Live from Gaithersburg: June 8 – 9 2010

NOTE TO READERS: See the ‘Studies and Concepts Under Review” discussion forum to the right of this post to read an advanced copy of the FDA FR notice announcing the June 10 release of guidance on harmful constitutents. Please see CRE comments in the comment section at the end of this post.

NOTE: The public is encouraged to express their views in the “comments” section at the end of this post.

The FDA has supported the use Interactive Public Dockets, although it does not necessarily support their content; if you wish to communicate with the Adivsory Committee in a public forum this is your chance.

Editors Note to FDA

See the first comment below. Is it too late to have tomorrow’s session webcast?


The TPSAC meeting at Gaithersburg is underway. See a relevant article from the New York Times at the end of this post.

If nothing else, the FDA will announce to the public the names of the sub-committee members. After reading the New York Times article maybe there is a reason the FDA did not announce the members of the subcommittee. FDA has just advised CRE that the names of the committee members were posted on TPSAC website Friday afternoon. It is unlikely that in the public comment session watchdog groups such as CRE will have had sufficient time to examine potential conflicts of interest.

The meeting began with the Designated Federal Official stating that the FDA has performed conflict of interest checks on sub-committee members and has determined there are no conflicts.

A Federal Register document will be released for public comment asking the public to give their views on a list of harmful and potential harmful tobacco constitutents as well as criteria for generating the list.

The parent TPSAC commitee, not the subcommitee, will make the final decision on the product and criteria list.

Dr Lauterbachasked why the FDA provided the committee with the biased document prepared by WHO.Dr. Burnsasked why the the sub-committee should develop its own list when other bodies have already done so.Dr. Lauterbach asked what resulted in other countries as result of generating lists of harmful constitutents.

The FDA responded to several of the questions, however to a fair number they stated the questions were out of the scope of this inquiry.

David Burns, MD (UCSD, School of Medicine, Professor Emeritus) (9:00 am) noted that the WHO list of the most hazerdoous tobacco constitutents was not based solely on toxicology per se as the list was developed for regulatory purposes.

— Clifford Watson, Ph.D. (CDC) (11:20am) stated that “we would want to use the best available science to decide this list of harmful constituents.”

— Dr. Burns, (11:40am) stated that animal toxicity data is not a reliable predictor of human toxicity.

–Henningfield (2:10 pm) indicated that “the degree to which menthol may initiate or promote dependence” should be considered in deciding whether it listed as harmful. Response from Burns: We should leave to the parent committee the menthol decision.

— Tully, a representative of the National Tobacco Company, stated (3:10 pm) that the FDA had not established the small tobacco company liasion office required by the legislation

New York Times Article

Group Objects to 2 Members of Tobacco Safety Panel


Published: June 7, 2010

An ethics watchdog group filed a challenge on Monday against two members of a new federal advisory committee for tobacco product safety, saying they should be disqualified because they are consultants for drug companies that make smoking cessation products.

“Everybody hates the tobacco companies, but favoring the drug companies can’t be the answer,” Melanie Sloan, executive director of Citizens for Responsibility and Ethics in Washington, said in an interview after filing the complaint with the inspector general of the Department of Health and Human Services.

She said the two panelists’ ties to smoking cessation businesses would undermine public confidence in regulation of the tobacco industry, which came under the purview of the Food and Drug Administration with the federal tobacco law passed last year.

The same two panelists were the targets of a challenge in March by the Altria Group, owner of Philip Morris, the nation’s largest tobacco company. The F.D.A. rejected Altria’s complaint, saying it had selected qualified members and would manage any potential conflicts case by case as it did on other federal advisory committees. “Tobacco cessation drugs are not regulated by the Center for Tobacco Products,” Meghan Scott, an F.D.A. spokeswoman, said Monday.

The new complaint came as a subcommittee of the panel, the Tobacco Products Scientific Advisory Committee, prepares to meet Tuesday and Wednesday to list the harmful constituents in tobacco products. In July, the full committee plans to consider whether the F.D.A. should regulate or perhaps even ban menthol in cigarettes. The committee also plans to discuss how and whether the F.D.A. should regulate smokeless tobacco products that dissolve in the mouth.

The composition of F.D.A. advisory panels is often a testy issue for companies and activists alike. Because the tobacco center is a new part of the F.D.A., its membership has been under particularly close scrutiny.

