Opening Up the OTC Market

Cross-posted on Stanford’s Law and the Biosciences Blog

Yesterday, FDA announced a new draft guidance “Innovative Approaches for Nonprescription Drug Products” intended to expand the range of drugs available over-the-counter (OTC). Specifically, the agency’s proposal indicates a willingness to make available OTC drugs for certain historically prescription-only therapeutic categories—such as overdose reversal drugs, like naloxone, or cholesterol-lowering drugs. As I told a journalist yesterday, overall I see this as a positive step—and one that is consistent with long-standing interest in making more drugs available without a visit to a physician, including interest at the state and local level.

OTC drugs generally get to market through one of two routes—they are marketed (1) pursuant to an OTC monograph (a regulation that, essentially, sets out the conditions that a company can follow to market its drug without obtaining FDA’s premarket approval) or (2) under an approved new drug application.  The new draft guidance applies to those drugs that are (or would be) marketed under a new drug application.

FDA is not proposing to change its standard for approving applications for OTC drugs. A manufacturer still must show that its drug’s benefits outweigh risks in the OTC context, considering, for example, whether consumers can self-diagnose their condition, whether consumers can tell whether the drug is working for them, whether consumers can understand how to use the drug, and the severity of the risks associated with the drug.

Instead, FDA is suggesting that there may be innovative ways—through additional labeling or “conditions for safe and effective use”—to ensure that a wider range of drugs have benefits that outweigh their risks in the OTC context. For example, perhaps a quiz on a mobile app could help consumers identify whether a particular drug is right for them.  The hope is that making more drugs available OTC will increase patient access—because OTC drugs would be lower cost and there would be fewer logistical obstacles to getting OTC drugs (e.g., there is no need to schedule and go to a doctor’s appointment for a prescription).

The new draft guidance is consistent with long-standing interest in expanding patients’ options for accessing drugs without a visit to a physician. For example, in 2007 FDA held a public meeting about creating a “behind the counter” category for drugs—where drugs would not be on store shelves, but could be purchased directly from a pharmacist without a physician’s prescription. In 2009 GAO issued a report on behind-the-counter drugs, which updated GAO’s earlier 1995 report on the same topic.

That said, there, of course, may be challenges in implementing FDA’s proposed policy.  One big question may be how to create “conditions for safe and effective use” that work in the OTC context. Indeed, FDA notes in the draft guidance that “applicants should consider how to ensure proper implementation of any additional condition necessary for safe and effective use.” (For what it’s worth, the language about applicants ensuring implementation of the conditions sounds a bit like the language that FDA uses in the REMS context.)

Here there may things to learn from state and local initiatives. As with the federal government, state and local governments have explored ways to make certain drugs available without a physician’s visit—and in some instances, have implemented policies to do so.  For example, in Georgia the state department of public health issued a “standing order” which allows individuals to purchase naloxone at a pharmacy without an individualized prescription, and California law allows consumers who have used a self-screening tool to obtain birth control pills directly from pharmacists.  This intersection with state and local efforts is interesting (to me, anyway), and I’ll be thinking more about it.  But for now, I will simply say, it will be fascinating to watch how FDA’s proposed new policy plays out—and to see whether any of the state and local approaches are adopted at the federal level.

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