Industry groups seek changes to nonprescription drug access proposal

Regulatory NewsRegulatory News | 29 November 2022 |  By 

Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requirements for nonprescription drug products with an additional condition for nonprescription use (ACNU), including how an ACNU is deemed necessary.
The proposed rule, which was issued in June 2022, outlined additional application, labeling and postmarketing reporting requirements for nonprescription drugs with an ACNU. FDA has said the proposal is aimed at improving access to nonprescription drug products in cases where labeling alone is not enough to ensure appropriate self-selection and use by consumers (RELATED: FDA proposes rule broadening nonprescription drug access for consumers, Regulatory Focus 28 June 2022).
Determining an ACNU
The Pharmaceutical Research and Manufacturers of America (PhRMA) requested that FDA shift the onus for showing that an ACNU is necessary from the applicant to the agency, similar to how the FDA determines whether a drug requires a Risk Evaluation and Mitigation Strategy (REMS). As currently written, the proposed rule requires new drug application (NDA) applicants for a nonprescription drug product with an ACNU to “prove a negative,” showing that labeling is “insufficient to manage the safe and effective selection and use of the product.” PhRMA called this requirement “unduly burdensome” for applicants.
The Consumer Healthcare Products Association (CHPA), which represents manufacturers and marketers of over-the-counter (OTC) medical products, wrote that sponsors should not have to “fail first,” showing data from a failed study that demonstrates that labeling alone is insufficient to support appropriate self-selection or use. Instead, CHPA commented that it wanted to see greater flexibility from FDA to allow sponsors to propose an ACNU as part of an original prescription-to-nonprescription switch application.
“An applicant could assess the need for an additional condition at any stage during the research and development (R&D) process and, as part of its development program, provide its rationale for proposing the additional condition to the Agency,” CHPA commented. “The rationale to support the use of the ACNU may include study data, publicly available information from prior FDA meetings, or other valid sources of information.”
Bayer Consumer Health, which supported the aims of the proposed rule, commented that sponsors should be able to propose use of an ACNU and to present alternative sources of information. Additionally, Bayer supported the removal of the “fail first” concept as a requirement in the final regulations.
“Throughout an Rx-to-OTC switch development program, it can become apparent for a variety of reasons, including difficult/failed pre-tests, that labeling alone is not adequate to achieve the desired self-selection or use outcomes,” Bayer commented. “Incorporating these recommendations have the potential to decrease the time and expense of a switch development plan, resulting in the potential for more timely consumer access to new OTC medicines.”
Simultaneous marketing
CHPA also objected to the provision in the proposed rule that allows for simultaneous marketing of prescription drug products and nonprescription drug products where the only difference is the ACNU. CHPA asserted that there is “insufficient legal basis” for concluding that the existence of an ACNU alone would create a “meaningful difference” between nonprescription and prescription drug products that otherwise have no differences in indication, strength, route of administration, dosage form, or patient population. Additionally, CHPA commented that simultaneous marketing could lead to inaccurate case reporting of adverse events between the nonprescription drug product with ACNU and the prescription drug product and could lead to consumer confusion about the two products.
The American Heart Association (AHA) commented that it supports the ability to simultaneously market nonprescription drug products with an ACNU and their comparable prescription drug products. However, the group asked FDA to consider how this move could impact prescription drug coverage by health insurers. “Effort should be made to mitigate unintended consequences, including the proliferation of cost and coverage barriers that may impede patient access to critical prescription drugs,” AHA wrote.
Access and safety
The AHA also raised concerns about how the proposed rule could impact equitable access to drug products and safety. For example, they commented that drug-drug interactions must be accounted for as part of the ACNU and that self-selection criteria should include questions about vitamins, complementary and alternative medicines, and other nonprescription medicines that could cause adverse reactions. Additionally, the AHA commented that as currently written the proposed rule may not ensure that an ACNU would be operationalized in a way that would allow drug access for patients with limited health and digital literacy.
Meanwhile, the National Alliance of State Pharmacy Associations (NASPA) raised legal and safety concerns about the implementation of ACNU. For example, some states prohibit the sale of drugs via kiosks, potentially putting the proposed rule at odds with state drug laws. NASPA also voiced concerns about potential legal liability for pharmacists and pharmacies if nonprescription drugs with an ACNU are sold in a pharmacy without a pharmacist’s oversight and assessment.
“The proposed rule does not make it clear that if the ACNU products are sold in a pharmacy via a kiosk, pharmacists may be held responsible for patient compliance with the regulations, creating an administrative burden and a legal liability,” NASPA wrote.
Public comments on proposed rule for nonprescription drugs with ACNU


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