One of the panelists, Dr. Neal L. Benowitz, a professor of medicine at the University of California, San Francisco, is a drug industry consultant on treatments to help people stop smoking.

“I really don’t see any conflict,” Dr. Benowitz said Monday. “My involvement with pharmaceutical companies is aimed at reducing the risk of smoking, quitting smoking. The aim of the committee is also to reduce the adverse health consequences of tobacco use.”

Dr. Benowitz was a senior scientific editor of the 1988 surgeon general’s report on nicotine addiction. He consults for Pfizer, makers of Chantix, a prescription pill that aims at nicotine receptors in the brain.

The other panel member challenged by the watchdog group, Jack E. Henningfield, is an addiction expert who holds a share of a patent in a nicotine gum product under development. He did not return messages seeking comment on Monday.

Mr. Henningfield is a vice president at Pinney Associates, a Bethesda, Md., consulting firm for drug companies, including GlaxoSmithKline, makers of nicotine gum, lozenges and patches. He has also worked at the National Institute on Drug Abuse.

Dr. Benowitz and Mr. Henningfield have both testified against tobacco companies in many trials, including a racketeering lawsuit brought by the Justice Department.

In March, Altria sent a 16-page letter of complaint asking the tobacco center to withdraw the appointments of four of the nine voting members of the scientific advisory panel, saying they had “irreconcilable biases.” Altria said Dr. Benowitz and Mr. Henningfield were each currently listed as expert witnesses in more than 100 cases against tobacco makers. Ms. Sloan of the ethics group said the F.D.A. reply to Altria was “incredibly dismissive.” She attached the Altria letter and F.D.A. reply to her own complaint.

“We just thought the financial conflicts were clear,” said Ms. Sloan, a former assistant United States attorney in the District of Columbia. “The F.D.A. has not explained how these are unavoidable conflicts.”

The tobacco law requires that voting members of the advisory panel have no financial ties with tobacco makers. The tobacco industry is represented by three nonvoting members — itself a source of controversy with some antitobacco activists, who say the industry should have no seat at the table.

At least one antitobacco advocate said he thought the challenge by Ms. Sloan’s group was off base.

“They do a lot of good work, but they absolutely got this one wrong,” Stanton A. Glantz, a professor of cardiology at the University of California, San Francisco, said Monday.

“At one level, it’s true the pharmaceutical companies are competing with the tobacco companies. But this is not Coke versus Pepsi,” Professor Glantz said. “The tobacco companies are promoting products that kill half a million people a year. The pharmaceutical companies are trying to promote health.”

Professor Glantz added: “Those are two of the world’s experts, and we need to have people in there who are not going to get snookered by the industry, falling for a bunch of phony pseudoscience. To deny the F.D.A. that expertise would be terrible.”

A version of this article appeared in print on June 8, 2010, on page B3 of the New York edition.

4 comments. Leave a Reply

  1. federal grants

    this post is very usefull thx!

  2. CRE

    The Federal Register Notice states:

    “[the draft guidance] does not create or confer any rights for or on any person and does not operate to bind FDA or the public”.

    All parties should be advised that in the Prime Time decision the DC Circuit Court opined that OMB’s Data [Information] Quality guidelines are binding, see and

    Consequently, CRE will be addressing the impact that both the OMB Data Quality guidelines and its peer review guidelines, issued under the DQA that are not only binding on the FDA but now in all probability are enforceable in court as a result of Prime Time, have on the draft FDA guidelines on harmful constitutents.

    Please consult Tozzi v HHS to review judicial precedent regarding legal action against free standing reports which might be issued pursuant to the FDA harmful constitutents guidance at: and

    In keeping with CRE’s principles of presenting the views of third parties, please read the recent article in the Congressional Quarterly on the CRE Interactive Public Docket for the FDA Advisory Committee at

  3. Tracker

    Seems that tobacco is blazing a new trial at FDA. The argument against these alleged conflicts hinges on “Good Conflicts vs. Bad Conflicts”. These conflicts are good because they are consistent with the mission of the FDA CTP on tobacco regulation. Anyone know of similar examples of where “Good Conflicts” outweigh plain-old conflicts?

  4. cna training

    My cousin recommended this blog and she was totally right keep up the fantastic work!

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