PhRMA Seeks Waivers on Patient Medication Info
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should take a more flexible approach to implementing its proposed rule on patient medication information (PMI) by waiving the one-page format requirement when needed to include key information in a drug’s PMI. “Although complying with this strict page limitation will be feasible for some products, our members anticipate that it will not be possible to adequately convey important information for many products and categories of products, such as those with complex safety profiles, multiple indications, or that are used in combination with other products (or are combination agents themselves),” the group says in comments to the agency.
“We understand FDA’s reasoning for setting the one-page limit, but applying this requirement broadly for all drugs within the proposed rule’s scope would unduly constrain the information that can be communicated to patients by emphasizing a PMI’s form over its function,” PhRMA says. The one-page format requirement is the “limitation driving other requirements” proposed by the agency (e.g., multiple PMIs for a single drug), and the proposal runs the risk of confusing patients, or contribute to them disregarding patient labeling altogether, but could also pose significant operational challenges at the point of care, it says.
PhRMA says FDA should provide guidance on how dispensers can provide PMI to patients electronically and should also explore novel electronic methods for disseminating the information. “Providing PMI to patients electronically would address many of the challenges with ensuring that patients receive the correct and most up-to-date version of a drug’s PMI, and the agency should provide more guidance about how dispensers can do so,” it says. “In addition, PhRMA strongly agrees with FDA’s objective of accommodating technological advances in how the PMI requirement is designed and implemented. Technology offers novel ways for patients to access PMI in a more seamless and convenient manner, and we urge FDA to explore these other methods.”
Additionally, PhRMA says FDA should extend the implementation schedule for the final rule and issue guidance on its implementation. The group says the effort will “require a sustained multi-year commitment of resources by all parties to ensure FDA approval of proposed PMIs and also to address downstream logistics for each drug with a new PMI (e.g., any implications for drug packaging). We have serious concerns in particular about the proposed implementation timeline’s feasibility for applicants with a substantial number of products requiring not only the development of PMIs for agency approval but also implementation of the newly approved PMIs.”