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US FDA up against the ropes in fallout from PMTA denials and legal challenges

Uncertainty is mounting over the US Food and Drug Administration (FDA)’s premarket tobacco application (PMTA) process after the agency shifted its position on Juul Labs’ application, leading to questions about the inner workings of the agency as it faces ongoing legal challenges.

Eric Lindblom, a senior scholar at Georgetown University Law Center’s O’Neill Institute for National and Global Health Law, told ECigIntelligence: “Going forward, what the FDA ends up doing with Juul will tell us a lot – as would the FDA just sitting on it and doing nothing for weeks or months.”

Lindblom called the FDA’s initial 23rd June decision on Juul – when it ordered the company’s products off the market – “odd”, further labelling its 6th July reversal “baffling”. He questioned what kind of legal advice the FDA and its Center for Tobacco Products (CTP) was getting.

“How did the lawyers let the FDA/CTP go forward with that decision if it was so weak that they quickly backtracked when, predictably, Juul and Altria challenged the order in court?” he asked.


Questioning the FDA’s thoroughness


Bryan Haynes, a partner at the law firm Troutman Pepper Hamilton Sanders, said some industry insiders are particularly concerned that FDA reviewers “are not necessarily thoroughly reviewing these applicants”.

“Some companies that have received marketing denial orders have reached out to the FDA to say, ‘Hey, actually, we did have studies that you say we did not have’,” Haynes told ECigIntelligence.

“That’s obviously disappointing from an applicant’s standpoint because an extraordinary amount of time, money and effort goes into these submissions. The FDA has taken a very long time to review these submissions. It’s surprising that FDA would overlook, for example, studies evaluating the effect of these products on human health.”

Haynes is not wholly unsupportive of the job regulatory agencies have to do. He said he does believe there should be room for them to adjust their decisions as new information comes to light. He said agencies such as the FDA need to be allowed “to take a hard look at their decision-making process” and adjust their decisions as they see fit; but the reversals on PMTA denials are concerning because the FDA is “evidently overlooking a lot of things in a lot of cases”.

“It seems like they’re overlooking things that really should not be being missed,” Haynes added.


FDA argues its defence, but is it enough?


The FDA has defended its PMTA review process in various court proceedings, with differing results.

FDA lawyers said in an oral argument on 17th May that the agency does have consistent policies, and that companies with failed PMTAs tried to pass off literature reviews as scientific studies, including some submissions that offered mixed conclusions about the benefits of vaping versus the harm.

But the lawyers did not address the fact the agency has reversed course several times, and Lindblom said the sudden retreat on Juul indicates struggles that he believes are also happening within the FDA regarding how to handle menthol-based e-cigarettes “knowing it will be legally challenged in court whether it allows any menthol e-cigs or not”.

“But the FDA could avoid all these problems and have a clear path forward if it simply took the purposes of the Tobacco Control Act (TCA) and the PMTA process seriously and began working directly and effectively to protect the public health and prevent youth use,” Lindblom added. “It has not yet done that with any of its PMTA decisions for e-cigs or, earlier, other products”, such as snus or Iqos.

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    In Juul’s case, the company filed a legal challenge in the US Court of Appeals for the Columbia Circuit in Washington DC, seeking an emergency stay amid the court’s broader review of its request for a permanent injunction. The court granted it, and the FDA rescinded Juul’s marketing denial order (MDO) before the broader legal challenge was addressed.


    ‘Hell-bent on rigging the process’


    Amanda Wheeler, president of American Vapor Manufacturers, said after the FDA’s initial denial of Juul’s PMTAs that the decision “shows that the agency is hell-bent on rigging the process to fulfil its prohibitionist agenda”.

    “Their analysis seems completely arbitrary, and no amount of data or evidence will sway the FDA off its destructive path,” Wheeler said. “Without a major course correction, the FDA will regulate adults back to cigarettes.”

    Juul said the agency overlooked a mountain of data when it issued the MDOs, which Wheeler’s group cited when calling for an investigation from the office of inspector general for the US Department of Health and Human Services into “improper political pressure that appears to have influenced senior leadership” at the FDA, and how that influence “has corrupted FDA’s statutory obligation” on PMTAs.

    Wheeler’s letter referenced comments made by Dick Durbin, the Democratic US senator from Illinois, calling on new FDA commissioner Robert Califf to “do his job to protect our children or step aside”.

    Durbin issued the resignation call in a 22nd June press release that said: “For years, the FDA failed to regulate e-cigarettes, and allowed millions of vaping products to illegally enter the market, fuelling the youth vaping epidemic.”

    News broke later that day about the FDA’s plans to reject Juul’s PMTAs.


    Calls for investigations and transparency


    Wheeler said: “Without a transparent accounting of how these decisions were made, we are forced to speculate that political pressure, not science or facts, has driven FDA’s conclusions.”

    The letter calls for the inspector general’s office to determine whether Califf knew the FDA’s initial Juul decision “was based on incomplete information” and to make public correspondence between Califf and members of Congress, as well as with the Wall Street Journal reporter who broke the story that the FDA would be rejecting Juul’s PMTAs.

    “Our businesses help adults access the most effective smoking cessation device ever devised,” Wheeler wrote. “Yet the FDA – the very government agency charged with promoting pubic heath – is actively undermining our efforts to end the cancerous scourge of combustible cigarettes.”

    Haynes said pending court challenges from companies seeking reversal of their MDOs will be very impactful when they are decided. “The folks that are challenging these actions in court have a very strong position,” Haynes said. “Stay tuned as these cases unfold.”

    – Meghann Cuniff ECigIntelligence US legal correspondent

    Photo: US FDA

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    This article was written by one of ECigIntelligence’s international correspondents. We currently employ more than 40 reporters around the world to cover individual vaping markets. For a full list, please see our Who We Are page.

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