FDA and Clinical Trials



so what I'm going to do today is literally condense an entire course into an hour so consider yourselves forewarned and the other piece of it to know is it's going to be both very dense and very shallow and you can do both believe it or not so what I actually will ask is that if you have any questions please stop me because otherwise I'll be motoring to the next thing before you've even had time to process it so questions any time just raise up the hand or shout out I don't actually care I don't know how the Darden culture works with these things so what we're talking about today is the Food and Drug Administration there will be a few things on the outside coming in as we'll discuss and I always think it's a useful thing to start these talks with a view of who the stakeholders are so we have an idea of who's both influencing the system and who's being influenced by the system and in this area it is truly a give-and-take both ways obviously first the public both in terms of getting access to drug products and also protection from those drug products now interestingly the public has changed quite a bit in the last couple of years and through various interest groups become very active in this enterprise so you will have disease groups who actually Lobby FDA very strongly you will also have various consumer protection groups who lobby and petition FDA very strongly and they have considerable influence and I suppose one could also say within the public you have senators and members of Congress who are also loving FDA more directly because they control the funds then we have industry I've listed the primary lobbying groups here with industry so you have pharma which is the drug industry Advan ed devices and bio biotech industry obviously industry goes beyond just the lobbying organizations but they are the main spokesman a spokesman for industry then you have investors and investors are interested in every piece of this typically as I will discuss as we get through the phases of research and developing a product what you'll see is there are certain places where they have considerable interest not necessarily in the early stages but once there is a possibility that something may be approved that's when you will still start seeing a lot of action with investors and FDA has to be sensitive to this because they're very conscious of the fact that they are moving the market with their approval process and if you don't I think the best image to have in your minds of this is Martha Stewart that was involved with the drug Erbitux which was an in Clinton product then scientists both in and out of academia so I would actually say 30 years ago if I were talking about this I would be largely focusing on academia now more of the science is going on in industry and in fact in small units especially in the biotech industry physicians are both users and developers of these products and then finally the government and what a tangled web it is it is worth looking just at a map of HHS generally most of this is falling within HHS but it is not all there for example you will have the FTC having a very important role with advertising I'm not going to spend much time on that today because I couldn't get it all in but if you have questions about advertising and the one thing I would actually say since I'll leave advertising in a minute is to say that although people don't control in the sense of paying for drugs they are very important in terms of what they ask for and so you have the whole direct consumer advertising movement that has had a profound effect on this industry and it's also at the same time something I think many drug companies wish it they could put that genie back in the bottle and not do it it becomes an arms race and so you'll find a great deal of sensitivity to that issue as you go along so obviously FDA we also have the office of human research protection you have the Centers for Disease Control and the behemoth actually much more important than its obvious until you start getting into this is CMS Medicare Medicaid and the reason they're such an important player is because they control what will be given to a huge part of the population that's taking these products and so they will play a bigger and bigger role as we go on but already a very important role so this is FDA's mission statement and it's important to realize that FDA views itself essentially as a Public Health entity which people don't necessarily think of but it really does think of itself as both the gatekeeper the protector and also the developer and it's that tension actually and we'll talk about that just with some pictures at the end that is constantly at the forefront for FDA both the desire to produce products and quickly and the desire to protect the public from the dangerous products that might be produced now at this point we're going to go through the process of the development for health products I'm calling them because I'm about to make you stop thinking of drugs as an overarching category and I put as my subtitle here a long and expensive process the reality is we don't know actually how expensive it is the current figures you'll get from Pharma for example is a billion dollars billion dollars per approval but that includes a lot of opportunity at least half is opportunity costs they're counting all the drugs that don't get approved in that billion dollars the low end of the figures comes from orphan drug production where there isn't as much profit incentive and you can actually see drugs being approved for a couple million dollars which these days is very little so we don't know people are starting to try and figure this out but so much of this is protected by trade secret so much of this is protected by securities laws that it's very difficult to understand exactly how much this costs so the