WASHINGTON – The U.S. Food and Drug Administration says it’s willing to increase over-the-counter access to some medications to treat common and chronic conditions, if there are resources in place, like digital health technologies, to determine if the treatment is appropriate.
In a statement, Dr. Scott Gottlieb, FDA Commissioner, said the FDA’s approaches could include applying digital health technologies like mobile apps that would support consumers in appropriately and safely self-selecting and using certain drugs.
“While the FDA doesn’t have a direct role in the cost of medicines, we’re very mindful of the time and financial cost to patients and the health care system to fill a prescription medicine—particularly one taken repeatedly for chronic conditions,” he said. “Our hope is that the steps we’re taking to advance this new, more modern framework will 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.”
The agency has drafted guidance that lays out a process whereby a sponsor—for example, a company that has a prescription drug—could develop a mobile app that increases the likelihood of correct self-selection and accurate use of the product in the nonprescription setting. After demonstrating through studies that consumers can safely use the drug without a prescription and with associated supervision of a health care professional, the sponsor could submit an application for FDA consideration for nonprescription status for the product.
“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,” Gottlieb said. “Our ultimate goal with modernizing our regulatory framework for nonprescription drugs is to help facilitate a market that is more competitive, enables greater access to medical products, empowers consumers in their health care decisions, and provides more affordable options for Americans.”