The U.S. Food and Drug Administration (FDA) said on Wednesday it is considering measures to speed development of products that help people quit smoking, including easing requirements for approval of over-the-counter nicotine replacement therapies.
The agency said it is “re-evaluating and modernizing” its approach to regulating nicotine replacement therapies (NRT), which are typically sold as gums, patches, and lozenges. Because their effectiveness is limited, the FDA wants to give consumers a wider range of options.
FDA Commissioner Scott Gottlieb said in an interview that the announcement “is a big deal because we haven’t talked a lot about what we can do to create additional pathways to bring additional nicotine replacement therapies to the market.”
Matthew Myers, president of the Campaign for Tobacco-Free Kids, welcomed the initiative.
“Very few NRT products have been cleared in the last decade and very little change has been made to enhance the effectiveness of current NRTs,” he said. “Sending a message that the FDA intends to be open to innovation and that it wants to talk about how to foster that innovation is different from where things have been.”
The announcement is part of a broad nicotine policy outlined by Gottlieb in July aimed at reducing disease and death from traditional cigarettes in part by transitioning smokers over to less harmful nicotine products including e-cigarettes.
Existing NRTs were approved based on studies showing they helped people completely quit smoking for a specific period of time. Gottlieb said there are multiple alternative claims that a company could make that would be easier to prove.
These could include the ability of the product to reduce cravings, help maintain abstinence from cigarettes or address speed of delivery of the nicotine.
Steering a drug through a standard clinical trial process can be expensive and daunting. Gottlieb said he would welcome the opportunity to have discussions with e-cigarette companies about submitting products through the new drug pathway.
“The whole idea here is to better define the policy of demonstrating safety and efficacy of NRTs,” he said.
The FDA has scheduled a public hearing on Jan. 26th
(Reporting by Toni Clarke in Washington; Editing by Cynthia Osterman)