first question is what is a drug and drugs are not as clearly drugs as we think of certainly today let's say I am on loratadine which is Claridon in its generic form I have sudafed going today as well and those are classic drugs chemical formulations and in fact in my case interestingly enough all generics so they are no longer covered by patent I am taking and I'll describe briefly the generic process as we go along the interesting thing is a very broad definition if you look here intended to affect the structure or any function of the body so I gave you some examples of drugs you would think of as drugs but this may strike you as odd if I create a transgenic animal the gene construct that I insert in that animal as I am producing it through the cloning process is considered a new animal drug so not what any of you would normally think of as a drug but it is at least by FDA's authority not clear that the courts would accept this but fits the category of in all intended to affect the structure or function of the body now the next is is a vaccine a drug and the answer is vaccines aren't drugs vaccines are biologics in fact they're probably really the only clear category that is a biologic after that we start getting to FICCI things with this biologics tend to be related to immunogenicity but they may not be so that's one way you can try and categorize the reason these matter is both the process they're going to go through in approval and also their patent eligibility so for example biologics this is being negotiated right now in Congress will have a different patent path than drugs do the other important piece of biologics is right now you can't create a generic so that's also in the middle of debate so whether it's a drug or a biologic matters to you a great deal because it's future at profitability is going to matter on how it's classified from the very beginning now the next category is devices this would include band aids includes crutches these are all your classic early stage devices it includes a CT scanner it includes a stent that you'd use to hold a vessel open all the different things you can see up here it may also include an iTouch that a physician is using to look up drug information it may include the computers that and the software that is being used this is FDA is claiming that it does have jurisdiction over information technology and the health records and those are devices and that FDA should have jurisdiction over them I think they clearly fit as device whether FDA gets jurisdiction it's a whole different story but that's one of the big fights going on right now the interesting thing with the device definition is it's that there that we actually get information about the drug definition nowhere in the actual drug definition is there anything about chemical action but in devices we can carry that through and this statute was passed fourteen years after the drug statute so again it's not absolutely clear what's what now biologics actually are not even covered under the Food Drug and Cosmetic Act they're actually covered on a previous statute which was passed originally in 1902 the Public Health Service Act and actually come from it's a great little story that I can't tell the whole story about but what happened is they were deriving diphtheria antitoxin from a horse named Jim and unfortunately Jim also got tetanus and therefore as they were using this antitoxin they infected children with tetanus and they died and that was the original precursor really of all of these laws 1902 1906 is the first precursor of the Food Drug and Cosmetic Act as we know it so these give you the different centers that have authority for these drugs devices and biologics you'll notice I am pretty careful to say most there are exceptions within all of this and some of this is driven by expertise as well but this pathway actually matters as well because it's not just the law but also who the people who are involved in these centers are and the cultural history of those centers has a big impact on the pathway of the approval and as I showed you um two different statutes Food Drug and Cosmetic Act the Public Health Service Act the Public Health Service Act is about eight pages long the Food and Drug Act is about five hundred pages long so that does give you something it's interesting as a question of administrative law but I can't go through that right now so the approval process what does it involve first thing is what does approval mean and in most cases for biologics and drugs and I'm going to hesitate for a minute and many devices it means that it is both safe and effective until 1962 all a product had to be was safe it did not have to be effective but in 1962 this holiday er of effectiveness came in and an important question would be is what does effective mean and interestingly it means different things in drugs means different things in device devices it clearly means different things in terms of biologics there we use the word potency and but overall we're looking at a certain statistical significance of effectiveness and FDA has extensive guidelines on exactly what they will require to show that a drug is effective for approval what it means also is you can't market it all of FDA's authority here extends from the Commerce Clause so it's actually you cannot put this drug device or biologic into interstate commerce now if you followed any Commerce Clause law you would know that that is very broad designation things that never intend to cross state lines still affect Commerce we're actually going to be fighting about what the Commerce Clause means with healthcare reform but I when real scholars look at this I think you would see a very broad definition of Commerce Clause continuing and clearly for drugs now there one exception to this or actually the major exception to this to be clearer is for