Drugs

Comments on Increasing Access to Non-Prescription Drugs

David McFarland

— 1 min read
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In response to an FDA request for comments on increasing access to non-prescription drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends the agency’s commitment to expanding the appropriate availability of non-prescription drugs. “While PhRMA is aligned with the goal of increasing access to non-prescription drugs,” the comment letter says, “Rx-to-OTC (over-the-counter) switch decisions must remain rooted in scientific analysis of safety and efficacy and must be made in line with FDA’s charge to protect public health. PhRMA believes that the core principle that pricing considerations may not factor into FDA regulatory decision-making must be respected.”

The trade association says that FDA should:

  • work with sponsors to determine whether a drug can be switched from prescription to non-prescription status;
  • preserve incentives to switch products; and
  • utilize tools provided through the ACNU (additional condition for non-prescription use) final rule to facilitate the availability of OTC products.

The Consumer Healthcare Products Association's response makes these points:

  • OTC is the default marketing status for human drugs based on the Durham-Humphrey Amendment of 1951;
  • prioritized list of disease/treatment considerations for OTC switches; and
  • innovation to support evaluation of OTC drug development programs.

The Yale Collaboration for Regulatory Rigor, Integrity, and Transparency organizes its comments in these categories:

  • consumer product identification and selection;
  • innovative approaches to expanding non-prescription access;
  • affordability and coverage in non-prescription access;
  • evidence supporting prescription to non-prescription switches; and
  • artificial intelligence technologies.

Finally, the American Pharmacists Association proposes a roadmap to ensure the ACNU framework successfully increases patient access while balancing safety concerns. It says FDA should take these three action steps to facilitate the movement of more pharmaceuticals from prescription to OTC with ACNU:

  • clarify clear pathways for Rx to OTC switch with ACNU;
  • work with the Centers for Medicare and Medicaid Services to require Part D plan sponsors, state Medicaid agencies, Medicare Advantage plans, and others to cover any additional requirements and additions to pharmacists’ workflow and establish mechanisms to reimburse patients for products purchased outside pharmacies under a technology-enabled self-evaluation pathway; and
  • work with the Office of the National Coordinator for Health Information Technology to call on HHS to leverage its influence on electronic health record systems to facilitate full integration of pharmacies and pharmacists wherever they exist in the healthcare system to ensure read/write access to the patient healthcare record.

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