In a draft guidance released Tuesday, the US Food and Drug Administration (FDA) details two proposed approaches to making more drugs available without a prescription.
Under current regulations, nonprescription drugs can come to market either by conforming to an over-the-counter (OTC) monograph or via FDA's new drug application (NDA) process.
To qualify for sale without a prescription, FDA must determine that a drug is safe and effective "under the conditions prescribed, recommended, or suggested in its proposed labeling" without the oversight of a licensed physician.
This is typically done by conducting self-selection studies demonstrating that consumers can interpret and apply the information in the drug facts label (DFL) for the product.
However, in the draft guidance FDA details two new approaches to making nonprescription drugs available in situations where information in the DFL is not sufficient to support OTC use.
Under the first approach, FDA says it could approve additional labeling to ensure the safe and effective use of nonprescription drugs, including leaflets or digital solutions such as software applications or a website.
For the second approach, FDA says it could require additional conditions to ensure safe and effective use, such as requiring consumers to answer a questionnaire or affirm that they have reviewed a video that describes how to appropriately use the product.
FDA Commissioner Scott Gottlieb said the new approaches will help bring more nonprescription drugs, including for some chronic conditions, to market and could help lower healthcare costs.
"Not all prescription drugs can or should be available directly to consumers. Many require a professional diagnosis and oversight to ensure the benefits of use outweigh the risks. But other, select types of drugs, are appropriate for nonprescription use if we are able to ensure access to resources that will help patients determine if the medicine is right for them," he said.
Gottlieb also said that with the new approaches FDA is not lowering its standards for approving drugs for nonprescription use. "As we move into making this a reality, the FDA will ensure that products considered under this framework receive a robust scientific review to ensure they can be used safely by patients," he said.
However, Gottlieb called the draft guidance a "first step" toward expanding the availability of nonprescription drugs and said that FDA is planning to issue a proposed rule clarifying the requirements for marketing nonprescription drugs.
, Federal Register Notice