NGO vs. FDA | Inside the Legal Battle that Could SHUT DOWN Vaping

NGO vs. FDA | Inside the Legal Battle that Could SHUT DOWN Vaping

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hi I'm Brent Stafford and this is red watch my regulator watch calm it's a mortal threat to the u.s. vaping industry that's how red watch characterized a lawsuit brought by a coalition of public health NGOs against the US Food and Drug Administration filed in federal district court of Maryland in March of 2018 essentially over the past year vaping has been on trial with the so called epidemic of teen vaping providing key evidence the verdict is now in and it's not good news for vaping the lawsuit was filed by the American Academy of Pediatrics American Cancer Society American Heart Association American Lung Association campaign for tobacco-free kids and truth initiative the suit challenged FDA's authority to extend certain compliance deadlines requiring eliquid and vaping device manufacturers to submit onerous pre-market tobacco applications or PM tas for each and every product that is currently sold on the market industry insiders estimate the cost of submitting a successful pmta could be as high as 1 million dollars per product and for those without they will be pulled from Michelle's joining us today to talk through the court case legal ruling and some of the other developments is a zine Chowdhury Azim is a regulatory and public policy lawyer with a focus on food and drug law and for the past nine years he's been one of the most prominent legal advocates for the vaping industry Azim thanks for coming back on reg watch thanks for having me so let's not bury the lead any more than I already have the FDA lost in the court case so why is a ruling where the FDA loses also a loss for vaping well in this case they lost on their ability according to the judge to change the pmta compliance policy deadline which they extended to 20 22 and that deadline was actually very important for the industry wasn't it right because as most people probably know when the deeming rule was published back in 2016 it said in an initial two-year compliance policy dead like that gave everyone on the market at that time until August 2018 to submit their applications for premarket review now we argued and as many people did that that was not enough time for the industry to put together these very complicated very intricate applications a lot of scientific details required clinical studies long-term data and so the FDA came out in 2017 and and extended that deadline to 2022 to give both industry and the agency time to sort of figure out what was going to be involved and so the public health nonprofit groups that are obviously you know entrenched in terms of their opposition to vaping filed this suit to say essentially that the FDA didn't have the authority to extend their own deadline right their position was that FDA did not go through the proper notice and comment rulemaking procedures when they decided to buy guidance document extend the deadline to 2022 so you know their position is that the the the deeming rule handled that and based on the comments that were submitted during the deeming rule FDA established a 20-18 deadline and and the agency couldn't just undo that on its own enforcement discretion without going through another rulemaking so to set this in terms of timeline for our viewers in January to February of 2018 is when the initial kind of media scare headline started coming out on Jul quite purposefully if you ask me and I think we've proved that and of course our collusion story that we did with Michelle Minton from Competitive Enterprise Institute earlier this year demonstrated that to a tee and so it was only just a month or so later that they filed a lawsuit and then we spoke in August it seemed that at that point that the FDA might have this whole thing handled you're right so you know 2018 was a big year in terms of for the vaping industry with the announcement of the the epidemic and the increase in underaged use what FDA initiated its youth tobacco prevention program they started coming after more companies with warning letters and on top of that sort of separately the NGOs here filed their lawsuit challenging FDA's ability to move the deadline and as they made clear in their in their documents and their briefs part of their argument was that you know had FDA not changed the deadline to 2022 then companies including Jul and everyone else would have had to submit their PM tas by august 2018 and maybe we would they would have prevented the epidemic again that's part of their part of their thought process I think into filing this lawsuit so walk us through exactly what the plaintiffs asked for and how did they persuade the judge to come along their way FDA's position was that this was within their enforcement discretion that it's a normal course of their authority to change deadlines as they see fit based on their capabilities and based on the science as necessary but the plaintiffs here effectively argued that this was the type of thing that the deeming rule and the Tobacco Control Act contemplated would go through rulemaking and as part of the Administrative Procedures Act which is sort of the overarching law here with anything administrative FDA was bound to go by its notice and comment rulemaking procedures before changing it deadlines such as this and that's what the judge agreed with at the end does that mean then every time FDA wants to move a deadline because they feel that because we know FDA even didn't have enough time within that two-year period in order to get their internal documents done because the guidance we know and we'll get to this a little bit more in a bit but the final guidance just came out last week so it's not like FDA had enough time to properly do their job either by August 2018 so they're supposed to do rulemaking just to change their deadline yeah that's a very good point and I think that's part of why this is indeed a very strange outcome and a decision from the court because this is the kind of thing where most judges would not you know weigh in on an area where the FDA in this case or the agency is the expert in that is normally within their course of business that they are able to decide when the best time is for both themselves and Industry and the public health to establish compliance policy deadlines so this is a rare type of decision where we see the court come out a different way have we ever seen anything like this where a third party is sought you know basically an injunction from the court to stop a regulatory process and and to basically control how a regular regulator like the FDA does goes of other business yeah I mean again it's rare I can't say for certain if you know we've seen anything because actually like this happened before I you know their position is based on the FDA not complying with their obligations under the Tobacco Control Act which