Just got this e-mail from the Vapor Technology Association.
Now we wait for judge Grimms decision:
AAP v. FDA Update and PMTA Final Guidance
June 13, 2019
As we
reported on May 16th, 2019, the U.S. District Court for the District of Maryland issued a
54-page decision in American Academy of Physicians, et al. v. FDA, et al., Case No. 18-CV-00883. In its
order finding in favor of the plaintiffs, the Court vacated FDA’s August 2017 PMTA Guidance in which the Agency extended the deadline for the filing of PMTAs to August 2022.
Because the original deadline for PMTA filing had passed, the Court ordered the parties to submit additional briefing on an appropriate remedy. Specifically, plaintiffs had to submit their request within 14 days; FDA had an additional 14 days to respond to plaintiff’s submission; and then the plaintiffs had five days to reply.
In their submission, the plaintiffs asked the Court to order all PMTA applications to be filed within 120 days. Yesterday, FDA filed its response asserting:
- The Court should not go beyond vacating the August 2017 guidance and should instead remand the issue back to FDA to determine the appropriate course of action;
- Plaintiffs’ proposed 120-day deadline for the submission of premarket applications could adversely affect the public health and would be administratively infeasible; and
- The Court should not order FDA to enforce the premarket review provision—a step that would raise significant separation of powers concerns.
As part of its rationale, FDA argued, “First and foremost, from the public health perspective, a 120-day deadline would likely lead to a mass market exit of ENDS products.” FDA continues, “Indeed, it is the FDA’s ‘firm belief’ that such an accelerated deadline would ‘create a genuine risk of migration from a potentially less harmful ENDS products back to combustible tobacco products within the population of addicted adult smokers who have completely switched to ENDS. This is a public health outcome that should be avoided if at all possible…” In this context, FDA also noted that, “should the Court order premarket applications to be submitted by a date certain—and it should not …. — under no circumstances should it set that deadline sooner than 10
months from the date of its decision (with a one-year period for FDA review, without limiting the agency’s discretion to take enforcement action in the meantime).”
This latter statement needs to be understood in this context and not as the headlines have suggested.
What’s Next? In five days, plaintiffs will file their reply to FDA’s position. Then, the Court will take the matter under advisement. We anticipate that the Court will enter its Final Order no earlier than mid- to late July of this year. At that time, FDA will have 30 days to file its Notice of Appeal to the 4th Circuit Court of Appeals.
Given what is at stake, we believe it is highly likely FDA will appeal this decision to the 4th Circuit and also seek a stay during the pendency of the appeal.
Significantly, on June 11th, 2019, FDA issued its
Final PMTA Guidance. The Final Guidance included among other things changes to the HPHC testing requirements. The process outlined remains sophisticated and prohibitively expensive, and it will be extremely difficult for small businesses to satisfy FDA’s requirements. VTA is committed to continue to work collaboratively with regulators to find a reasonable pathway forward for our industry.
Sincerely,
VTA
