FDA announces TPSAC meeting on April 30 on MRTP

[Bill Godshall]

Looks like another road trip to DC.

The April 30 TPSAC meeting will be on MRTPs, and TPSAC will meet behind closed doors (from 3:30-5:30) to apparently consider the first MRTP application (presumably from Altria, Swedish Match or Reynolds).
http://www.gpo.gov/fdsys/pkg/FR-2013-04-08/html/2013-08069.htm

Agenda: Modified risk tobacco products (MRTPs) are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Before an MRTP can be introduced or delivered for introduction into interstate commerce, an order fromFDA under section 911(g) (21 U.S.C. 387k(g)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must be in effect with respect to the tobacco product. 21 U.S.C. 387k(a). Any person may submit an application seeking an order under section 911(g) of the FD&C Act.

Section 911(f) of the FD&C Act (21 U.S.C. 387k(f)) requires FDA to refer modified risk tobacco product applications to the Tobacco Products Scientific Advisory Committee (TPSAC) for its recommendations. TPSAC is required to report its recommendations on an application to FDA no later than 60 days after the date the application is referred to them. 21 U.S.C. 387k(f)(2). On April 30, 2013, FDA will present information to the committee on the process it will use to refer individual modified risk tobacco product applications to TPSAC.

Procedure: On April 30, 2013, from 8:30 a.m. to 3 p.m., the meeting
is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person on
or before April 23, 2013. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 12 noon on April 30, 2013.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
April 15, 2013.

Closed Committee Deliberations: On April 30, 2013 from 3:30 p.m. to 5:30 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)).

 

[Berylanna]

I'd like to see someone there who can truthfully and credibly promise not to reveal any trade secrets they hear in the meetings, otherwise we'll miss too much. I assume there would be an NDA to sign?

 

[Bill Godshall]

Please note that the sign-up deadline for testifying at the April 30 TPSAC meeting is Monday, April 15.

If you plan to attend and testify at the April 30 TPSAC meeting, send an e-mail to Caryn Cohen at TPSAC@fda.hhs.gov
requesting to present. Below is the e-mail I sent her today.

Subject: Request for oral presentation at April 30 TPSAC meeting

Per the Federal Register notice at:
Federal Register, Volume 78 Issue 67 (Monday, April 8, 2013)
I would like to make an oral presentation to TPSAC on the scientific evidence of different morbidity and mortality risks attributable to the use of different tobacco products, FDA's claims about disease risks attributable to different tobacco products, and the MRTP application and approval process at the April 30 TPSAC meeting.

Fifteen minutes should suffice for my comments.

Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com