effectively created an entire new new product regulatory scheme that requires pre market authorization for anything not grandfather and so their position is that everyone's products that are on the market that's not a grandfathered product that doesn't have pre market authorization is a unauthorized product and you know the deeming rule extended that compliance policy for a couple of years and considering the nature of tobacco products you know FDA shouldn't have done anything more than that was the plaintiffs position done basically that all the products on the market need to get pulled off the market immediately you know in their initial briefings then that is but the position they were taking that enforcement immediately is is what would be required if products were not subject to pre market authorization as I'm sure we'll get into there has been some additional documents filed per the courts request once he came out once the judge actually vacated the document and the plaintiffs are now asking for a relatively short time 120 days for companies to submit pre market applications so the plaintiffs are pressing for a hundred and twenty days dive into that a little bit more for us to understand that better yeah it's an odd sort of position because what the plaintiffs initially requested was that the guidance document be remanded back to FDA for FDA to come up with a new rulemaking or new guidance within the established law within their legal authority and now in this proposed remedy even though our interpretation of what judge was looking for was more of a timeline suggestion from the parties about what another you know rulemaking would look like in terms of how long that would take etc what the plaintiffs came back with instead was completely avoiding another rule making and any you know accepting any other comments from industry or anyone else rather they came back with this 120 day four month deadline from the date of the ruling for all P mta's to be submitted that's simply not a feasible how come it will result in the entire industry being unauthorized and potentially y'all you pulled off the market and so it's really untenable and and it's again it's we don't think it's what the judge was even looking for in terms of a response from been but that's what you got so speaking of the judge yeah I'd like to read for you the first sentences in judge Paul Grimm's verdict which we have have up on the screen here for our viewers judge Grimm right it was bound to happen just as email and text messages replaced snail mail social media made face-to-face communications passe and the Internet rendered libraries all but obsolete it was only a matter of time before electronic cigarettes replaced combustible tobacco products as a desirable means of nicotine delivery as it turns out even at diction has become electronic and not only among adults but particularly for teenagers and younger kids especially as manufacturers of e-cigarette products have learned if they are fruit or dessert flavored and marketed as cool and alluring Azim this language kind of shows that they really bought into the story that the public health NGOs were pushing yeah absolutely I mean you could have read that statement to me directly off of the campaign for tobacco-free children's website because yeah it seems like at the end of the day the judge really bought into this argument that you know it's the main purpose of these products is to addicted to a lifetime of nicotine addiction and potentially tobacco and you know we really think it's important for the judge to consider in addition the arguments made both by the amicus filers and the FDA actually you know mentioned in their remedy brief a few times that there is an adult population here that is relying on these products to reduce their harm and to to in some in many cases quitting smoking and that simply cannot be ignored so was it a mistake for industry not to try to intervene in the lawsuit right off the start well you know in hindsight it just would have been a lot easier had industry intervened well the industry didn't intervene initially what has happened since the verdict or since the judge's decision was a number of industry groups and stakeholders attempted to to file motions to intervene on the issue of the remedy which again is this idea that because we're in a post 2018 world and technically now all applications were due in 2018 the judges asked the parties to brief on a solution what what do the parties believe can be done down to two account for this situation a number of companies duel and enjoy the vapor industry and number of vapor associations represented by Keller and Ekman and some cigar company that we have the cigar industry attempted to file motions to intervene just to make sure everyone understands if you're granted intervener status then you're actually a party then to the suit so you've got more you've got a voice right exactly so as opposed to some an amicus frailer a filer excuse me intervening in a case assuming it's you know it's accepted causes the interview to become an actual party to the litigation so along with the public health groups in fda intervenors would have rights for example to appeal and so that's what an intervener is and what what happened was the industry attempted to intervene on the issue of what is the appropriate remedy and i think you're probably asked me about what happened what happened was the judge kind of decided up front that he wasn't going to permit any of these parties to intervene he pretty much slapped it down he he said that considering there wasn't an attempt to intervene at the beginning he kind of framed it now is that not better late than never with his judge basically and then he said that the government you were fine letting the government represent the industry's interests throughout to trial so you should be find out let the government represent your interests in the post verdict and remedies and so forth right so you know obviously i don't agree with that decision i think it's there's a lot of issues with that i mean the fact that the judge in this case decided to deny the motions to intervene before the actual emotions were even filed you know it's a bit of a I've never seen something like that happened before by the way what the judge did in that matter order was while he denied our ability to intervene in the case that's parties he said you can go ahead and submit you know a single amicus brief between all of you so all the companies I just mentioned both industries cigar and vapor would have the opportunity to spend one fifteen page brief which we did in lieu of you know actually intervening so hopefully the judge will review the the the amicus brief and the many declarations that were submitted in support of those brief from you know those stakeholders from those companies because what those declarations lay out very clearly is what this all really means you know what does a PMT