Philip Morris International (PM) lost two important U.S. Food and Drug Administration (FDA) committee votes on its smoke-free device this week, but Wells Fargo remains optimistic that the product’s MRTP application could receive approval because the product is in line with agency’s plan for a comprehensive nicotine strategy.
As reported by Investor’s Business Daily, The Tobacco Products Scientific Advisory Committee ruled the PM’s smoke-free tobacco delivery device IQOS should not be allowed to be marketed as being less harmful than continuing to smoke cigarettes.
The FDA’s Tobacco Products Scientific Advisory Committee voted 8-0 with one abstention against Philip Morris’ claim IQOS cuts the risk of tobacco-related diseases, and in a 5-4 vote rejected its claim that it is less risky than continuing to smoke cigarettes.
However, the panel did vote 8-1 in favor of the firm’s claim IQOS reduces the body’s exposure to harmful or potentially harmful chemicals. The panel then ruled 5-2 against the claim that these reductions in exposure are reasonably likely to translate to a measurable and substantial reduction in morbidity and or mortality, Investor’s Business Daily pointed out.
Wells Fargo weighed in on what this means for the product’s future. “While so far the votes by the Tobacco Products Scientific Advisory Committee (TPSAC) have been broadly opposed to PM’s modified-risk application for IQOS (the majority of the panel has voted “No” in three out of four questions posed to it so far on health risk/exposure labeling/advertising for iQOS) – we don’t view today’s events as a total disaster given: (1) much of the panel’s concerns were around how PM worded it’s proposed reduced risk claims and how PM “messages” those claims to the consumer (we’re hopeful there is room for PM & the FDA to work on this); (2) the TPSAC’s recommendation to the FDA is non-binding; and (3) the FDA, we think, seems more supportive of ultimately approving PM’s MRTP application as it is in line with agency’s plan for a comprehensive nicotine strategy,” said Wells Fargo Senior Analyst Bonnie Herzog.
“We note, however, the Panel’s seeming dissatisfaction with PM’s data on topics such as youth initiation, impact on vulnerable populations, and in support of some of the claims as currently worded. Therefore, we wouldn’t be surprised if more data/research is requested to more effectively demonstrate the science to support the claim that switching to IQOS from combustible cigs definitively reduces risk of disease & exposure to harmful toxins, i.e., it’s a process. Ultimately, we think the chances for the FDA to approve PM’s MRTP are still good, but timing is tough to predict,” Herzog added.
What happens next? Herzog explained that the panel will vote on the remaining issues around consumer comprehension of IQOS’ claims. Then the FDA will continue its review. Herzog pointed out that it took the FDA approximately 20 months to issue its final decision (denied) on Swedish Match’s MRTP application.
“We continue to expect premarket (PMTA) approval of IQOS and continue to believe this could be in the next few months. We believe the market has over-reacted to today’s events…” Herzog added.