FDA proposes new ways for prescription drugs to become available over-the-counter

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a prescription, drugs that are currently available only by prescription.


The draft guidance would facilitate these prescription (Rx) to Over-The-Counter (OTC) switches by allowing certain new conditions to ensure safe use.  To qualify for sale without a prescription, a drug must not meet the standard for a prescription drug in the Federal Food, Drug, and Cosmetic Act, and consumers must be able to self-diagnose, self-select, and self-medicate.  Historically, FDA expected consumers to make their OTC drug choices based solely on the conditions outlined in the products’ drug facts label (DFL).  This guidance, however, offers two new approaches for potentially switching Rx drugs to OTC in situations where the DFL alone is insufficient to ensure safety and efficacy in a nonprescription setting:

  1. FDA states that it could approve additional labeling beyond the DFL to ensure safety and efficacy via leaflets or digital platforms such as mobile applications, or
  2. FDA could add conditions of use to ensure consumers appropriately self-select and use the product, such as requiring that consumers to answer a questionnaire or affirm that they understand how to appropriately take the medication by viewing text or video images on appropriate use.

In a statement announcing the guidance, FDA Commissioner Scott Gottlieb, M.D., said this new framework could help lower health care costs, but he stressed that FDA is “not proposing a change in the evidentiary standard needed for a product to be approved by the FDA as nonprescription.”  The guidance maintains the importance of drug companies submitting data to the FDA showing consumers are capable of accurately assessing their need for a medication and their ability to use it correctly, citing its April 2013 guidance on the issue.

The draft guidance states that the approach described in this initiative could lead to approval of a wider range of OTC drug products, including those intended to treat chronic conditions, or other conditions for which it is difficult to ensure safe and effective use based solely on the DFL.  Dr. Gottlieb’s statement specifically identifies cholesterol lowering drugs and naloxone as possible drug candidates that could benefit from this approach.

A “first step” toward expanding OTC drug availability

This guidance continues a decade-long trend of FDA movement toward OTC drug review process reform.  FDA had considered the legality of creating a “behind-the-counter” (BTC) nonprescription designation for chronic disease drugs in 2007, and a 2009 GAO report assessed the idea, concluding it could raise out-of-pocket costs for those drugs but that it could also increase the availability of those drugs.  Then, in 2012, FDA announced the Nonprescription Drug Safe Use Regulatory Expansion (NSURE) idea to consider ways to help drugs switch from prescription-only to OTC availability.  Most recently, in 2014, FDA took steps to review the regulatory framework for OTC drug review, as we discussed here.

Dr. Gottlieb called Tuesday’s draft guidance a “first step” toward expanding which drug products could be considered nonprescription drugs, and he said FDA is planning to issue a proposed rule “in the near future” clarifying the requirements for marketing nonprescription drugs.  The Administration’s Spring 2018 Unified Agenda reflects FDA’s intention to issue the proposed rule by February of 2019.

US House passes OTC monograph reform act

The draft guidance comes on the heels of the US House of Representatives’ Monday passage of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, which would streamline and modernize FDA’s OTC drug review process, with challenges and opportunities described in this White Paper.  Notably, the bill would grant 18 months of exclusivity to makers of innovative OTC drugs; a version of the bill pending in the US Senate would grant 24 months of exclusivity.


Authored by Heidi F. Gertner and David Horowitz

Heidi Gertner
Washington D.C.
David Horowitz
Washington, D.C.


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