Philip Morris (PM) presented a persuasive case for its iQOS heat-not-burn product at the first day of the Tobacco Products Scientific Advisory Committee (TPSAC) meeting, according to Wells Fargo Securities, whose representatives attended the gathering.
The meeting, which continues today, was convened by the U.S. Food and Drug Administration (FDA) to help it determine whether to approve PM’s modified risk (MRTP) application for iQOS.
Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the TPSAC should keep in mind four important points as it constructs its recommendation on iQOS:
- The agency’s embrace of a continuum of risk
- The recognition that combustion, not nicotine, is the enemy
- The fact that MRTPA and pre-market tobacco application reviews are separate matters
- The importance of MRTPs to the FDA’s comprehensive nicotine strategy.
Among other topics, TPSAC members asked about PM’s studies on menthol HeatSticks’ appeal to at-risk groups, iQOS’ impact on youth, potential consumer confusion with iQOS’ reduced-exposure claims, relapse rates, and dual-usage.
In Wells Fargo’s view, PM was well prepared with factual and thoughtful responses. The investment bank said it remains cautiously optimistic of a favorable outcome, given the overall quality of PM’s presentations and the evidence it put forth, demonstrating sufficient reduction in harm/risk at the individual and population levels.