FDA Guidance: Rulemaking for Patient Medication Information

The FDA has issued a final guidance for the presentation of quantitative efficacy and risk information for pharmaceutical direct-to-consumer (DTC) advertising, but this is only one of two recent developments in the agency’s approach to information presented to patients. The FDA has also proposed a new requirement for patient medical information that when combined with the new guidance seems to suggest a renewed interest in regulating how prescription drug information is presented to patients.

The quantitative information guidance includes pharmaceuticals for both human and veterinary use as well as therapeutic biologics, but the scope of the guidance does not include determinations of whether the advertising or promotional material is truthful and non-misleading. The FDA stated that it has seen an increase in quantitative presentations of both efficacy and risk information in DTC promotional materials over the past few years, which is often more intelligible to consumers and patients than qualitative information.

The guidance recommends that quantitative information for the control group in a clinical trial be presented along with information from the treatment group. The FDA also recommends that data on efficacy and risk probabilities be presented in both absolute frequencies and as percentages, which may aid the individual in properly interpreting the presented data. Conversely, the guidance states that consumers and patients typically do not understand relative frequencies as readily as they do absolute frequencies, and consequently relative frequency data might be omitted unless paired with information on absolute frequencies.

The FDA states that the media selected for presentation of quantitative information can affect the appropriateness of that information. Two related considerations are the amount of space and the amount of time the information is visible, depending on the medium. Sponsors should strive to provide a consistent format for data presented in advertising and promotional materials, but promotional materials should avoid presenting low-probability risks as seemingly insignificant risks by highlighting the low probability of that risk.

Prior to the issuance of the final guidance for quantitative DTC information, the FDA released a statement on the patient medication information (PMI) proposal, which would amend the regulations for prescription drug labeling. The May 30, 2023, PMI proposal would help rectify the fact that patients may receive more than one type of written information for a prescription drug or therapeutic biologic product, which studies have indicated can be confusing and in some cases, may conflict with other information given to the patient.

This problem can lead to patient frustration with the lack of clarity, which may lead patients to fall out of adherence with their pharmaceuticals, a problem thought to lead to or play a role in 125,000 deaths annually in the U.S. The PMI guide requirement would apply to human drugs and biologics and not to veterinary drugs, and would consist of a single page with information such as common side effects, directions for use, and warnings and contraindications.

This information would be provided to the patient with the prescription when issued in an outpatient setting. The proposal defines outpatient setting as including sites of care where the patient may take the prescription home and in non-inpatient settings where a healthcare provider administers the product to the patient.

The manufacturer would be required to make the PMI available to the FDA to release in a repository managed by the agency. FDA commissioner Robert Califf said in the May 30 FDA statement that this patient information guide would replace two other types of written information that are both required by and must be approved by the agency. Califf said these guides would help reduce the instances of accidental misinterpretations of the prescription.

The FDA currently requires medication guides only for prescription drug products that the agency believes may pose a serious public health concern in the context of misuse or abuse. However, the PMI draft rule would expand the scope of products that are covered under these patient information requirements. Manufacturers of generic drugs would be required to develop a PMI that for the most part would duplicate the PMI for the reference drug. The FDA said in the preamble that the PMI requirement, if adopted, would be subject to a five-year implementation schedule.