FDA regulations on over-the-counter drugs in the spotlight

The demand for over-the-counter contraceptives highlights efforts to expand access to drugs.

The FDA has struggled for more than 10 years to design policies and operations to facilitate the approval and marketing of over-the-counter (OTC) drugs. In a major breakthrough, two years ago Congress authorized a new approval process to convert Rx drugs to nonprescription drugs, along with new user fees to support a stronger FDA regulatory agenda. effective for these drugs. More recently, the FDA proposed a new process to facilitate the approval of an additional class of over-the-counter drugs that have certain usage limitations but do not require a doctor’s prescription.

The FDA’s OTC Drug Oversight Modernization Initiative has also encouraged pharmaceutical companies to seek approval for over-the-counter contraceptives. Perrigo’s HRA Pharma announced on Tuesday that it has filed an application to market its contraceptive pill Opill without a prescription.1 The move involves a switch from Rx to OTC for this daily progestin-only “mini” pill, which was approved by the FDA in 1973, although it is no longer widely used in the United States. The application was submitted by Paris-based HRA Pharma, which was recently acquired by Perrigo, one of the world’s leading manufacturers of over-the-counter pharmaceuticals based in Dublin. HRA markets Opill in Britain and Europe and expects its FDA review of its application to take 10 months, despite calls from Democratic leaders and health advocates to speed up the process.

Meanwhile, Cadence Health of Oakland, Calif., has been working with the FDA for several years to move its Zena prescription birth control pill that combines estrogen and progestins to non-prescription status.2 One of the main hurdles has been the FDA’s usual request for “real-use” clinical trial data, a requirement that Cadence may seek to address through a technological patient education interface.

OTC Access Acceleration

These moves to improve patient access to over-the-counter contraceptives come at a time when the FDA’s over-the-counter drug regulations are undergoing major changes. After years of underfunding the agency’s program to oversee the development and approval of over-the-counter drugs, Congress passed major reforms for the program under the CARES Act (Coronavirus Aid, Relief, and Economic Security Act), adopted in March 2020 to combat the pandemic. The legislation authorized the FDA to collect user fees from manufacturers of $110 million over five years to help expand the Center for Drug Evaluation and Research (CDER) Office of Over-the-Counter Drugs. The goal was to overhaul its stagnant OTC monograph system, which used the FDA’s rulemaking process to make changes from Rx to OTC, a process that often took years.

Under the new program, the FDA has launched a series of final administrative orders for the issuance and review of over-the-counter monographs under this faster process, including a high-profile monograph for sunscreens.3 CDER has also issued guidelines for program implementation and has several more on its agenda, including those on dispute resolution procedures, various types of meetings, and electronic data submission procedures.

More recently, the FDA issued a proposed new rule to facilitate the development of a new class of drugs that carry an additional condition for use without a prescription (ACNU).4 The aim is to improve access to certain Rx drugs which require additional instructions and safeguards to ensure correct selection and safe use by patients, but which still warrant easier access than for prescription drugs.5 The proposal clarifies how manufacturers can submit an application proposing a medicine with an UNAC that can be implemented to ensure appropriate self-selection and use of the product by the consumer, possibly by answering certain questions at a kiosk of pharmacy or on a mobile application or an automated telephone answering system. . The FDA invites comments on the potential benefits and potential pitfalls of the proposed system.

A major issue for all OTC products is cost and coverage. Although over-the-counter drugs are often less expensive than Rx therapies, consumers generally pay for over-the-counter products out of pocket, while health insurance plans cover much of the cost of prescriptions. There is some pressure on payers to take a larger share of the tab for certain OTCs, such as contraceptives, as they would save money through fewer doctor visits and lower prices of products generally lower. Additionally, payment status is murky for “behind the counter” drugs, an area that could expand significantly under a recently proposed new rule. The coverage issue will be highlighted for over-the-counter contraceptives, as the Affordable Care Act requires health insurers to provide coverage for prescription birth control pills, but would not necessarily apply to over-the-counter products. free.


  1. https://www.hra-pharma.com/articles/perrigos-hra-pharma-submits-application-to-fda-for-first-ever-otc-birth-control-pill-66
  2. https://www.cadenceotc.com/zena/
  3. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act
  4. https://www.govinfo.gov/content/pkg/FR-2022-06-28/pdf/2022-13309.pdf
  5. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/fda-announces-proposed-rule-nonprescription-drug-product-additional-condition-nonprescription-use

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