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FDA’s proposed rule would facilitate prescription-to-OTC switches



After a decade-long wait, the Food and Drug Administration finally issued a proposed rule in late June that would make it easier for pharmaceutical companies to switch products from prescription-only to over-the-counter status while still retaining a prescription version.

Under the rule, patients would enjoy access to medications that previously required an office visit and a prescription, while payers would reap the financial benefits of fewer medical and prescription claims. Whether the change would be a challenge or an opportunity for pharmacies depends entirely on how the rule is implemented.

Under the proposed rule, an OTC drug could have the same active ingredient, dosage form, strength, route of administration, and indication as its prescription-only counterpart.

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What the rule does not do is create a third class of drugs that would not require a prescription yet, instead of being available over the counter, would be “behind-the-counter” and could be purchased only after consulting with a pharmacist. The possibility of this third class has been in play since 2012.

The proposed rule would establish an Additional Condition for Nonprescription Use category for prescription products the FDA says consumers currently can’t appropriately self-select and use without a prescription. This is somewhat analogous to the Risk Evaluation and Mitigation Strategies, which allow certain prescription drugs with potential safety issues to be approved for patients with additional requirements for use, such as verifying a negative pregnancy test for a drug that can cause birth defects or requiring a monthly lab test before the drug can be dispensed.

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With an ACNU, a drug company must meet several FDA-approved conditions to ensure that consumers appropriately self-select a medication, appropriately use it, or both without the supervision of a health care practitioner. The FDA has kept the definition broad of what fulfilling an ACNU may entail, but patient education is certainly key. Two specific examples the FDA has suggested are requiring patients to complete a questionnaire or view a video, both with assessments to confirm their understanding of the medication.

In addition to broadly defining an ACNU, the FDA appears to be offering manufacturers significant flexibility in determining how to operationalize or implement it. Examples provided in the proposed rule include providing information via in-pharmacy kiosks, apps, and online.

A company seeking to add over-the-counter status to a drug may submit a New Drug Application or an Abbreviated New Drug Application that references the drug’s original application. In the new application, the company must provide key elements of the ACNU and how it will be operationalized or administered. The FDA will require data from robust self-selection and label comprehension studies to demonstrate that labeling alone is not sufficient for people to self-select the medication, such as difficulty calculating the risk of a side effect. The application must also specify exactly how the ACNU will result in consumers being able to self-select the product.

An applicant could propose in an application, for example, that a consumer would need to respond with specific answers to a set of questions on an app or via an automated telephone response system in order to purchase a non-prescription version of the drug.

The proposed rule would establish additional labeling and post-marketing reporting requirements for non-prescription products with an Additional Condition for Nonprescription Use. Failures or deviations from the ACNU, such as a consumer gaining access to the medication without completing the requirements, or any event which actually causes or could potentially lead to inappropriate patient use or patient harm, would be reportable to FDA.

Over-the-counter products have traditionally been for acute, self-limiting conditions. With this proposed rule, however, the FDA has indicated flexibility in allowing for OTC use of certain prescription medications for chronic diseases or conditions, such as high cholesterol, diabetes, and high blood pressure.

The proposed rule would clearly expand consumer access to a wider range of non-prescription drugs, increasing patient autonomy and possibly improving public health. It would also have enormous potential for the pharmaceutical industry to expand use of what are currently prescription-only drugs.

While the FDA anticipates cost savings to patients who switch from prescription to OTC drugs, this is not certain, as payers have traditionally excluded over-the-counter products from insurance coverage; patients pay for them out of pocket. It isn’t yet clear if payers will reimburse patients for the out-of-pocket expenses for these new OTC drugs, or if they will shift the cost to patients.

To be sure, fewer medical visits to get prescriptions and requests for prescription medications will mean fewer medical claims for payers.

What impact would the proposed rule have for community pharmacies? There has been considerable debate over the last few decades about creating a third class of behind-the-counter drugs that can be bought only after consulting with a pharmacist.

The FDA held a hearing in 2012 about this class of drugs, which would have been positioned as an expanded non-prescription drug class under the FDA’s Nonprescription Safe-Use Regulatory Expansion Initiative. The rule the FDA proposed in June refers to the 2012 hearing, but does not mention NSURE, nor does it mention pharmacist oversight or any counseling requirements. In fact, the proposed rule barely mentions pharmacy at all.

The impact for community pharmacies that sell these new over-the-counter drugs with Additional Condition for Nonprescription Use will be great, depending on the product. Consumer demand for statins for high cholesterol, for example, may be massive.

Pharmacies may need to install kiosks for consumers to complete questionnaires, view videos, take assessment quizzes, and the like if new OTC drugs come with requirements ensuring appropriate self-selection and use. However, the rule refers to retail stores and not pharmacies, per se. Additionally, the ACNU may be operationalized via other platforms such as mobile apps or online.

How over-the-counter drugs approved under an Additional Condition for Nonprescription Use will be dispensed must be addressed, especially since over-the-counter drugs are sold in a variety of venues, ranging from pharmacies to dollar stores and gas stations. Many questions must be answered: Should these drugs be sold in any location, or should they be limited to sale in pharmacies where a pharmacist is present? Should they be over-the-counter or behind-the-counter? Can pharmacies secure a third class of drugs based on the FDA’s proposed rule?

The FDA’s proposed rule has important ramifications as it will decrease the number of prescriptions written and dispensed. The public comment period on the proposed rule is set to expire on October 26, 2022. Given the many questions the rule raises and the need for further details, especially with regard to the potential impact to the pharmaceutical industry and pharmacy profession, I encourage stakeholders to make their voices heard.

Martha M. Rumore is senior counsel at Frier Levitt LLC in New York, whose practice focuses on food, drug, and cosmetic law and intellectual property. She is also an adjunct professor of law at the Maurice A. Deane School of Law at Hofstra University in New York.





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