The U.S. Food and Drug Administration (FDA) is currently considering a significant shift in how medications are made available to the public, exploring the possibility of expanding the range of prescription drugs that could be sold over the counter (OTC) without a prescription. This potential change, announced by FDA commissioner Martin Makary in a recent interview, suggests a future where “everything should be over the counter,” except for drugs that are unsafe, addictive, or require clinical monitoring. While this vision promises to increase drug accessibility, it has also sparked debate among pharmacy experts who caution about the complexities and safety risks involved.
At present, the FDA regulates which drugs require a prescription and which can be sold OTC based on rigorous scientific evaluation. OTC medications must adhere to FDA-approved monographs — standardized guidelines that apply to all manufacturers of a particular drug. These monographs ensure that the drugs are safe and effective for use without direct supervision from a healthcare provider. Some drugs, however, remain prescription-only due to the need for clinical oversight, risk of misuse, or potential side effects. For example, using certain OTC drugs at higher doses or for conditions not specified on the label still requires a prescription.
Pharmaceutical companies can request a formal “Rx-to-OTC switch,” a process through which prescription drugs undergo detailed FDA review to determine whether they can be safely sold without a prescription. This pathway has historically allowed some medications, such as certain birth control pills and nasal steroids for allergies, to transition to OTC status. These changes tend to make sense when the drugs involve localized treatment with minimal systemic absorption and low risk of serious side effects.
Makary’s recent comments highlight the FDA’s interest in revisiting the criteria for OTC eligibility, potentially broadening it to include drugs like vaginal estrogen and antinausea medications. However, experts like Gina Moore, a pharmacy law scholar at the University of Colorado Anschutz Medical Campus, express caution about the idea that “everything” should be OTC. She acknowledges that some drugs might reasonably become available without a prescription but warns that a wholesale shift without careful consideration could be problematic.
One of the primary concerns raised by experts centers on patient safety and the increased responsibility placed on individuals. Paul Beninger, a retired professor of public health and community medicine at Tufts University, points out the numerous nuances patients must understand when taking medications independently. These include the correct dosages, timing, potential drug interactions, and recognizing side effects. Without healthcare provider oversight, there is a risk that patients may misuse medications or fail to identify adverse reactions promptly.
An important safety consideration in evaluating drugs for OTC status is the concept of the “therapeutic window.” This term refers to the range between the minimum effective dose and the dose at which the drug becomes toxic. Drugs with narrow therapeutic windows, such as those used in heart or lung conditions, require precise dosing and regular monitoring to avoid harmful effects. These drugs, experts agree, are unlikely candidates for OTC status due to the risk of toxicity if misused.
Additionally, some medications carry a risk of addiction or misuse, including opioids and benzodiazepines. These controlled substances demand careful supervision and are generally unsuitable for OTC sale. Even seemingly benign drugs like aspirin and acetaminophen can be toxic if taken in excessive amounts, underscoring the importance of clear guidelines and patient education.
Experts also emphasize that drugs intended for occasional use, such as allergy or cold medications, are better suited for OTC availability than those prescribed for chronic conditions like hypertension or diabetes, which require ongoing monitoring and adjustment. Furthermore, medications that require complex administration methods, such as injections or intravenous infusions, inherently need medical supervision and are unlikely to be moved to OTC status.
Another layer of complexity involves drug interactions. Many medications can interact with other drugs or foods, altering their effectiveness or increasing toxicity. For example, some drugs may inhibit the metabolism of others, requiring dose adjustments or timed administration to avoid adverse effects. While such warnings can be included on drug labels, the information can quickly become complicated, posing challenges for patients managing multiple medications on their own.
Beyond safety, there are practical considerations related to cost and insurance coverage. Moore notes that many prescription drug plans do not cover OTC medications. If more drugs become OTC, patients might face higher out-of-pocket expenses, potentially limiting access for those who previously relied on insurance coverage for prescription versions. This shift could create financial barriers for some individuals, despite the increased availability of medications.
The FDA has not disclosed a specific list of drugs under consideration