FDA Awards $40 Million Tobacco Product Policy Research Contract To SciMetrika

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U.S. Federal Drug Administration Awards $40 Million Tobacco Product Policy Research Contract To SciMetrika

SciMetrika’s research findings could influence a range of policies, including regulations related to electronic cigarettes or flavored tobacco products.

Anyone know anything about this company aside from what they post on their website?

 

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Full text of press release

U.S. Federal Drug Administration Awards $40 Million tobacco Product Policy Research Contract To SciMetrika

Population Health Consulting Firm's Findings May Influence Regulation Of Popular tobacco Products Like Electronic Cigarettes

DURHAM, N.C., Sept. 30, 2013 – SciMetrika, LLC, a population health consulting firm, has announced that the company has been awarded a $40 million, Indefinite Delivery/Indefinite Quantity (IDIQ) single-award contract by the Federal Drug Administration (FDA) to research and analyze the feasibility of various policy options for regulating certain tobacco products. SciMetrika’s research findings could influence a range of policies, including regulations related to electronic cigarettes or flavored tobacco products.


Under the terms of the contract, SciMetrika will be responsible for assembling a team of multidisciplinary public health professionals who will collect and synthesize evidence concerning tobacco products and inform the development of regulatory policy options to the FDA’s Center for Tobacco Products (CTP).


The contract will span five years. Project work began in September 2013.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave the FDA authority to regulate tobacco products. CTP’s responsibilities for implementing the Family Smoking Prevention and Tobacco Control Act include:

- Setting performance standards

- Reviewing premarket applications for new and modified-risk tobacco products

- Proposing and implementing new cigarette pack warning labels

- Eliminating flavor additives (except menthol) in cigarettes

- Investigating and ruling on the possible elimination of menthol flavoring in cigarettes

- Proposing a plan to regulate other tobacco products, such as cigars and smokeless tobacco

- Establishing and enforcing advertising and promotion restrictions


SciMetrika will consult with other companies as well as subject matter experts from schools of public health at leading universities to offer augmented expertise and services in specialized areas. The organizations include Gesellschaft für Konsumforschung (Society for Consumer Research), Abt SRBI, the University of North Carolina at Greensboro and JBS International, Inc.

QUOTES:

“We are excited to work with the FDA’s Center for Tobacco Products to assist in the development of regulatory policy options,” said Dr. Michael Samuhel, SciMetrika director of population health sciences. “We are looking forward to sharing our findings with the FDA and CTP and to doing our part in eliminating tobacco-related disease and mortality.”

“We are excited for the opportunity to provide research and present evidence to the FDA Center for Tobacco Products on this project,” said SciMetrika CEO Dr. Jean Orelien. “SciMetrika’s staff understands the special attention required for an initiative as important as the regulation of tobacco products. We look forward to serving the FDA using our deep knowledge of population health.”

ABOUT SCIMETRIKA:

SciMetrika, LLC is a fast-growing, privately held business with a singular focus on advancing human health. Founded in 2001, the company serves public and private sector clients seeking to understand and influence population health outcomes. SciMetrika's multidisciplinary teams, mature business processes and unwavering focus on advancing human health allow SciMetrika to offer wide-ranging services that are unmatched by other businesses in this market space. For more information, please visit scimetrika.com or call (919) 354-5200.

 

[oplholik]

40 MILLION DOLLARS!!
I wonder if they will find e-cigs a lot safer than cigs, or if they will go with what the FDA, and who pays them, wants to hear.

 

[scalewiz]

It's all regulatory BS! Nothing but BS! The only thing this company is out for is a buck. They will say anything they need to say to get another money grant. BS!

 

[pamdis]

Read these two pages on their website. Looks like they don't actually do any research - just help their "customers" acheive their goals:

SciMetrika

SciMetrika capabilities in statistics and epidemiology

Nothing there about finding the actual truth and presenting an unbiased report.

 

[Petrodus]

40 MILLION DOLLARS!!
I wonder if they will find e-cigs a lot safer than cigs, or if they will go with what the FDA, and who pays them, wants to hear.

People have sold their souls for a lot less

 

[Uma]

This says it all: SciMetrika will consult with other companies as well as subject matter experts from schools of public health at leading universities to offer augmented expertise and services in specialized areas ( of Glantz school of epidemiology).

 

[cookiebun]

This says it all: SciMetrika will consult with other companies as well as subject matter experts from schools of public health at leading universities to offer augmented expertise and services in specialized areas ( of Glantz school of epidemiology).

Consulting Demotivator® - Demotivational posters from Despair.com

 

[flowerpots]

This same company was awarded a 1.5 million contract with the CDC back in September for a 36 month infectious disease tracking contract.

