You'll love this - Judge Leon says no to TPSAC because of Conflict of Interest!

Status
Not open for further replies.

TennDave

Vaping Master
ECF Veteran
Verified Member
Dec 19, 2010
9,988
8,032
64
Knoxville, TN
As the title says- read it for yourself!!
Alleged Conflict of Interest on FDA Tobacco Panel | Heartlander Magazine

"U.S. District Court Judge Richard Leon has allowed a lawsuit seeking an injunction by R.J. Reynolds and Lorillard tobacco to proceed against the tobacco Products Scientific Advisory Committee. It alleges a conflict of interest on the scientific panel responsible for regulating tobacco products."

"TPSAC was created after passage of the Family Smoking Prevention and Tobacco Control Act. TPSAC has eight member, three of whom allegedly present a conflict of interest with pharmaceutical companies that could benefit from anti-smoking regulations."

"...Drs. Neal Benowitz and Jack Henningfield, both of whom have consulting connections with pharmaceutical companies, to develop smoking cessation products. Benowitz works for Pfizer, the maker of Chantix, a smoking cessation drug. Henningfield consults with the maker of Nicorette gum. A third member of the panel, Dorothy Hatsukami, has received grants to study the effects of a nicotine vaccine."

Dr. Seigel and Tobacco Free Kids are also mentioned in the article.
 
Last edited by a moderator:

TennDave

Vaping Master
ECF Veteran
Verified Member
Dec 19, 2010
9,988
8,032
64
Knoxville, TN
so basically they are stopped from doing anything until the injuction is lifted or the remove them from the panel right?

I would say, that is true in regards to RJR's suit... but probably not in regards to the info that this group will feed the FDA.
Of course, if things don't turn out well, we can site this decision in our argument/suit against the TPSA, and thus the FDA!!
One problem though- we don't have the funds that RJR has to fight these things.
 

Vocalek

CASAA Activist
Supporting Member
ECF Veteran
The comments that are currently being collected by FDA as input for their report to Congress on Section 918 has nothing to do with TPSAC. TPSAC is the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products (CTP). The committee that served as a panel for the Public Hearing in December (and that presumably will be writing the report) was made up mostly of FDA employees that work for the FDA's Center for Drug Evaluation and Research, and included only two CTP employees. That's because one main topic of this report is whether the FDA should approve current Nicotine Replacement Products (NRTs) for long-term use. Those products are not regulated by the CTP. They are still regulated by CDER as drugs -- treatments for "tobacco dependence."

Section 918 of the law also mentions consideration of "innovative products" and products that could be used for smoking reduction or for reducing harm by providing a lower exposure to harmful constituents. I think you can figure out how e-cigarettes might fit into that picture. And the best part is the FDA is being asked to consider creating a "fast track" for approval of such products, which at this point is much better than the complex regulatory structure that the CTP has defined for the designation of "Modified Risk Tobacco Products" under a different section (911) of the law.

So to reiterate, this won't shut down FDA's regulatory efforts. In fact, as I understand the legal situation, the injunction has not yet been granted. Often the first move made by the defendant in a legal case is filing a motion to throw the case out of court. I believe that Judge Leon only ruled on that motion, and decided to allow the case to proceed. Next step would be for the parties to file their arguments (why my side should win). The ruling on the injunction won't happen until after the arguments have been submitted.

The Smoking Everywhere vs. FDA case was filed in March 2009, and the Judge did not make the ruling to grant the injunction until January of 2010. These things take time.
 
Last edited:

JerryRM

Resting In Peace
ECF Veteran
Nov 10, 2009
18,018
69,879
Rhode Island
Cigarbabe, it's really all about money, power and uniformity. This is just the beginning of their "crusade" to make us all think and act alike and live according to their ideals.

I really believe that we are living in dangerous times. Our individuality, our freedom, our right to "life, liberty and the pursuit of happiness", are all in peril.
 
Last edited:

Petrodus

Vaping Master
ECF Veteran
Oct 12, 2010
7,702
8,132
Midwest
Cigarbabe, it's really all about money, power and uniformity. This is just the beginning of their "crusade" to make us all think and act alike and live according to their ideals.

I really believe that we are living in dangerous times. Our individuality, our freedom, our right to "life, liberty and the pursuit of happiness", are all in peril.
When the people fear their government, there is tyranny;
when the government fears the people, there is liberty.
Thomas Jefferson

Our founding fathers warned us about what would happen if we allowed
our elected "criminal" officials run wild ... They were right !!
 
Last edited:

Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
ECF Veteran
Apr 2, 2009
5,171
13,288
66
FloridaNoob inquired:
so basically they are stopped from doing anything until the injuction is lifted or the remove them from the panel right?

NO. Judge Leon merely denied FDA's attempt to quash the lawsuit Reynolds and Lorillard filed against the agency, so the lawsuit continues.

But I'm not aware that Judge Leon has scheduled oral arguments for the case.

Also, please note that Jack Henningfield is no longer on the FDA's TPSAC, but Neil Benowitz is.
 
Status
Not open for further replies.

Users who are viewing this thread