VT VTA v A v. FD . FDA A Li Litigation Up Update ERIC N. HEYER THOMPSON HINE LLP
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Ba Backg kground: Why y is s litigation necessa ssary? y? 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 May 5, 2016: Draft Guidance on PMTAs for ENDS published.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.
Ba Backg kground: Why y is s litigation necessa ssary? y? 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.
Ba Backg kground: Why y is s litigation necessa ssary? y? March 27, 2008: Maryland federal court lawsuit filed against FDA Ø Plaintiffs include American Academy of Pediatrics, Campaign for Tobacco Free Kids, American Lung Association, American Heart Association Ø Complaint seeks ruling that extension of PMTA compliance deadline was ultra vires and contrary to Administrative Procedure Act Ø Plaintiffs seek to remove all vapor products from market
Ba Backg kground: Why y is s litigation necessa ssary? y? July – August 2018: cross-motions for summary judgment filed March 26, 2019: Maryland federal court denies Plaintiffs’ motion for summary judgment without prejudice April 2, 2019: Plaintiffs file motion for reconsideration
Ba Backg kground: Why y is s litigation necessa ssary? y? May 15, 2019: Maryland federal court grants Plaintiffs’ summary judgment motion Ø declares FDA acted unlawfully in extending PMTA deadline to August 2022 ( ultra vires and lack of notice and comments under APA) Ø invites supplemental briefing on appropriate remedy
Ba Backg kground: Why y is s litigation necessa ssary? y? June 12, 2019: FDA files remedy brief Ø argues Court must remand issue back to agency Ø 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
Ba Backg kground: Why y is s litigation necessa ssary? y? 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.)
Ba Backg kground: Why y is s litigation necessa ssary? y? 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.
Ba Backg kground: Why y is s litigation necessa ssary? y? 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 brief Ø removes 8 of 29 HPHCs listed in 2016 Draft Guidance Ø add 11 new HPHCs On August 5, 2019, FDA proposes adding 2 additional • HPHCs
Ba Backg kground: Why y is s litigation necessa ssary? y? 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 PMTAs FDA does not appeal Maryland federal court order and opposes industry motions to intervene for purposes of appeal
Th The Lawsu suit 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
Th The Lawsu suit 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
Th The Lawsu suit 67-page Motion for Preliminary Injunction filed September • 2, 2019; oral argument requested Briefing Schedule: • Ø Government’s opposition / motion to dismiss due 10/11 Ø Plaintiffs’ reply due 10/31 Ø Government’s reply / motion to dismiss due 11/13
Th The Lawsu suit 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;
Th The Lawsu suit 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
Ques Questio ions? ns? Er Eric N. N. Heyer, Esq. Th Thompson Hine, LLP 1919 1919 M Street, N.W., Suit ite 700 700 Wa Washington, D.C. 20036-1600 1600 Office Of ce: : 202.331.8800 Ema Email: Er Eric.He Heyer er@Tho homp mpsonHi nHine. ne.com Vi Visit o our w website a at w www.ThompsonHine.com
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