devices devices were not covered under the same rubric as drugs and still aren't until 1976 and that's actually Dalkon shield FDA is a story of scandal one scandal to another drives new let again the litigation in fact one of your goals in the next couple of years it's not to be the root of our next piece of regulation so in 1976 what happened was they realized that devices were potentially dangerous devices were not necessarily effective and they were being brought into the fold but we had many by that time many many devices already in the market and how would we shortcut this process and what was developed extremely legally creatively was this 510 K process and with the five take a 10 K process you can shortcut a very and we're about to go through the steps of an approval process but you can shortcut the approval process by showing that your new device is substantially equivalent to a device that's already on the market now in theory that was at least originally a device that was in the market in 1976 there is a piggybacking mechanism where you could actually have it be substantially equivalent to a device that was brought in the market last year that was substantially equivalent to a device that was brought in the market five years before that all the way back to 1976 what you end up with is devices that can be quite different but they do meet the criteria and I don't have time today but be aware that that substantially equivalents is going to be a very important piece that you would have to look at now when FDA clears a device subject to this it is not saying that this device is safe and effective all the clearance really means is it is as safe as an effective as the predicate device and that's an important piece and in fact the studies that you would use to prove that are very different than the studies that you would use for a drug approval now there is also another pathway for devices and that is roughly the exact same story that you would have with drugs and biologics a full approval process and if you get a PMA that device is safe and effective for its intended use so the very first stage of this is preclinical investigation this is classic bench science a lot of toxicology a lot of chemistry just in the case of drugs really looking at different molecules seeing what they do at this point the FDA's involvement is largely on the outside there are FDA rules on what good laboratory practices are but FDA is not going further than inspecting to make sure that those good laboratory processes are being followed if you are doing animal research you would be subject to the AIA cuck which is a review body in institutions that would review the ethics and methods that you would do with animal research and FDA has a role there the USDA has bigger role their FDA advice might be sought at any time here and in fact many companies that some of you may be working at will be doing that because they're actually trying to clear their pathway from the very beginning so they don't waste time as time is money now the step before you are allowed to do clinical research with humans is you must apply for an investigational new drug application you make an investigational new drug application and you get an IND as a result of that you have to obtain an IND for each new intended use and oddly enough perhaps to some of you you can obtain an IND on something you don't own and that does happen typically those are drugs devices that are already on the market and someone is looking to use them in a new fashion a typical IND contains 14,000 pages so while I made it sound like there is not a lot going on in that early stage this is still peanuts compared to what's going to come with the approval but 14,000 pages Andrew no off-label use by a physician would not require an IND but off-label research with large often require an IND so these 14,000 pages are submitted FDA has by regulation one month to respond to it and this if you know I can tell you absolutely three different tales of the FDA and if I want to scare you about believing that there's any real safety here this is one of the pieces I would tell 14,000 pages is a lot to digest I I can tell you this because I just read the 4,000 pages of the health care bills and that almost killed me so let's extrapolate that on and this is not done by a lot of individuals it's actually a fairly small group that has responsibility for this this is also a very important place where the center designation is made remember I told you there is the Center for biologics Center for device devices Center for drugs some of these products are going to be a mixture of the two so you'll have stents for example that are coated with a drug and the question then becomes well is it a drug or a device and it's at this point that you would actually make that choice I will tell you with hopefully not getting myself in trouble most people when given the choice go to devices not to drugs and their cost and also cultural issues involved in that choice they don't get to fully make the decision at the actual there's an office that deals with combination products now each clinical trial that you want to do has to be submitted to an institutional review board and what this idea of the institutional review boards how many of you have heard of institutional review boards how many of you have completely negative views see I didn't tell you I was on it before I asked that question and you know what IRB czar is really both the best and the worst of oversight there are all sorts of questions of whether I Arby's you know focus on the wrong things they're all tied and you know my case grammar issues right they you know I know words matter I try to hold that back and so what you'd actually find with this is they play a extremely important rule on safety but they also slow things down and they may get focused on