a require why does it take so long how has the fact that FDA has provided only draft guidance up until this week played a role in in in the reason why companies have been reluctant to to begin you know to to start filing applications hopefully a judge will review those carefully review FDA's brief as well although we can talk about what they suggested now's a good very good time to do that what exactly did FDA submit it was on June 12th was the deadline correct they did so there their brief was due the same day as our amicus brief and you know the FDA also makes the argument that the judge here only has the authority to remand the guidance document back to FDA for further consideration not dictate a timeline for p.m. tas or anything else so they do make that argument and there are the number of good statements in there there's a declaration from center for tobacco products director Mitch seller for he states very clearly that the 120 days would potentially do a lot of harm to public health because it would force a mass exit of of most products that many adults smokers rely on to stay away from cigarettes so while they made that argument on the one hand they also in the alternative suggested that if the judge were to proceed with a time line rather than 120 days fda suggested a 10 month period to submit applications so you know so let's make sure our viewers got this right FDA said 10 months they'd be okay with 10 months in FDA's position in the position of directors LR while they would prefer not to have an accelerated timeframe to review applications they suggest that rather than four months with what the plaintiff suggested 10 months would be a bit better it would allow more companies to submit more complete applications particularly in light of the new guidance that came out which provides a bit more clarity I guess so while not ideal and they admit they would prefer to have longer they still put out sort of this 10 months sort of offer to the court in lieu of the you know plaintiffs offer which is 120 days so that I'm a bit astonished by that if FDA suggests 10 months why wouldn't the judges take 10 months yeah it remains to be seen again I don't know what the judge will do hopefully he'll take a good hard look at the the affidavits that were filed which again make very clear that you simply cannot even with the new guidance document 10 months is not going to be enough time to to gather the data do the analytical reports begin potential clinical trials which will take much longer to complete than 10 runs so FDA is basically saying we can't do it in four months if you aren't going to remand it back to us the shortest amount of time that we could do it is in 10 months I think the concern for our viewers when they hear that is if the FDA is offering that as a remedy to a judge that clearly seems you know obviously not really disposed to you know be very Pro vaping that really in the end we could literally be seeing PTM a deadline ten months from now ya know that's a huge risk there yeah that's that's a possibility that the judge will you know look at that as a potential settlement offer so to speak now again it's still possible that all of this could be appealed and the hope is that despite the fact that FDA has submitted a remedy here in pursuant to the judges request that they're still they're not precluded from actually appealing the original decision both on procedural issues such as whether or not the plaintiffs have standing to sue which wasn't part of the remedy discussion here but also just in general they're there their decision to vacate the judges document in its entirety so the FDA is not precluded from actually appealing this case to the Fourth Circuit you know to the appellate court for further review is that likely to happen or would FDA not just accept this as a punt and and a good you know it's not be basically the judge can take on a lot of you know the responsibility here for you know messing up the industry an FDA kind of got can punt this you know yeah but keep in mind you know I think from empty's point of view and one reason why they may appeal and again we hope that they do is because you know this could impact how FDA what if they can do an other you know other regulated areas aside from tobacco you know drugs and devices you know that this decision hinders their ability to establish compliance deadlines or enforcement you know hinders their enforcement discretion in other areas that's another reason why FDA may say wait a minute you know we want we want to appeal this decision so you may you know it's not just about vaping and kids here it could be a broader implications so can the industry do anything now at this point considering the fact that the judge is refused to allow you to turn to the process as an interview you've submitted amicus brief which you know judge is gonna look at go great and get on get on with you know destroying the industry and so is there anything else that the industry can do well you know again it's it's it's I'm limited in to what we can discuss here because this is pending litigation you know I will say that you know we're looking at options for the industry to appeal we are you know again the fact of the judge did I the interventions without giving even the opportunity to make those arguments I think it's something that we would consider looking at whether or not that could be appealed and but again hopefully the judge will will take a good hard look at those declarations and and understand that this is a really big deal it's going to impact a lot of people and and you know he can't possibly understand you know the public health consequences of these actions the industry is in the same position as it's always been over the last couple of years now we've got final guidance Oh but to even talk about what the guidance requires seems a little bit moot because we still don't even know is it four months is it is it ten months is it two years right so well you know that that's a good point you mean but that being said you know what I reckon my clients do is is look closely at the crisis document and start to process I mean this you know this the pmta process is not going to disappear you know what we hoping that the courts and the FDA recognize for paper products you know where they follow the continuum of risk that they give companies adequate time that they you know as they did mention a few places in their guidance document that there there could be other evidence that could be submitted in lieu of the most expensive and long term clinical trials to meet the pmta standard so I guess the bottom line is if you're a company you know do what you can to help with the advocacy efforts and the lawsuits but you also need to look at what you can do and in terms of getting PMT a process started because that is something that is going to one way or shape or the other it's going to come and you're going to have to deal with it


