In an interview from February 2026, commissioner of the US Food and Drug Administration (FDA), Marty Makary, said that “everything should be over the counter (OTC)” except drugs deemed unsafe or addictive.
According to the FDA chief, making the switch to OTC could enhance patient autonomy, improve accessibility and reduce drug prices for patients.
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Prior to Makary’s debut as commissioner, the FDA made several moves to increase the proportion of drugs deemed OTC. One of these was the introduction of the Additional Condition for Non-Prescription Use (ACNU) framework, which allows medicines to be characterised as OTC as long as an extra control measure is used to enhance their safety in this setting. These conditions could be anything from a nurse consultation to a kiosk in a pharmacy.
Currently, the FDA holds the legal right to switch prescription medications to OTC, provided the decision goes through rulemaking. However, Heidi Gertner, ex-FDA senior counsel for drugs and partner at law firm Hogan Lovells, believes the wider shift to making more drugs OTC depends on engagement from the pharmaceutical industry.
This interview has been edited for length and clarity.
Annabel Kartal-Allen (AKA): Do you think that switching a notable proportion of prescription drugs to OTC will improve accessibility and healthcare costs for patients?
Heidi Gertner (HG): Accessibility would certainly improve, as you can just walk to the store and pick up a medication. Affordability is a bit harder to gauge, as a lot of US patients go through insurance. This means they have access to prescribed generic medicines, which may be cheaper all-in than buying an alternative OTC product off the shelf.
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By GlobalDataPharma companies are also going to have to recoup the money spent on validation studies they conducted to switch, as well as the associated application fees, which could drive up the cost of medicines making the prescription-to-OTC switch. The more the treatment costs, the less likely it is that patients will buy these drugs and remain compliant with the treatment protocol like the government’s hoping for.
AKA: What are the safety risks that the FDA must consider when switching drugs to OTC?
HG: A lot of people think it’s important to have a physician managing their healthcare across the board, as they can identify if a patient is at risk of adverse reactions associated with drug interactions. I think, especially for elderly patients with comorbidities who take a lot of medications, there could be negative effects of taking these drugs without a doctor managing you, keeping tabs on what you’re ingesting and advising you on what could be problematic to add on and continue taking.
It’s true that all drugs have associated risks, and the agency must keep this in mind when considering if a medicine is safe in the OTC setting, under conditions of widespread availability where anybody could access it. The agency will have to consider how the drug might interact with other medications, as well as the risk a patient may be exposed to if they take the drug incorrectly.
AKA: How likely is it that the FDA will make all drugs that aren’t deemed unsafe or addictive OTC in the near-term?
HG: Within five years or so, we will probably see some more prescription-to-OTC switches. Things are definitely moving in the direction that Makary suggested, but the change isn’t going to be some quick overnight thing. The OTC switch will likely occur on a drug-by-drug or category of drug basis, and it’s going to take data, review by the agency and submission of applications by pharma – which will all take time.
There’s a provision in the statute that’s been there for years that allows the FDA to independently decide if a drug no longer requires a prescription, providing the decision goes through rulemaking – though the agency has not yet switched a medication to OTC on its own. It would be hard for the FDA to order a drugmaker to switch their product in this way, as the company would be responsible for submitting the labelling and marketing the product. All the switches we’ve seen thus far have been industry-initiated.
AKA: Do you think the pharma industry will be motivated to switch drugs to the OTC setting?
HG: Pharma companies first need to decide if taking their prescription drugs to the OTC setting is something they’re interested in.
Though a company might see wider availability and use of its drug when switching to an OTC model, there are several business considerations – including the probability of switch success, the financial and time-based costs of developing an application and collating data to support a switch versus return, as well as the need to adapt a drug’s distribution model to suit the OTC setting. If a company is commercialising an OTC product with an ACNU, they will also have to financially support and maintain the functioning of the additional condition, whether that be a mobile app or a kiosk in a pharmacy.
AKA: Do you think that the ACNU framework could provide an effective approach for the FDA to more widely switch prescription drugs to OTC?
HG: I think it’s a pathway that both the FDA and consumers could get behind, as the rule enforces extra precautions that could help keep a drug safe in the OTC setting. This could be more palatable to regulators and allow pharma companies to get creative in how they put precautions in place. There are some really interesting technologies that could be implemented to help patients safely use a drug in the OTC setting, which could be used to gauge a patient’s eligibility for a medicine or determine the right dosage for their needs.
Not everyone will know how to properly use a drug based on the label alone, or some may have challenges reading the labelling based on their condition, so this additional element of regulation could make up for these gaps.
AKA: Have you noticed any wider changes in the FDA’s regulatory stance in recent times?
HG: The FDA accepting real-world data to establish a drug’s safety is a big one, as well as the plausible mechanism pathway and allowing sponsors to file for a drug’s approval based on one pivotal trial to support safe use instead of two. These are big initiatives that may not necessarily relax data standards, but they will allow for the use of data from different sources. The agency is also looking to phase out animal testing, so there’s been a lot of interesting changes.
The FDA has traditionally been much more conservative in its thinking and more paternalistic in protecting public health. Now, it feels like we’re embracing different, less rigorous scientific standards to help establish safety and efficacy. The gold standard was always animal testing and two adequate and well controlled studies, and now we’re moving away from both those things; it’s a different way of thinking.
While the standards themselves in the statute haven’t changed for the approval of a drug product, the way to get there seems to be shifting in terms of the types and quantum of data needed. It could be considered a slight relaxation of standards, or it could also just be a different pathway to get there. However, I do think that all of these points signal that the FDA is being less traditional. The agency is also keen to use technology to advance drug development and availability, which could prove beneficial.