things that don't matter and completely miss things that do matter I can tell you that I Arby's and let me actually back up before I do this and tell you exactly how they work each institution that is conducting research that does a lot of research would have what's called federal-wide assurance they'll have at least one IRB for that research if you want to do research in your institution or your with a small biotech hasn't yet set up its own IRB you can also get go to a private IRB or another institutions IRB for approval and so but you must go through an IRB what the IRB is looking at when it's doing this is both the ethics IES are the right people being involved are they do they have informed consent are they being put at too much risk what are the likely adverse events what are the benefits do the Bennets benefits at least equal the risks that's the major calculus that's going on the idea with them is that they're local so they know the players they know also the science it has to have a broad group of people both community members and scientists on it and it substitutes to some degree and overlaps in another degree for the work that the oversight groups in the government are doing but you will get IR B's first of all that are overworked they may take some of them five minutes on each protocol which is not a lot of review time or others are spending too long on things that are sort of nutty so there's a lot of change and flux going on in this area so the first study a first stage of drugs and I should tell you that all of this is going to be on a spectrum so when I talk about a phase one there also people will talk about phase one a phase one B phase 2a 2b and you could actually go through the middle of some of these but by giving you the basic structure you'll be able to see where these fall in this continuum so phase one is the initial administration of and I'm using a drug because it's easier in this context a drug to humans you use a relatively small number of humans 20 to 30 maybe even ten depending on what chemical entity you're talking about and typically those humans are supposed to be healthy volunteers because you're looking at safety at this point you're actually not looking at efficacy and one common misconception people have is thinking once it's gone through phase one that it's showing signs of efficacy that's only true if that phase one is actually a phase one B that's pushing on Phase two only safety now the exception to what I said about and incidentally there have been a few phase ones where there have been horrible deaths one occurring fairly recently in Britain also a number here in the last ten years where there were just things that no one predicted that happened often what these end up being our huge immune responses that no one is anticipating oops I'm getting ahead of myself the one difference with the healthy volunteers is and these are often the most profitable drugs are cancer drugs for example drugs that are too toxic to give to a healthy normal volunteer so you give them to the subject population there is a lot of push-pull on this data does show that most cancer patients who participate in phase one trials still believe that it will be helpful to them and I have a number of colleagues who have actually said what we should have in the consent on the front page is there is absolutely no way this will help you and you may die and that is actually the most accurate way to describe many of these phase 1 studies that's in the in the toxic drug realm so just safety now at phase one now we move to Phase two with phase two you have an expanded subject group we're still talking about a target conduct condition and there are a lot of games you can play at this point and I can actually tell you that I can I've been doing this for a long time now I can identify within five minutes whether a study is sponsored by for example a pharmaceutical company or pure science or government and you can see by the design what they're trying to achieve so they're looking within this design to prove safety still but also initial indices of effectiveness and for many of you in this room this is a crucial stage here because when we get past this stage is when a lot of publicity will start seeking additional investors things like that it actually will affect the stock price of a public company and so a crucial piece right here here unlike phase one healthy volunteers here we're actually looking at the condition and that is an important piece we're gonna get our first data but we're not looking necessarily for significant data and at the end of this stage we're going to get together with FDA whoever has responsibility for it and together in a negotiation design the phase three studies that are going to be crucial for the review and approval of this drug so it's all set up at this stage in Phase three we're dealing with very large numbers possibly thousands of people and there are plenty of people who would tell you that's not enough I'll talk about Vioxx in a sec but many people would say if IX and phase three had involved more people many of the issues that later developed would have been picked up others will tell you that no it actually was there and it wasn't picked up so there are different stories you'll hear with Vioxx here you'll often have multi sent yes generics are on a completely different pathway they're on what's called an abbreviated new drug pathway and what they actually can do is piggyback on a lot of the research that's been done by showing that there it's a different thing they're not actually showing their drug as safe and effective they're showing that it is identical or within the drug definition identical to a drug now biosimilars don't they're no generic biosimilars yet there will be that's probably pretty close now this is a very important piece to keep in mind