FDA Regulation of Nonprescription Drugs in Spotlight

FDA has been struggling for more than 10 years to devise policies and operations to facilitate the approval and marketing of over-the-counter (OTC) medications. In a major step forward, two years ago Congress authorized a new approval process for converting drugs from Rx to nonprescription status, along with new user fees to support a more efficient FDA regulatory program for these medicines. Most recently, FDA has proposed a new process to facilitate approval of an additional category of nonprescription medicines that carry certain limitations on use, but don’t require prescriptions from a doctor.

The initiative for modernizing FDA’s oversight of nonprescription drugs has also encouraged pharma companies to seek approval of OTC contraceptives. Perrigo’s HRA Pharma announced on July 12, 2022 that it has filed an application to market its birth control pill Opill on a nonprescription basis. The move involves an Rx-to-OTC switch for this progestin-only daily “mini” pill, which was approved by FDA in 1973, although is no longer widely used in the United States. The application was submitted by Paris-based HRA Pharma, which was recently acquired by Perrigo, a leading global OTC pharmaceutical manufacturer based in Dublin. HRA markets Opill in Britain and Europe and expects FDA’s 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 FDA for several years on switching its Zena combination estrogen-progestin prescription birth control pill to nonprescription status. A main hurdle has been FDA’s usual request for data from an “actual use” clinical trial, a requirement that Cadence may seek to address through a technological educational interface for patients.

Speeding OTC access

These moves to enhance patient access to OTC contraceptives is occurring at a time of much change in FDA nonprescription drug regulation. After years of underfunding the agency’s program for overseeing OTC drug development and approval, Congress enacted major reforms for the program as part of the Coronavirus Aid, Relief and Economic Security Act (CARES), passed in March 2020 to address the pandemic. The legislation authorized FDA to collect user fees from manufacturers of $110 million over five years to help expand the Office of Nonprescription Drugs in the Center for Drug Evaluation and Research (CDER). The aim was to overhaul its stagnant OTC monograph system, which utilized FDA’s rulemaking process to carry out Rx-to-OTC switches, a process that often took years.

Under the new program, FDA has rolled a series of final administrative orders for issuing and revising OTC monographs under this more expeditious process, including a high-profile monograph for sunscreens. CDER also has published guidance documents for implementing the program and has several more on its agenda, including those on dispute resolution procedures, various meeting types, and e-data submission procedures.

Most recently, FDA published a new proposed rule to facilitate the development of a new class of medicines that carry an Additional Condition for Nonprescription Use (ACNU). The aim is to enhance access to certain Rx medicines that are found to need additional instructions and safeguards to ensure correct selection and safe patient use, but still warrant easier access than for prescription medicines. The proposal spells out how manufacturers may submit an application proposing a drug with an ACNU that can be implemented to ensure appropriate consumer self-selection and product use, possibly through answering certain questions at a pharmacy kiosk or on a mobile app or automated telephone response system. FDA seeks comments on the potential benefits and potential pitfalls of the proposed system.

A main issue for all OTC products is cost and coverage. While nonprescription drugs often are less expensive than Rx therapies, consumers usually pay for OTC products out of pocket, while health insurance plans cover much of the cost of prescriptions. There is some pressure for payers to pick up more of the tab for certain OTCs, such as contraceptives, as they would save money from fewer doctor office visits and generally lower product prices. Additionally, payment status is murky for “behind-the counter” medicines, an area that may expand noticeably under a recently proposed new rule. The coverage issue will be spotlighted for OTC contraceptives, as the Affordable Care Act requires health insurers to provide coverage for prescription birth control pills but would not necessarily apply to nonprescription products.

About the author

Jill Wechsler is Washington editor for BioPharm International.