FDA Announces Draft Guidance for Consumer OTC Access to Previously Prescription Drugs

According to a recent news article published in JAMA,¹ the US Food and Drug Association (FDA) has issued a draft guidance for helping prescription medications gain approval for nonprescription status.

The FDA draft guidance² details how manufacturers can progress a prescription-only product to approval to nonprescription status. Doing so can help patients obtain prescription medications without requiring the prescription. According to FDA Commissioner Scott Gottlieb, MD, the new model may “contribute to lower costs for our health care system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription.”³

One strategy drug manufacturers can use to obtain nonprescription status for prescription-only drugs would be to introduce additional labeling with the product or on online mediums. An additional method would entail specific consumer requirements, which might be assessed by a mobile patient questionnaire in an effort to determine whether they are appropriate candidates for the nonprescription medication.

In an FDA press release,³ Dr Gottlieb noted that these approaches include “applying innovative tools, like digital health technologies, that would support consumers in appropriately and safely self-selecting and using certain drugs.”

“Nonprescription drug products are used by consumers without the supervision of a health care professional and require a very high safety margin that takes into consideration the potential consequences of inappropriate use,” said Dr Gottlieb. “As we look at expanding the types of products available without a prescription, the safety of patients remains a top priority.”

1. Voelker R. No prescription needed? JAMA. 2018;320(7):634.

2. US Food and Drug Administration. Innovative approaches for nonprescription drug products. Guidance for industry.  https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613666.pdf. Published July 13, 2018. Accessed September 25, 2018.

3. Statement from FDA Commissioner Scott Gottlieb, MD, on new efforts to empower consumers by advancing access to nonprescription drugs [news release]. Silver Spring, MD: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm. Published July 17, 2018. Accessed September 25, 2018.