safely and effectively,” the post says. “For example, the agency noted that ‘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.’”

The attorneys give an overview of the proposal, noting that FDA identified the one-page requirement as one of the most important specifications of the proposed rule. They say the agency intended to provide little leeway for exemption from the one-page requirement and emphasized that although waivers will be available for some specifications, it anticipates “rarely granting a waiver to the one-page format requirement.”

NDA and BLA manufacturers will be required to obtain FDA approval for their PMI and ANDA manufacturers would either provide PMI that mirrors the reference-listed drug upon which its approval is based or an FDA-provided PMI template for the generic drug.

Although FDA expects there may be some extra costs incurred in the development and approval of PMIs, DiSabatino and Inman say the overarching benefit to manufacturers is that the rule provides clarity on what information they will need to prepare product labeling and customer-facing documents that help explain the product. “Additionally,” they say, “it is hoped that this rule will help to shed light on what FDA considers essential information that must be disclosed to the patient. This could be especially beneficial for manufacturers of specialty medications, as the new rule will provide a more straightforward way to navigate this process.”

The authors say they look forward to the notice and comment period to see how the agency weighs in on industry concerns and how the final rule and regulations ultimately take shape. They do not address the reason FDA’s original mandatory patient drug information proposal was defeated: retail pharmacy opposition joined by the incoming Reagan Administration. Comments on the proposed rule are due by 11/27.