  1. This is getting completely stupid. Everyone knows the FDA doesn't have the means to manage or police the poorly thought out and implemented deeming rule. This, even after after it became clear that the deeming rule was an overreach and would cause a great deal of harm.

     All the FDA has to do is go limp on policing, however our concern now with the resignation of Scott Gottlieb is that we really don't know what the FDA is going to do. Not that Scott Gottlieb, a former part owner in a vapour business was any friend to vapour. It seems the position of "director" of the FDA forces that individual to (mostly) further the ends of establishment interests which means the interests of the "progressive" non-profits and pharmaceutical companies in this case. This lack of autonomy of the FDA should be of great concern to Americans, except they seem to just accept any stupidity in this with very little protest.

    Shame, USA. You've forgotten what you stood for in the first place. "A person (or country) often meets his destiny on the road he took to avoid it. (Jean de La Fontaine ~1661). In this case 'murica is running down that path at full speed. The nation that was the poster boy for civil liberties and freedom now has the most fascist policies on the planet, policies that have replaced public health with sycophantic ideology.

    I'm sorry but I'm completely disgusted by this turn of events. Another symptom of the decline of a former great civilisation. Stupid.

  2. Vaping helped me stop smoking!
    It will just go underground, then let the FDA (Fuc ing Dumb Asses) try and stop it!
    There is always have a loop hole.

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