"The backlash to a derided process, on which millions of former smokers depend, is only growing."
The FDA missed its deadline to make decisions on the biggest vape companies’ products; it has subsequently approved just one. The agency has meanwhile issued marketing denial orders (MDOs) to numerous smaller players—and many of them are now pushing back against a process that has caused widespread anger.
Court documents paint the PMTA process as even more chaotic and unfair than critics have long maintained.
MVO initially filed a petition for review in the Ninth Circuit Court of Appeals at the end of September, as dozens of other vapor companies have done. Most have argued, in part, that the FDA’s denials were “arbitrary and capricious,” and that, in rushing to meet a court-imposed deadline, the agency overlooked vital information. Many manufacturers, too, have repeatedly complained of the FDA shifting its goal posts—and offering guidance on certain studies only after PMTAs had been filed.
As a result, MVO, like many other smaller companies, sits on the brink of financial collapse. “This financial harm is unrecoverable, as FDA, as a federal government agency, enjoys sovereign immunity,” MVO’s lawyers write.
Now, MVO’s attorneys are demanding that the appeals court grant a judicial stay for the company’s denied products by the end of October. In court documents reviewed by Filter, they paint the PMTA process as even more chaotic and unfair than critics have long maintained....."
"The backlash to a derided process, on which millions of former smokers depend, is only growing."
“FDA’s about-face from its prior representations violates fundamental principles of administrative law,” the document continues."
See whole article here:
Backlash Against the FDA Grows as Vape Company Ramps Up Legal Fight
The FDA missed its deadline to make decisions on the biggest vape companies’ products; it has subsequently approved just one. The agency has meanwhile issued marketing denial orders (MDOs) to numerous smaller players—and many of them are now pushing back against a process that has caused widespread anger.
Court documents paint the PMTA process as even more chaotic and unfair than critics have long maintained.
MVO initially filed a petition for review in the Ninth Circuit Court of Appeals at the end of September, as dozens of other vapor companies have done. Most have argued, in part, that the FDA’s denials were “arbitrary and capricious,” and that, in rushing to meet a court-imposed deadline, the agency overlooked vital information. Many manufacturers, too, have repeatedly complained of the FDA shifting its goal posts—and offering guidance on certain studies only after PMTAs had been filed.
As a result, MVO, like many other smaller companies, sits on the brink of financial collapse. “This financial harm is unrecoverable, as FDA, as a federal government agency, enjoys sovereign immunity,” MVO’s lawyers write.
Now, MVO’s attorneys are demanding that the appeals court grant a judicial stay for the company’s denied products by the end of October. In court documents reviewed by Filter, they paint the PMTA process as even more chaotic and unfair than critics have long maintained....."
"The backlash to a derided process, on which millions of former smokers depend, is only growing."
“FDA’s about-face from its prior representations violates fundamental principles of administrative law,” the document continues."
See whole article here:
Backlash Against the FDA Grows as Vape Company Ramps Up Legal Fight
