Proposed FDA Regulation Would Provide Much-Needed Updates to Consumer Medication Information


If finalized, the regulation would potentially reduce prescription nonadherence and accidental misuse.

If finalized, the FDA’s proposed Prescription Medication Information (PMI) regulation would revamp existing consumer medication information and potentially reduce prescription nonadherence and accidental misuse in the United States. The proposed rule would require the FDA to approve prescription medication information for all prescriptions dispensed or administered in outpatient settings and blood transfusion clinics with few exceptions.1

Accidental prescription misuse and nonadherence is considered a factor in 25% of hospitalizations, half of treatment failures, and approximately 100,000 deaths annually.1,2

Although complicated and multi-factorial in nature, studies have demonstrated the benefits of effective written communication in reducing nonadherence. Unfortunately, studies also suggest that common sources of consumer prescription information, in most cases developed independent of FDA input, are often too long, too technical, or flawed in other important ways.3

Female pharmacist handing prescription bag to a patient | Image credit: Rene La/ -

Female pharmacist handing prescription bag to a patient | Image credit: Rene La/ -

The proposed regulation’s aim is to improve consistency of the content and focus consumer attention on the 4 areas most important to understand: drug name, important safety information, common side effects, and directions for use. This would be achieved through agency consultation and with a revised 1-page format design to improve readability, clarity, and impact of the information provided. Importantly, the proposed format also meets consumer preference and acceptance criteria.3 Hence, the regulation should help improve prescription nonadherence and accidental misuse and provide several other benefits.

Improved prescription information could help consumers make better health care decisions and result in cost savings. The FDA estimates that PMI could provide a 10-year annualized savings benefit in the range of $120 million to $4.3 billion.4 These savings are achieved by reducing unnecessary hospitalizations and related health care costs. According to other FDA estimates, the 10-year annualized cost to industry to comply with the proposed PMI regulation is somewhere between $12 million and $40 million, a fraction of the proposed annualized cost savings benefit.4 From a United States health care perspective, initiatives that could simultaneously improve patient safety and achieve significant savings benefits are too important to not implement.

Another benefit of PMI regulation is that it could be implemented over a 5-year period without causing costly delays in the drug approval process. The proposed PMI guide would be incorporated into new drug and biologic license applications and reviewed by the FDA under existing timelines.4 Drugs and biologics that are already licensed would be required to comply with PMI regulations over time through a similar submission and review cycle.4 That means that the goals of PMI regulation—reduced nonadherence and accidental prescription misuse—could be achieved without slowing the pace of industry innovation.

As beneficial as PMI regulation could be overall, there are at least 3 areas where input from pharmacists could help strengthen it. First, the FDA should look into the costs and benefits of a requirement for PMI translations to be cleared by the FDA. Currently, the PMI proposal does not require FDA review of translations and instead only requires English versions to be distributed with translated versions. This may not fully tackle nonadherence problems caused by low health care literacy due to poor English literacy. If the economic cost savings case can be made for FDA-cleared translations for Spanish or other languages, the FDA should amend the proposal accordingly. Not to do so would defeat the regulation’s purpose and potentially miss an opportunity to reduce health care spending.

Second, the FDA should require digital PMIs as the default format, with paper printouts to be provided upon request only. The current proposal calls for a single page paper document to be printed each time a prescription is dispensed or administered in outpatient settings. An electronic format would of course conserve natural resources, reduce greenhouse gas emissions, and save money in printing costs. Digital PMIs are also better because they can be stored and accessed on mobile phones and other devices for future reference. Furthermore, not all outpatient blood transfusion clinics, which are covered in the PMI regulation, have the equipment and staff to provide paper printouts to consumers. Thus, electronic formats are a better option to pursue.

Third, to avoid confusion, the FDA should issue clear guidance to consumers on whether the new PMI guides supersede other types and formats of consumer medication information (CMI) that are not FDA cleared. Medication leaflets currently distributed by most pharmacies are a prime example. As noted earlier, studies have highlighted readability and consistency issues with CMI in the past. Therefore, the FDA should carefully explain to consumers why and how PMI is better and work toward eliminating unregulated consumer medication leaflets altogether if necessary.

Notwithstanding these 3 suggestions for improvement, the proposed PMI could help enhance patient safety and improve inefficiencies in health care spending. The scale and scope of the prescription nonadherence and accidental misuse problem facing the US warrants FDA intervention.

Furthermore, the PMI regulation focuses on the right areas to provide consumers with FDA-cleared information which clearly predefines and explains the most important things for a consumer to understand about their medication. Therefore, pharmacists should provide comments on the pending rule to ensure the final regulation can effectively reduce the risk of accidental prescription misuse and nonadherence in the United States.


1. Lam, W.Y. and P. Fresco, “Medication Adherence Measures: An Overview,” BioMed Research International, pp. 217047, 2015, doi:10.1155/2015/217047.

2. Kim, J., K. Combs, J. Downs, et al., “Medication Adherence: The Elephant in the Room,” U.S. Pharmacist, Vol. 43, Issue 1, pp. 30–34, 2018 (available at:,chronic%20medications%20is%20around%2050%25 ), accessed June 21, 2023.

3. Svarstad, B.L., J.K. Mount, and E.R. Tabak, “Expert and Consumer Evaluation of Patient Medication Leaflets Provided in U.S. Pharmacies,” Journal of the American Pharmacists Association, Vol. 45, Issue 4, pp. 443–451, 2005.

4. Medication Guides: Patient Medication Information Docket FDA-2019-N-5959-0001 accessed June 21,2023

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