FDA Says Tech Can Open Up Access to Prescription Drugs

Apps and other tools can ensure the safety of medications that typically require a prescription, the commissioner said.

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Imagine downloading an app, answering a series of questions, and gaining access to a medication that is otherwise gated to the public by way of a prescription. In 2018, that could become the new reality, according to the FDA.

The agency’s commissioner, Scott Gottlieb, MD, described the idea in a blog post this week outlining the FDA’s policy goals for the upcoming year. Although much of his agenda focused on healthcare goals outside the digital realm, Gottlieb invoked technology, mobile health, and data-sharing when he described his desire to empower patients by providing better drug information and expanding access to over-the-counter meds.

“Consumers tell us that they want this information,” he wrote. “We also know that consumers who have access to more diverse, safe, and effective options—and who have improved information about those choices—make better, more cost-effective decisions.”

Specifically, the agency intends to consider widening the group of medications that patients may access without a prescription. Gottlieb plans to propose regulations green-lighting “certain innovative approaches” to make this happen. One such example is a medical app that administers self-selection questions to potential consumers as a condition of drug availability, he said.

“Through the use of these types of additional conditions, we hope to create a new paradigm of drug safety with greater flexibility that will benefit patients and public health,” the commissioner wrote, noting that the arrangement could enable patients to self-treat common and chronic conditions. “This also could help lower costs by increasing the availability of products that would otherwise be available only by prescription.”

The move would ultimately OK marketing for medications that often require a prescription, he said.

The FDA also wants to give patients more information regarding their drugs, delivered in a “consistent and easily understood format,” each time they visit the pharmacy. The big-picture goal? Gottlieb and his team hope to enable patients to make “high-value decisions,” using drugs safely and effectively.

Although the commissioner did not mention how technology might play into this effort, private healthcare organizations have grown more interested in providing medication information at the point of care, both in the prescriber’s office and the pharmacy. Giants like CVS Health and Surescripts, for example, are making strides in delivering real-time data on drug prices, deductibles, and therapeutic alternatives.

In 2017, Gottlieb and the FDA have steered groundbreaking advances in health technology. The agency launched a precertification pilot program designed to accelerate approvals for healthcare software, bringing on companies like Apple, Fitbit, and Johnson & Johnson as partners. The FDA also approved the first “digital pill,” promoted medical device innovation, and endorsed huge steps forward for precision medicine.