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 The senators, all Democrats, cited remarks by an expert scientific
panel that reviewed the application for the FDA and voted last month
to recommend against granting Philip Morris permission to do so,
according to the letter, a copy of which was seen by Reuters.
The senators 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 Philip Morris, the maker of Marlboro cigarettes. Former
Philip Morris employees and contractors also described
irregularities in those experiments.
Philip Morris International, the world's largest publicly traded
tobacco company by market value, has applied to the FDA to be able
to sell iQOS in America and for permission to market it as a
modified-risk tobacco product. That designation could mean that
Philip Morris would be allowed to sell iQOS to consumers as
presenting less harm or risk of disease than traditional tobacco.
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 regular cigarettes. The device is
part of a $3 billion-plus investment by Philip Morris in
new-generation smoking platforms.
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, a prominent Democratic
voice in the Senate, and five members of the Senate’s powerful
appropriations committee, including Dick Durbin and Jack Reed.
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Durbin and Senator Richard Blumenthal, who also signed the letter,
released statements to Reuters at the end of last month expressing
concern about the iQOS application to the FDA.
An FDA official said on Wednesday the agency had received the letter
and would respond directly to the senators.
Philip Morris did not immediately respond to requests for comment. A
company spokesman 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.”
The advisory 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.
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 has fallen
about 9 percent as of the market's close on Tuesday. The stock was
down 0.7 percent Wednesday afternoon.
Philip Morris is scheduled to release its fourth-quarter earnings
report on Thursday.
(Additional reporting by Duff Wilson in New York; Editing by Peter
Hirschberg and Leslie Adler)
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