"The firm's customers include many federal research and public health agencies, such as the Centers for Disease Control and Prevention (CDC), the National Institute of Environmental Health Sciences (NIEHS), the Food and Drug Administration (FDA), and the U.S. Department of Veterans Affairs (VA). "

"Durham, NC, July 02, 2013 --(PR.com)-- SciMetrika, LLC (http://www.scimetrika.com), a population health consulting firm, has announced the hiring of Dea Zullo as director of bids and proposals. In her new role, Zullo will be responsible for driving operational efficiencies and infusing strategic value into the bids and proposals lifecycle for SciMetrika. Prior to joining SciMetrika, Zullo served as director of business and proposal development in the research computing division at RTI International. During her 13-year tenure, she led proposal efforts, negotiated partnerships, trained and mentored staff on capture and proposal development developed marketing materials and helped the firm garner positions on several government-wide IDIQ vehicles and GSA schedules. She received her Master of Arts in experimental psychology with a minor in neuroanatomy from Duke University, and has received numerous certifications from Shipley Associates and related industry organizations."

 

[JulesXsmokr]

So who says the e-cig is tobacco product? On what legal grounds do they have a right to call it so?
Who really gets to categorize it so?
A tobacco product is a leafy, chemically laden addictive product.
What about the nic. gum, and patches, those are pharma drugs right?
I could be wrong but, who really has the legal authority to call it night and day?

 

[Psyche]

There was a court ruling about it. Summed up here a bit - CASAA: E-Cigarettes: Rush To Regulate Could Destroy Effective Alternative

In 2009, four of the organizations that signed last week's letter--the Campaign for Tobacco-Free Kids, the American Lung Association, the American Cancer Society Cancer Action Network, and the American Heart Association--jointly pressured the FDA to remove electronic cigarettes (e-cigarettes) from the market. The FDA tried to do so until a Federal Court Judge ruled that e-cigarettes cannot be regulated (and thus banned) as a drug unless therapeutic claims are made.

In the court ruling Judge Leon said the FDA had authority to regulate e-cigs as a tobacco product. Had it been ruled a drug delivery device, the pioneer vapers in 2009 would have been cut off and me and you probably still wouldn't know anything about them.
Unless BigPharm demanded rapid approval of their e-cig that they would probably have come up with if the ban had stuck.

The whole case began with the FDA seizing shipments of vape stuffs at customs.

CASAA Smoking Everywhere vs. FDA

 

[NorthOfAtlanta]

Why do I feel like the FDA just bought themselves a $40 million dollar ANTZ hill?

 

[pamdis]

So who says the e-cig is tobacco product? On what legal grounds do they have a right to call it so?
Who really gets to categorize it so?
A tobacco product is a leafy, chemically laden addictive product.
What about the nic. gum, and patches, those are pharma drugs right?
I could be wrong but, who really has the legal authority to call it night and day?

The FDA has the authority. My understanding is that is what we are waiting for this month - for them to deem (define) e-cigs a tobacco product. Once they do that, then they will have the authority to regulate them. Oct will be deeming month, regulations to follow...

 

[Petrodus]

Why do I feel like the FDA just bought themselves a $40 million dollar ANTZ hill?

The FDA is still ticked-off about losing their case in court to ban the sale of e-cigarettes
and has been planning for the upcoming fight for a long doing everything possible
to insure they are bullet proof when releasing their proposed demon regulations.

 

[NorthOfAtlanta]

The FDA is still ticked-off about losing their case in court to ban the sale of e-cigarettes
and has been planning for the upcoming fight for a long doing everything possible
to insure they are bullet proof when releasing their proposed demon regulations.

This group sounds more like a PR/polling firm than a research organization. I'm thinking their first question is what results do you need?

 

[Petrodus]

The table is tilted folks ... The game is rigged.
George Carlin

 

[Exhaler]

This group sounds more like a PR/polling firm than a research organization. I'm thinking their first question is what results do you need?

I suspect they are just going to gather available data and launch a summary of actions the FDA can use. Since it sounds like they are already anti-tobacco, the report is probably already completed. What a frickin waste of our money being spent by anti-tobacco whiners.

 

[AgentAnia]

This group sounds more like a PR/polling firm than a research organization. I'm thinking their first question is what results do you need?

They probably awarded this $40 million contract to SciMetrika to coordinate and report on the efforts of the 14 new cost-us-$53-million Tobacco Centers of Regulatory Science (TCORS) they announced two weeks ago.

$93 million and counting...

 

[Uma]

Epidemiological studies can only go to prove that an agent could have caused, but not that it did cause, an effect in any particular case.

We, the people, can do a vape march to show them exactly what could means and what did means.
We somehow need to get the ridiculous news out to the public. They are spending millions of taxpayers monies to prove a " could, maybe, perhaps," instead of to real labs and scientists like dr. Farsalinos and dr, Byrnstein (sp) and other non- biased scientific based factual studies.
I could turn into a fairy princess tomorrow by vaping, or I could turn into a toad. I want to KNOW my future, not guess at could bes.

 

[altspeed]

Is anyone else concerned about the phrase "synthesize evidence" that would basically mean inferring evidences that don't exist

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