and it actually is the root of a lot of confusion on certainly on the public side of this most of this data that is being generated throughout the approval process qualifies as a trade secret as a result FDA gets it but FDA also says we will not make it available to anyone and it actually does create issues because later physicians can use a drug for example that is for a different use than the reuse that has been approved but they can't go and find out whether there were adverse events for example that someone studied about that that will not be revealed to them in fact they will not even be able to know that it was looked at except with some exceptions that came in with the 2007 and literally we call this food so with the 2007 amendment and food uh FDA tried to essentially thread needle and achieve some middle road where at least summary information of what the studies were going on from phase two on would be available so you can get some information in summary form but by no means the real data that's still going to be completely protected by trade secret and so that's actually a huge piece of this and a lot of lawyers spend a lot of time working on these trade secret issues now within this is a debate on what the label is and the label is a lot more than you may think it is this little thing here is probably what you think is a label and a drug on the other hand maybe you've seen the insert how many of you have actually read the answers they go on then these are very as you could tell very heavily negotiated pieces actually every piece of them the reality sadly enough is that normal people don't read them but I have yet to actually meet a physician who actually reads they're true to know and for prescription drugs unlike aspirin now the interesting thing with aspirin there are now FDA's way of dealing with some of that confusion is to give people more information as a result you now have these and I'll talk about this in the context of risk mitigation but their favorite risk mitigation strategy is to give these consumer information things that I've never met anyone including me actually who's ever actually read the whole thing I've started and then I fall asleep and I move on in fairness to them they start with risks and benefits on those so there is a piece of that but one thing to be aware of is this looks like the label you think that patient insert is a label but a label is it also may include any information that is given in conjunction with that product and to the point that books that you display next to the product might be considered part of the label and again I don't have time to go through this but this is one way that FDA before it had full authority to in the approval process used to actually pull drugs off the market by saying they were misbranded mislabeled and saying things that weren't appropriate so if I say and that maybe has been a fully negotiated term with FDA before that advertising came out it's voluntary but everyone does and the flip side to Philips point is it also setting out the risks so the way you state those risks in these labels also affects your live potential liability for when things go wrong with this product and again we won't have time to spend a lot of time on that but it's it's great for lawyers but it's it's tough on drug companies so we've done all this and remember I told you 14,000 pages for the IND now we're talking about trucks you drive literally drive into the FDA with your trucks of documentation and if everything's been right this is the material that's in those trucks and that is going to constitute the documentation for your approval now I call this how to avoid Vioxx although everything I have looked on this shows it doesn't do anything to avoid Vioxx but it's still a work in process now I'm about to tell them what by accident so let's imagine I have terrible arthritis and this is the population given by ox typically by ox is a cox-2 inhibitor a painkiller essentially not a narcotic it's very important to understand there is a difference there has originally viewed far fewer side effects than other types of for example ibuprofen and huge large doses causes bleeding that'll make you think about it when you're pulling out over dosing yourself on ibuprofen and so looks like the miracle drug we can give it to people who have arthritis often the older population anyone with different pains people loved the drug it was a very it was one of the most successful drugs when it was approved Merck was the well it's still the owner of buy ox but it's pulled it off the market what happened is and people will disagree with this is that even in the Phase three there was some incident evidence that people who were taking by ox were having more cardiac events than you would expect that was in the Phase three it was such a great drug that it was a much bigger population after approval and after approval a lot of things started coming in with people with heart attacks cardiac events deaths and what happened was is it created a major liability problem for Merc Merc pulled it off the market and this is if you want to talk about pharmaceutical ethics a real question because there are clearly people who were benefiting from Vioxx did not fit the risk profile for these cardiac events and do no longer have that option of taking it there are similar cockatoos on the market but most people tell me they're not as good and this so this has been pulled but because it was such a it cost Merc billions of dollars to pull this off the market and because it was such a huge problem it caused FDA FDA has never recovered from Vioxx it used to be considered by the general public to be one of the most trusted government entities and it has lost that trust so it has developed risk evaluation and post market monitoring that allows it to start trying to find these effects that