The FDA chief on OTC drugs

Nelson Vergel · 2026-02-18T16:53:21-0600

Hopefully, this will apply to ED drugs

MAKARY OFFERS EXPANSIVE THEORY FOR WHICH DRUGS SHOULD BE OTC: AgencyIQ has previously written aboutwhat we believe is a massive and underreported shift at the FDA related to the process of switching prescription medications to over the counter. And as of this week, FDA Commissioner Makary continues to indicate that our prediction is correct, telling CNBC in an interview posted Feb. 18 that he hopes to roll out changes related to nonprescription drugs in 2026. “In my opinion, everything should be over the counter – not requiring a prescription – unless it’s unsafe, unless you need laboratory tests to monitor how it’s being received by your body, or if it could be used for some nefarious purpose or it’s addictive,” he said. “If it doesn’t meet those criteria, why shouldn’t a drug be over the counter?” Makary indicated that the FDA plans to act through “the proper regulatory processes with rulemaking,” including by changing the agency’s monographs. The CNBC interview follows other comments by Makary indicating a coming “mass transition” of prescription drugs to OTC. The FDA has recently updated internal procedures regarding nonprescription switching and solicited feedback from industry, which appear in preparation of future policy action. Speaking to CNBC, Makary suggested that vaginal estrogen and nausea medications might make good candidates for switching to OTC.

Nelson Vergel · 2026-02-18T16:54:11-0600

Thread 'Study of avanafil for OTC use in ED progresses'

Jan 26, 2024

Study of avanafil for OTC use in erectile dysfunction progresses

Overall, more than 78% of consumers were able to appropriately self-select to use avanafil using the drug facts label (DFL) and the assistive app, compared with 56% of consumers using the DFL alone.

www.urologytimes.com

The initial cohort of the phase 2 equivalent self-selection study (SSS) for over-the-counter (OTC) use of the oral phosphodiesterase 5 inhibitor avanafil (Stendra) for erectile dysfunction has successfully completed, according to a news release from Petros Pharmaceuticals, the developer of the treatment.1

An SSS is conducted to support the approval of non-prescription drugs. The study is designed to ensure that consumers can appropriately select to use a certain...