October 1, 2023


Advocacy. Mediation. Success.

Opening Up the OTC Market

Cross-posted on Objective Intent

This week, FDA announced a new draft assistance “Innovative Methods for Nonprescription Drug Products” supposed to expand the assortment of medication accessible in excess of-the-counter (OTC). Precisely, the agency’s proposal signifies a willingness to make accessible OTC medication for sure traditionally prescription-only therapeutic categories—such as overdose reversal medication, like naloxone, or cholesterol-reducing medication. As I explained to a journalist yesterday, in general I see this as a favourable step—and just one that is regular with lengthy-standing desire in creating more medication accessible without the need of a take a look at to a medical professional, like desire at the state and local stage.

OTC medication frequently get to current market by means of just one of two routes—they are promoted (1) pursuant to an OTC monograph (a regulation that, in essence, sets out the situations that a company can adhere to to current market its drug without the need of getting FDA’s premarket acceptance) or (2) beneath an accepted new drug application.  The new draft assistance applies to all those medication that are (or would be) promoted beneath a new drug application.

Food and drug administration is not proposing to transform its common for approving purposes for OTC medication. A producer nonetheless have to display that its drug’s added benefits outweigh pitfalls in the OTC context, thinking about, for instance, regardless of whether consumers can self-diagnose their affliction, regardless of whether consumers can tell regardless of whether the drug is operating for them, regardless of whether consumers can fully grasp how to use the drug, and the severity of the pitfalls related with the drug.

In its place, Food and drug administration is suggesting that there could be modern ways—through supplemental labeling or “conditions for safe and sound and productive use”—to guarantee that a broader assortment of medication have added benefits that outweigh their pitfalls in the OTC context. For instance, probably a quiz on a cell app could help consumers recognize regardless of whether a certain drug is correct for them.  The hope is that creating more medication accessible OTC will improve affected person access—because OTC medication would be lower cost and there would be fewer logistical hurdles to having OTC medication (e.g., there is no need to have to routine and go to a doctor’s appointment for a prescription).

The new draft assistance is regular with lengthy-standing desire in expanding patients’ alternatives for accessing medication without the need of a take a look at to a medical professional. For instance, in 2007 Food and drug administration held a public meeting about generating a “behind the counter” class for drugs—where medication would not be on shop shelves, but could be ordered directly from a pharmacist without the need of a physician’s prescription. In 2009 GAO issued a report on guiding-the-counter medication, which updated GAO’s earlier 1995 report on the similar subject matter.

That explained, there, of training course, could be issues in implementing FDA’s proposed coverage.  One particular significant question could be how to make “conditions for safe and sound and productive use” that perform in the OTC context. In fact, Food and drug administration notes in the draft assistance that “applicants must take into consideration how to guarantee proper implementation of any supplemental affliction needed for safe and sound and productive use.” (For what it is truly worth, the language about candidates ensuring implementation of the situations sounds a bit like the language that Food and drug administration uses in the REMS context.)

Below there could matters to understand from state and local initiatives. As with the federal government, state and local governments have explored means to make sure medication accessible without the need of a physician’s visit—and in some instances, have applied policies to do so.  For instance, in Georgia the state office of community health issued a “standing order” which allows people to acquire naloxone at a pharmacy without the need of an individualized prescription, and California law allows consumers who have applied a self-screening tool to get hold of birth regulate pills directly from pharmacists.  This intersection with state and local initiatives is exciting (to me, anyway), and I’ll be wondering more about it.  But for now, I will basically say, it will be intriguing to enjoy how FDA’s proposed new coverage performs out—and to see regardless of whether any of the state and local methods are adopted at the federal stage.

Patti Zettler is an associate professor at Georgia Condition University University of Regulation, a former CLB fellow, and a Stanford alumna (JD ’09, BA ’02).