moves to speed nicotine replacement product development
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[November 30, 2017] By
(Reuters) - The U.S. Food and Drug
Administration 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
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.
The new measures could enable e-cigarette companies to get the
devices approved as medical products, which could offer consumers
greater reassurance that they perform as advertised and also open
the possibility of being covered under health insurance.
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.
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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)
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