By: Amanda Kastel, PharmD Candidate c\/o 2027<\/p>\n\n\n\n
In February 2026, FDA Commissioner Marty Makary stated in a press conference that: \u201cEverything should be over the counter, unless a drug is unsafe, addictive, or requires monitoring.\u201d1<\/sup> He argued that this approach could reduce medication costs for consumers by bypassing pharmacy benefit managers (PBMs). Additionally, he stated that expanding over-the-counter access would improve accessibility and reduce unnecessary barriers to treatment. While improving access to medication may seem positive, there are many concerns regarding cost, safety, and the ability of patients to self-treat safely without the guidance of a healthcare professional.<\/p>\n\n\n\n Makary noted that the FDA is exploring regulatory changes this year that would allow more companies to offer their prescription medications over the counter. The FDA is actively updating OTC monographs to allow this to become a reality. While Makary did not provide a comprehensive list of all the medications that he believes should be OTC, he specifically referenced vaginal estrogen and anti-emetic medications as potential candidates for reclassification.1<\/sup><\/p>\n\n\n\n Vaginal estrogen is indicated for postmenopausal women to treat genitourinary symptoms of menopause including vaginal dryness, irritation, and dyspareunia. While making this medication more accessible to women may seem beneficial, there are potential concerns if it does become OTC. For example, though vaginal estrogen is minimally absorbed into the bloodstream, there are some concerns of an antagonistic effect with aromatase inhibitors such as anastrozole, potentially increasing the risk for cancer recurrence. Although the evidence regarding this risk is limited and largely observational, the mechanism is biologically plausible, and, at the very least, patients should be counseled on the potential risk \u2013 which would likely not happen if the drug moved to OTC.<\/p>\n\n\n\n Though Makary did not specify a particular anti-emetic, commonly used prescription antiemetics such as ondansetron are often discussed in this context. For example, Dr. Marlena Fejzo, a well-known researcher in hyperemesis gravidarum, has publicly argued that restrictions on ondansetron are harmful to patients.2<\/sup> Though Zofran (ondansetron) may seem to be a relatively safe medication, there are some concerns regarding QT prolongation and the potential for ventricular arrhythmias, particularly in patients taking concomitant QT-prolonging agents.<\/p>\n\n\n\n A 2023 systematic review\u00b3 evaluating oral and intravenous ondansetron reported a dose-dependent increase in QT interval, with greater risk observed in older adults, patients with electrolyte abnormalities, and those concomitantly taking other QT-prolonging agents. However, this study did not separate results for intravenous and oral ondansetron and instead pooled them together. The evidence for exclusively oral ondansetron demonstrating statistically significant increases in QT prolongation and fatal arrhythmias remains limited. Despite this, broader availability could increase the likelihood of unintentional polypharmacy with other QT-prolonging agents, thereby increasing risk in susceptible individuals.<\/p>\n\n\n\n In addition to safety concerns, the economic impact of prescription drugs switching to OTC status should not be overlooked. When medications transition to OTC status, they are removed from many insurance formularies, and the economic burden is placed directly on the consumer. This exact pattern was seen when Voltaren (Diclofenac) 1% Gel moved to OTC in 2020, causing many payers to discontinue coverage.4<\/sup><\/p>\n\n\n\n Without appropriate safeguards, broad expansion of OTC availability may introduce both clinical and financial consequences. A more balanced approach could involve \u201cbehind the counter\u201d classification for select medications, similar to pseudoephedrine. Under this model, pharmacist involvement would help to ensure that patients are appropriately assessed for risk factors or contraindications before unknowingly selecting treatment that may increase their risk for serious harm.<\/p>\n\n\n\n References:<\/p>\n\n\n\n By: Amanda Kastel, PharmD Candidate c\/o 2027 In February 2026, FDA Commissioner Marty Makary stated in a press conference that: \u201cEverything should be over the counter, unless a drug is unsafe, addictive, or requires monitoring.\u201d1 He argued that this approach could reduce medication costs for consumers by bypassing pharmacy benefit managers (PBMs). Additionally, he stated…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-4216","post","type-post","status-publish","format-standard","hentry","category-news-politics"],"views":10,"_links":{"self":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4216","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/comments?post=4216"}],"version-history":[{"count":1,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4216\/revisions"}],"predecessor-version":[{"id":4217,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4216\/revisions\/4217"}],"wp:attachment":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/media?parent=4216"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/categories?post=4216"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/tags?post=4216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
\u00a0Accessed April 14, 2026.<\/li>\n\n\n\n