occur in drugs only after they've they're hitting a population big enough to start identifying and part of it is this risk evaluation strategy risk value mitigation step the difficulty with it as I told you one of their favorite and this is also industry gets to tell FDA what their plan is and FDA will negotiate back and forth it actually will take months but also what frequently happens it's again one of these large consumer booklets that people get as their main strategy there are a number of drugs old line drugs Opia opioids are now under a whole REM strategy program and this is expanding it is very expensive because what I didn't go through was in the that billion dollars I told you for approval most of its in this clinical trial phase so we extend the clinical trial phase post market we're extending those costs considerably and often they're much bigger studies with a lot of data collection involved it's a work in progress because I'm not seeing it actually have a great deal of effect yet now I'm gonna highlight just one piece here it's the third bullet down this is actually an interesting question if any of you were aware of a case last June Wyeth V Levine that was decided by the Supreme Court again I can't spend a lot of time with it but what it actually ended up with saying is that there was no preemption in this instance so they could not a drug company cannot rely on FDA's approval of the label to say that the label is accurate and use that as a protection against the label the tricky part for drug companies however is to change their labels they have to get approval from FDA so there is this back and forth the current view is now you change your label immediately and then enter into negotiations but it is a very difficult thing for the drug companies to see and it has extended their liability considerably this is also going to be something changing in the law over time one issue is pediatric use kids are not small adults most of our drugs were not tested in children so the last 10 years there's been a great deal of interest both in the government side and beyond that in terms of expanding the research on children with both existing drugs and drugs that are in the pipeline so that we understand how they work on children and as I'll show you in a minute that comes with patent extensions and interestingly enough a six-month patent extension is enough of a motivator for a big drug not a small drug but a big drug I mean big profitable drug and to really motivate it but if you have a drug with a smaller population typically the costs of the trials to do the pediatric research prohibits that and people forego the patent expansion that's just on the pediatric indication yet approval time after we brought the truck in is typically it is by regulation guidance a hundred eighty days after filing but I do not see drug companies actually fighting that but there when it goes past that there is a negotiation period within this and one thing that I'll just mentioned briefly some of this timeline is set by statute and regulation in return for drug companies paying user fees to FDA that pay for the approval process one thing you should be aware of is this creates an automatic conflict of interest you have the drug companies paying for the oversight people will argue over how much of a real conflict that may be so typical twenty year term remember you have to file at the moment this is a gleam in your eye that patent I mean you've had the patent discussion here so the moment you have a gleam in your eye you file it so in a case of a drug the moment that molecule looks like it's going to do X Y or Z you're filing your patent so you can easily eat up a 20-year patent period in much of this development phase and oversight and with certain drugs you'll have the clinical trial phases extend over seven years or so so in the 80s in return for getting a Perl politically allowing I don't mean they could allow or not the introduction of generic drugs the drug companies won in return for that patent extensions again they're a little bit complicated in figuring out exactly what they are but if you've had a very long review process suffice it to say you get some of that back on the other side but there are limits of it other types of patent extensions if after the phase three period you have FDA saying we want more clinical trials they'll get a patent extension and very important one for orphan drugs and devices for these are and actually biologics now get orphan status if you have a disease that affects fewer than 200,000 people there's very little incentive for a drug company to create a product to deal with that so what we've done is both shorten different pieces of that approval process but also give an extended patent protection so that they have more time to reap the profit from that product I mentioned generics they get an abbreviated new drug application process and as I mentioned the major function of this is to show that the drug is bio equivalent to the predicate drug so the drug that is approval is approved is about to have its patent expire you actually can start this process before the patent has actually expired there are all sorts of incentives in there to get you to do so since you've had some discussion yes no still not going to be released it's still considered entirely proprietary and it's an interesting question in this how they get to show that bioequivalence if you could use all that data it would be automatic but they're not allowed to they can use anything's public and their different pathways if it is public if there's enough material that's public there are different pathways for this approval they do have the patent yes well to make it yes they have the information you would need to make the product but they don't have enough information to show that it's safe and effective because