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Lawmakers ask FDA to reject Philip Morris' iQOS application

By Yasmeen Abutaleb and Tom Lasseter

WASHINGTON/NEW DELHI (Reuters) - Ten U.S. senators called on the Food and Drug Administration to reject Philip Morris International Inc's <PM.N> application to market its iQOS smoking device as being less risky than cigarettes, according to a letter to the agency's commissioner.

The senators, all Democrats, cited remarks by an expert scientific panel that reviewed the application for the U.S. FDA and voted last month against granting Philip Morris permission to do so, according to the letter, a copy of which was seen by Reuters.

They also referred to a Reuters report in December that identified shortcomings in the training and professionalism of some of the lead investigators in the clinical trials submitted to the FDA by the tobacco giant. Former Philip Morris employees and contractors also described irregularities in those experiments.

The world's largest publicly traded tobacco company by market value and maker of Marlboro cigarettes, Philip Morris International has applied to the FDA to be able to sell iQOS in America, and also for permission to market it as a modified-risk tobacco product. That designation could mean that Philip Morris is allowed to sell iQOS to consumers as presenting less harm or risk of disease to users than traditional tobacco.

The senators' letter, dated Feb. 7, asked FDA Commissioner Scott Gottlieb to "avoid rushing through new products, such as IQOS, to fit within this evolving FDA policy, without requiring strong evidence that any such product will reduce the risk of disease, result in a large number of smokers quitting, and not increase youth tobacco use."

It also said: “Such thorough review is especially critical given the tobacco industry’s deceitful history of marketing products under the guise of lower risk.”

The signatories include Elizabeth Warren of Massachusetts, a prominent Democratic voice in the Senate, and five members of the Senate’s powerful appropriations committee, including Dick Durbin of Illinois and Jack Reed of Rhode Island.  

Two senators who signed, Durbin and Richard Blumenthal of Connecticut, released statements to Reuters at the end of last month expressing concern about the iQOS application to the FDA.

Asked for comment at the time, an FDA official said the agency generally cannot comment on a pending product application.

Philip Morris did not respond to the senators’ January remarks. A company spokesman at the time referred to a Jan. 29 statement in which Chief Executive Andre Calantzopoulos said, "We look forward to working with the agency to clarify outstanding points so as to best assist in their ongoing decision-making process, which inherently entails a certain degree of scientific uncertainty pre-market.”

By heating tobacco instead of burning it, the company says iQOS avoids subjecting smokers to the same levels of carcinogens and other toxic substances found in a regular cigarette. The device is part of a $3 billion-plus investment by Philip Morris in new-generation smoking platforms.

Philip Morris is scheduled to release its fourth quarter and full-year earnings reports on Thursday.

Since the first of two days of meetings by the FDA scientific advisory panel on Jan 24, which expressed doubts about Philip Morris’ application to the agency, the company’s stock had fallen about 9 percent as of close of markets on Tuesday.

The panel said Philip Morris had not proven that iQOS reduced harm compared with cigarettes. It did conclude that iQOS exposes users to lower levels of harmful chemicals but said the company had not shown that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death. The recommendation is not binding.

(Editing by Peter Hirschberg)