- Food and Drug Administration Commissioner Scott Gottlieb on Tuesday announced a new effort to foster consumer access to medicine by making a broader selection of drug products available without a prescription.
- In a draft guidance, the FDA noted that changing some prescription drugs to over-the-counter products would require input from manufacturers to ensure safety and that consumers are well-informed about them.
- It’s anticipated that drug companies would have to develop additional informative labeling on drug packages, and consumers might have to demonstrate that they are buying an appropriate drug — perhaps through digital apps.
The announcement is the latest in the Food and Drug Administration’s bid to bring down health costs, an effort that so far has included timelier review of generic drug applications. Gottlieb announced in May that the FDA had approved a record number of generic drugs in 2017, providing full or tentative approvals to 1,000 generic drugs.
Changing some prescription drugs for chronic conditions to over-the-counter products would save the healthcare system significant money, and promote easier access to these drugs for consumers, Gottlieb said in a statement.
"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 added. "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," Gottlieb said.
Gottlieb cautioned, however, that any drug that became available without a prescription would need to meet standards for safety, and consumers would need information to help them self-select their medications. One of the ways that consumers could accurately choose medicines would be to pose a series of questions via a technology app — ensuring that the drug is appropriate for the patient’s health condition. The designers of such innovative digital approaches, however, would have to perform studies to demonstrate that the tool would enable consumers to safely use a drug without a prescription.
All drugs changed to over-the-counter products would still need to meet the FDAs "evidentiary standard" for nonprescription drugs, Gottlieb said. As the FDA moves to approve more prescription drugs for over-the-counter sale, they will also be ensuring safety and effectiveness through robust scientific review of data on these medications.
Some examples Gottlieb gave of drugs that could change to over-the-counter products — with additional labeling and education of consumers — would be cholesterol-lowering medications and naloxone, a medicine used to rapidly reverse opioid overdose.
Gottlieb acknowledged that the drug guidance issued Tuesday was just a first step. The effort would also require the FDA to closely collaborate and coordinate with industry and other healthcare stakeholders to strike the right balance between improving access and safeguarding public health, he said.