Lawmakers ask FDA to reject Philip Morris’ application for its iQOS smoking device

Ten U.S. senators called on the Food in addition to Drug Administration to reject Philip Morris 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 which reviewed the application for the U.S. FDA in addition to 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 which identified shortcomings within the training in addition to professionalism of some of the lead investigators within the clinical trials submitted to the FDA by the tobacco giant. Former Philip Morris employees in addition to contractors also described irregularities in those experiments.

the earth’s largest publicly traded tobacco company by market value in addition to maker of Marlboro cigarettes, Philip Morris International has applied to the FDA to be able to sell iQOS in America, in addition to also for permission to market which as a modified-risk tobacco product. which designation could mean which Philip Morris is actually 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 fresh products, such as IQOS, to fit within which evolving FDA policy, without requiring strong evidence which any such product will reduce the risk of disease, result in a large number of smokers quitting, in addition to not increase youth tobacco use.”

which also said: “Such thorough review is actually 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 within the Senate, in addition to a few members of the Senate’s powerful appropriations committee, including Dick Durbin of Illinois in addition to Jack Reed of Rhode Island.

Two senators who signed, Durbin in addition to 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-doing process, which inherently entails a certain degree of scientific uncertainty pre-market.”

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

Philip Morris is actually scheduled to Discharge its fourth quarter in addition to 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 the close of markets on Tuesday.

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

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