Viewpoints Cover The Waterfront At FDA Nicotine Replacement Therapy Policy Hearing

FDA added to the docket for its initiative evaluating nicotine replacement therapies reference materials including a meta-analysis on efficacy of NRTs in smoking cessation and a report on quitting smoking among adults in the US, 2000-2015.

Speakers scheduled for a Jan. 26 public hearing on FDA's approach to evaluating nicotine replacement therapies represent a gamut of views. from an executive with a US tobacco product manufacturer to the president of a leading smoking-prevention advocacy group.

FDA on Jan. 19 posted an agenda for the hearing it announced in November. It also has added to the docket for the initiative reference materials including a meta-analysis on nicotine replacement therapy efficacy in smoking cessation and a report on quitting smoking among adults in the US, 2000-2015.

Speakers on the agenda for the meeting at FDA's White Oak campus headquarters in Silver Spring, Md., also include executives from the manufacturer of Harmless Cigarettes, which do not contain nicotine or tobacco and are not electronic devices, firms making conventional products approved by FDA as nicotine replacement therapies (NRTs) and an electronic cigarette marketer that is a subsidiary of a firm that challenged FDA's attempted ban of e-cigarettes.

Charles Garner will speak on “Product and Process Considerations for Emerging NRT Products” during the hearing for RAI Services Co., launched in 2016 by Reynolds American Inc. to manage sales, distribution and retail/wholesale strategies for all its divisions. Like other large tobacco firms, Reynolds American markets products in the "electronic nicotine delivery systems" (ENDS) space, through its R.J. Reynolds Vapor Co. business.

Smoking-prevention advocates are represented on the agenda by Matthew Myers, Campaign for Tobacco Free Kids president. Myers presentation is “Nicotine Replacement Therapies: The Need for a New Regulatory Approach.”

Consumer health advocates also are represented among the speakers by Erika Sward from the American Lung Association. She will present ALA's "Comments on FDA’s Approach to Nicotine.”

In addition to speakers from NRT product marketers GlaxoSmithKline PLC, Johnson & Johnson and Intratab Labs Inc., the OTC drug industry is represented by Consumer Healthcare Products Association policy chief and general counsel David Spangler.

Harm Reduction Advocated

The National Center for Public Policy Research, an independent conservative think-tank, will offer comments on “NRT in a class by itself: Do the ENDS justify the means.” The center's representative is Jeff Stier, who has urged FDA to move more toward harm reduction in its approach for evaluating NRTs, including allowing therapeutic claims for electronic cigarettes and other ENDS.

When FDA in July 2017 announced a review of its tobacco product standards, Stier stated, "The FDA will now begin to develop new rules which will recognize that non-combustible lower-risk products such as e-cigarettes and next generation 'heat not burn' products should no longer be treated solely as public health threats.

"The FDA will instead embark on a rule-making process whereby the products will be regulated based on their risk profile. This approach, if implemented properly, will foster a robust market offering a range of options to smokers who wish to reduce the risk from smoking," Stier said in a statement.

Harm reduction also has been argument promoted by the e-cigarette firm represented at the hearing, NJOY Innovations Ltd. NJOY is a London subsidiary of US firm Sottera Inc., which was a plaintiff in a complaint that led to a federal court ruling in 2010 that barred FDA from regulating e-cigarettes as medial products unless they make a health claim. (Also see "Federal court lifts import ban on e-cigarettes" - Pink Sheet, 18 Jan, 2010.)

FDA had ordered a halt to e-cigarette sales in 2009 after laboratory analyses revealed carcinogens and toxic chemicals in samples of two brands. (Also see "FDA Warns Electronic Cigarettes Pose Public Health Risk" - Pink Sheet, 27 Jul, 2009.)

FDA later brought ENDS, other novel nicotine products, premium cigars and pipe tobacco under its authority established by the Family Smoking Prevention and Tobacco Control Act of 2009, however the effective date of that oversight has been delayed as the agency reviews its tobacco product standards.

Neither an FDA announcement or its Federal Register notice for the public hearing explicitly identified ENDS as potential NRTs, but the agency said delivery formats other than the currently approved gums, patches and lozenges are on its radar. (Also see "FDA's Nicotine Replacement Standards Review Could Open Door For E-Cigarettes" - Pink Sheet, 29 Nov, 2017.)

On the same day, FDA also announced a Nicotine Steering Committee, headed by Commissioner Scott Gottlieb, to re-evaluate and modernize FDA’s approach to the development and regulation of NRTs. The committee's primary focus will be development and approval of additional NRTs to help smokers stop using combustible tobacco products. FDA's drug center and tobacco products center directors and other senior agency officials also are on the committee.

The hearing will be chaired by Rachel Sherman, who was named FDA's principal deputy commissioner in August, moving from deputy commissioner for medical products and tobacco. (Also see "Gottlieb Adds A No. 2: Sherman Is US FDA Principal Deputy Commissioner" - Pink Sheet, 21 Aug, 2017.)

The comment period for FDA's initiative, docket FDA-2017-N-6529, is open.

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