FDA Mandated to Streamline Prescription-to-OTC Drug Switch Process Under New Congressional Legislation
核心洞察
Congressional legislation signed in November 2025 requires FDA to issue guidance by May 2027 to improve the clarity and predictability of prescription-to-OTC drug switch applications.
The new law establishes formal meeting pathways for companies to align with FDA on data requirements and study designs needed to support drug switches from prescription to over-the-counter status.
Pharmaceutical companies including Kenvue (搜索), Perrigo, and Opella are urging FDA to reduce regulatory complexity, citing the current switch process as rigorous as a new drug application with lengthy back-and-forth discussions.
The U.S. Food and Drug Administration faces new Congressional mandates to streamline the complex process of switching prescription drugs to over-the-counter status, as lawmakers and industry stakeholders push for greater medication accessibility and reduced healthcare costs.
The Congressional stopgap spending bill signed into law on November 12, 2025, includes provisions requiring FDA to issue guidance within 18 months to "increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs," particularly for prescription drugs with well-established safety profiles. The legislation, part of the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II), represents the most significant regulatory framework change for OTC switches in decades.
New Regulatory Framework Establishes Clear Pathways
The new law defines three types of prescription-to-OTC switches: full switches where nonprescription drugs are approved under the same conditions as prescription versions, full switches with additional conditions for nonprescription use (ACNU), and partial switches where drugs remain prescription-only under certain conditions while becoming available OTC for others.
Companies planning to submit New Drug Applications for Rx-to-OTC switches may now request formal meetings with FDA to develop application plans addressing "the potential risks to public health of such switch and the evidence necessary to support such application, including the design of any necessary studies, and the format and content of the planned application."
FDA Commissioner Marty Makary has made expanding OTC access a priority, posting on social media that the US "need[s] more drugs to be 'over-the-counter'" and stating that "FDA will be cutting red tape to deliver more safe and affordable OTC drugs!" The agency has authorized "substantial hiring" for nonprescription drug efforts to fill current vacancies and expand this initiative, according to FDA spokesperson Emily Hilliard.
Industry Calls for Regulatory Reform
Major pharmaceutical companies are supporting the initiative while requesting significant process improvements. Kenvue (搜索), manufacturer of Benadryl and Zyrtec, told the agency that the current process can result in programs getting mired in "very lengthy back and forth successive discussions" related to labeling formatting and language, adding years to programs. The company criticized FDA's "overly paternalistic approach" and recommended more pragmatic responses to submitted studies.
Perrigo noted that switches "often fail" during the regulatory process due to FDA concerns about patient behavior, suggesting that data from labeling comprehension studies should be accepted as sufficient evidence to demonstrate safe consumer self-selection and use.
"It is as rigorous as a regular new drug application," said Rachel Turow, a former FDA regulatory counsel now at Skadden Arps Slate Meagher & Flom LLP. "FDA is going to have to be flexible if they want to aggressively switch things to OTC."
The current process requires drugmakers to conduct and submit studies related to label comprehension, self-selection, and actual-use of drugs to demonstrate that consumers can use them without healthcare provider supervision. Over 100 ingredients, indications, or dosage strengths have been approved through the agency's switch process since the first authorized swap requiring a new application over 30 years ago, with the latest being Harm Reduction Therapeutics (搜索)'s opioid treatment RiVive (搜索) in 2023.
Congressional Oversight and Future Requirements
The legislation mandates additional accountability measures, requiring the General Accountability Office to provide a report by October 2027 assessing FDA's engagement with the public on OTC switches, the number of approved switch applications, average approval times, and barriers to timely review processes.
By November 2026, FDA must develop a plan "to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates" for OTC switches.
The agency has also issued a Request for Information on "how to increase access to nonprescription drugs," with comments accepted through January 31, 2026, and a public meeting planned for next year.
Potential Switch Candidates Under Discussion
Stakeholders have suggested various drug categories for potential switches, including treatments for anaphylaxis (搜索), erectile dysfunction (搜索), nausea (搜索), and menstrual pain. Commissioner Makary has specifically mentioned that naloxone, used to treat opioid overdose (搜索), shouldn't require a prescription, though higher doses and injectables currently still require physician oversight despite nasal spray versions being available over-the-counter.
"Drug sponsors need clearer expectations from the FDA," said David Spangler, senior vice president of legal, government affairs and policy for the Consumer Healthcare Products Association. "There's definitely some friction as sponsors and FDA talk about what you absolutely need to have to show people can use it safely and appropriately."
The new requirements come seven months after an Executive Order on "Lowering Drug Prices Once Again by Putting Americans First," which required FDA to provide recommendations to improve the prescription-to-OTC reclassification process by October 2025.