FDA Looks to Ease Restrictions on Some Prescription Drugs

Commissioner Scott Gottlieb says the proposal would improve competition, expand access, empower consumers, and provide more affordable options.

The Food & Drug Administration is floating new guidelines that would lift restrictions on some prescription drugs and make them available to consumers over the counter.

"We're very mindful of the time and financial cost to patients and the healthcare system to fill a prescription medicine—particularly one taken repeatedly for chronic conditions," FDA Commissioner Scott Gottlieb, MD, said in a media release.

"Our hope is that the steps we're taking to advance this new, more modern framework will contribute to lower costs for our healthcare 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," he said.

• Gottlieb said the proposed rule "will clarify the requirements for a drug that could be marketed as a nonprescription drug with a requirement that ensures appropriate self-selection by consumers, appropriate actual use, or both, in order to obtain the drug without a prescription."
   
• The over-the-counter access could include cholesterol-lowering drugs, and Naloxone, the opioid effects blocker sold under the brand names Narcan and Evzio.
   
• Digital technologies, such as cell phone apps, could be used to help consumers understand the appropriate use and dosage for the drugs, the potential side effects, and possible interactions with other drugs or alcohol.  
   
• Gottlieb said the proposed guidelines apply to drugs under the FDA's New Drug Application process "and is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription."
   
• If consumer safety requirements can be demonstrated under the new guidelines, Gottlieb said drug makers could apply for nonprescription status.

"We see today's draft guidance as a first step as drug developers begin to study products that might be considered for marketing without a prescription," Gottlieb said. "We intend to continue this effort with proposed rulemaking in the near future and will provide additional information as we move forward."