that's all done in the clinical trial phase and that is all proprietary information yes yeah the specific term is bioequivalent because they're not actually showing that it is safe and effective they are showing that it is vile equivalent so what that bioequivalence would mean and in fact bioequivalence doesn't mean what the public thinks it means they think public generally thinks it means identical and it's not it actually could have a different formulation different route of delivery and different certainly different in active ingredients but it can even have different active ingredients if they function in the same way so they have access obviously to the entities themselves they're analyzing them and then they're showing that their bioequivalent but this is why you'll see people say that for example generic tylenol isn't the same it's not completely identical there are different AI that in actives in that case but it does shortcut considerably this process you can do an end a review within a year I'm running low on time so the last thing I wanted to do here is actually just since sometimes pictures speak more than words is show you through a series of cartoons and pictures the different tensions that are involved in this this is actually from the 1980s and this is where FDA first came under fire actually with the AIDS issues where it was viewed that FDA was overly concerned about protection and as a result people were dying because drugs weren't coming to market quickly enough and actually in response to this FDA has set up a fast-track process which gets you through approval more quickly the interesting thing with AIDS by fast-tracking AZT they actually ended up having a lot of problems because they didn't get the dosing rate before it was actually in the market and so people were starting to refuse AZT and dying so there are issues back and forth with this then consumer groups will tell you that FDA is in the pocket of industry and all they do is rubber stamp the whole process this is one of my favorites because I've tried doing the acronym game myself can you see it enough to FDA every five years ago every five years or so there is a huge conflict of interest scandal and in fact one of the commissioners had to resign because he didn't recognize his own conflicts of interest and this is the last one this is a wonderful ad it really captures them well this was an article excuse me in Business Week but it was an ad essentially from my point of view point of view they're trying to protect the public that has unrealistic expectations protection government blames them for everything that goes wrong so if they over regulate and then and then the advocates like their gay rights advocate say you don't allow enough drugs to be approved why can we get these in Europe and not so it's like they can't please everybody it's just an impossible job yeah I think we have unrealistic expectations that is it's like Vioxx nobody could really I don't think until I got into a lot more people that it was dangerous I think what we tend to do is we over react so work took it off the market because they didn't want to get sued but there was a student in the class last year who said he talked to his grandmother who said the saddest day in her life was when they took off the market when it meant for her the difference between being mobile and being able to do stuff yes and she said we don't make that value proposition we don't let people that captures very well you know that's exactly what my message at the end was yes not directly there actually is an approved product called Marinol it's I think off patent by now which is THC in a pill form people don't like it because it gives you a big hit you don't get the soft hit that you would get out of not speaking from experience you're not getting exactly so so it's not been popular in that community FDA obviously because it's an illegal product has no authority over the approval should it get to the point where it would actually have to go through an FDA process but we don't do it quite that way because it's a little complicated as it's an herbal so it could be treated under and FDA hates herbals so FDA would say it had to regulate it you'd have a whole sector of the population saying no we should just let it treat it essentially like an we treat dietary supplements through a different delivery factor it's going to get even more complicated because of the tobacco bill that was passed and there are all sorts of questions of how delivery effects whether it's treated as a drug or not but to make cigarettes now obviously it is now since last year oh yeah the tobacco bills passed last year so FDA well they don't they have oh that is exactly why people said they should not be allowed to regulate because it's the only product FDA regulates that is actually dangerous with the risk-benefit process they are providing very specific regulation under the statute and it governs things like advertising it governs composition addition of nicotine things like that but interestingly there has anyone seen these C cigarettes e-cigarettes I think almost all of them are produced in China and what they are is a little device pure nicotine and you can get except they're marketed for recreational use and you can use them and you get a hit of nicotine FDA tried to regulate them and it got hit based on this suit that Kessler did it's it's at the district court level now but what they actually said was no you got that wrong and with Kessler and you got it wrong now we're not going to consider them something that's a nicotine delivery device I think yeah it is a nicotine delivery device so it's an interesting case that's moving through the courts right now do not assume logic that's an important piece to any other questions I'm over time so

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