VTA v. FDA Litigation Update

ERIC N. HEYERTHOMPSON HINE LLP

DisclaimerThe information presented is for educational and informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem discussed during this presentation. Participation in this presentation does not create an attorney-client relationship between Thompson Hine LLP and you. The opinions expressed during this presentation are the opinions of the individual author.

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Background: Why is litigation necessary?

August 8, 2016: Deeming Rule take effect.Ø Provides 24-month deadline (August 8, 2018) for filing

PMTAs.

May 5, 2016: Draft Guidance on PMTAs for ENDS published.

Ø Includes “recommendations” that are “non-binding.”Ø Invites public comment for revisions.

Background: Why is litigation necessary?July 28, 2017: Commissioner Gottlieb announces Comprehensive Plan for Nicotine and Tobacco

Ø Postpones August 8, 2018 PMTA deadline to August 8, 2022.Ø Promises to pursue a regulation regarding PMTAs for ENDS.Ø Director Zeller emphasizes importance of public input to

ensure “agency has the proper science-based policies in place.”Ø FDA press release says agency “intends to issue regulations

outlining what information the agency expects to be included in” PMTAs.

Background: Why is litigation necessary?March 27, 2008: Maryland federal court lawsuit filed against FDA

ØPlaintiffs include American Academy of Pediatrics, Campaign for Tobacco Free Kids, American Lung Association, American Heart AssociationØComplaint seeks ruling that extension of PMTA compliance

deadline was ultra vires and contrary to Administrative Procedure ActØPlaintiffs seek to remove all vapor products from market

Background: Why is litigation necessary?July – August 2018: cross-motions for summary judgment filedMarch 26, 2019: Maryland federal court denies Plaintiffs’ motion for summary judgment without prejudiceApril 2, 2019: Plaintiffs file motion for reconsideration

Background: Why is litigation necessary?May 15, 2019: Maryland federal court grants Plaintiffs’ summary judgment motion Ødeclares FDA acted unlawfully in extending PMTA deadline to

August 2022 (ultra vires and lack of notice and comments under APA)Øinvites supplemental briefing on appropriate remedy

Background: Why is litigation necessary?June 12, 2019: FDA files remedy brief

Ø argues Court must remand issue back to agencyØ responds to Plaintiffs’ proposed 4-month PMTA deadline by

stating that sudden removal of vapor products from market could precipitate a “public health crisis”

Ø but then goes on to suggest an alternative 10-month PMTA deadline

July 12, 2019: Maryland federal court orders 10-month PMTA deadline with May 11, 2019 filing deadline

Background: Why is litigation necessary?Meanwhile, FDA has continued to promise a PMTA foundational rule, finalized guidance, and GMPs.

Ø “The foundational regulations for the tobacco program were never put in place and so we’re going to take the time to put those in place.” (Gottlieb, 11/3/17.)

Ø “[W]e plan to issue a series of foundational rules and guidance documents that will delineate key requirements of the regulatory process, such as . . . the submission of applications for new tobacco products.” (Gottlieb, 3/15/18.)

Ø “Foundational proposed rules” are needed “regarding the basic rules of the road, especially when it comes to what’s expected in premarket applications.” (FDA, 8/2/18.)

Background: Why is litigation necessary?Meanwhile, FDA has continued to promise a PMTA foundational rule, finalized guidance, and GMPs.

Ø Gottlieb testifies before Congress that extension until August 2022 was necessary “to give [FDA] the time to put in place the implemental regulations and guidance that would . . . provide the rules of the road for how to effectively traverse the PMTA process.” (2/27/19.)

Ø But, mere weeks later, along with publication of March 2019 Draft Flavors Guidance, FDA states that it wants to prompt manufacturers to move up their filing of PMTAs.

Background: Why is litigation necessary?• The Result: FDA paralyzes the industry—manufacturers

cannot prepare PMTAs without knowing what is required• FDA only publishes “final” PMTA for ENDS Guidance on

June 11, 2019—one day before filing its remedy briefØ removes 8 of 29 HPHCs listed in 2016 Draft GuidanceØ add 11 new HPHCs

• On August 5, 2019, FDA proposes adding 2 additional HPHCs

Background: Why is litigation necessary?July 10, 2019: Acting Commissioner Sharpless states that FDA’s “policies and procedures [with respect to vapor products] are still evolving” July 15, 2019: Acting Commissioner Sharpless states that the Maryland federal court “recognized the agency’s work to provide a framework and clear guidance for companies” and that FDA has “outlined our recommendations for what the FDA expects to be included” in PMTAsFDA does not appeal Maryland federal court order and opposes industry motions to intervene for purposes of appeal

The Lawsuit

• Filed August 14, 2019, in the U.S. District Court for the Eastern District of Kentucky

• Names VTA and Vapor Stockroom, LLC as plaintiffs

• Asserts claims for violations of Administrative Procedure Act and Fifth Amendment Due Process Clause and seeks Preliminary Injunction

The Lawsuit

Relief Requested:Preliminary and permanent injunctions requiring FDA to:(a) establish a proposed and final rule governing PMTAs and product standards pursuant to APA’s mandatory notice-and-comment process;(b) set a reasonable, science-based, non-arbitrary deadline for the filing of PMTAs pursuant to finalized rule after notice and comment;(c) refrain from taking enforcement action against vapor products on market as of August 8, 2016, until new filing deadline

The Lawsuit

• 67-page Motion for Preliminary Injunction filed September 2, 2019; oral argument requested

• Briefing Schedule:Ø Government’s opposition / motion to dismiss due 10/11Ø Plaintiffs’ reply due 10/31Ø Government’s reply / motion to dismiss due 11/13

The Lawsuit• Preliminary Injunction Motion presents 10 reasons why

manufacturers cannot comply with May 11, 2020 deadline:

(1) only 5-6 aerosol testing labs with meaningful HPHC testing experience;(2) none of these aerosol testing labs have validated procedures for all new

HPHCs recommended by FDA;(3) only 6 or fewer clinical labs with expertise to handle PK and topography

studies recommended by FDA;(4) limits of detection for some HPHCs with existing lab equipment exceed

general population-level threshold levels of concern for some HPHCs;(5) no guidance document from FDA on desired HPHC testing methodology;

The Lawsuit• Preliminary Injunction Motion presents 10 reasons why

manufacturers cannot comply with May 11, 2020 deadline:(6) product stability and shelf life testing takes more than 12 months;(7) human clinical pharacokinetics and topography studies cannot be completed in

fewer than 12 months;(8) nationally representative behavioral studies cannot be completed in less than

10 months;(9) other open technical questions, including device settings, e-liquids for testing,

and “heavy” and “light” usage patterns;(10) 10 months is really 7 months; consulting firms require 3 months to organize

and collate data and studies to prepare PMTA for final submission by deadline

Questions?Eric N. Heyer, Esq.

Thompson Hine, LLP 1919 M Street, N.W., Suite 700Washington, D.C. 20036-1600

Office: 202.331.8800Email: Eric.Heyer@ThompsonHine.com

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