FDA Regulatory Authority



all right so the first agency that we're going to explore in our review of Pharmacy law is going to be the Food and Drug Administration now as the practice of pharmacy goes the Food and Drug Administration probably won't be in your life as much as you think it will be but it does have some bearing as to how things get done in terms of drug control and that's what FDA really is going to focus on when it comes to the practice of pharmacy just a little bit of history so from our last lesson we learned about the 1906 Pure Food and Drug Act this actually created what was called the Bureau of chemistry up until the FDA actually really gets going in 1938 drugs are not required to be safe so clinical trials not our requirement what was required was that drugs had to be listed in the United States pharmacopoeia or the National formulary we abbreviate those US P and F and if you see those at the end of the drug name that's exactly what they're referring to the label must contain the drug name its purity and be of good quality and drugs must be free of adulteration which means they have to be stored properly they must be in the same storage requirements that are listed in the USP or and F labeling certain drugs were barred from interstate commerce for a short time and that was later reversed by the Supreme Court the main act that really creates the FDA that we know it today is gonna be the Food and Drug Cosmetic Act of 1938 the FDA was actually created in 1930 after a couple of different little reorganizations that the FDA and C Act of 1938 has had several revisions but it actually now requires originally I'm sorry acquired that drug manufacturers proved their formulations were safe for use this was all a reaction to the sulfanilamide elixir disaster so let's talk about safe and effective all drugs carry side effects and risks yes you can actually kill a patient with sterile water you pump enough of it in there at one time you will eventually drown your patient through an IV so yes you can kill a patient with just sterile water safe really means that the benefits of the drug outweigh the risks the drugs possess so if death is a side effect then death needs to be very minimized event and that the drug really provides a substantial benefit safe for over-the-counter has a slightly different interpretation and safe means in OTC land that a drug can possess no great harm if it's used at its labeled dose and this is kind of something where you see a drug like dextromethorphan which can be actually be be abused if you took it and super high doses you not make is another similar instance if you took it super high doses you get a side effect profiles similar to ketamine so if it's taken and it's labeled dose and it's considered to be safe at its label dose then it's safe to be marketed as an over-the-counter drug these role is granted to them by the Food Drug and Cosmetic Act they regulate four things they regulate our food supply to ensure that it is safe from adulteration and disease they regulate our drug supply to ensure that it the drugs are effective and simply safe they will go over clinical trials and and everything to make sure that those drugs are good to go they ensure that our medical devices do not pose a safety risk and we'll talk about those in a little bit and that our cosmetic supply does not pose a health safety risk to the general public the FD&C has had several amendments over the years the first one that we talked about is going to be the durham humphrey amendment it was passed in 1951 and it requires the use of the federal legend we now see it in pharmacy today where the federal legend is that rx only that's listed on the bottle that is considered to be the federal legend at that time in 1951 it said federal law requires us to be dispensed by prescription only it really means the same thing but that took up a lot of space on a label and rx only takes up only a couple of centimeters as best it does actually allow for refills on medications pursue it to a physician's order and it for the first time we actually see where doctors are allowed to give verbal authorization for a prescription to a pharmacist the CAF however Harris amendment was passed in 1962 and this was the thalidomide amendment the FD&C the amendment here actually now required clinical trials of medications to be placed before the FDA will put its stamp of approval on there now it did make a requirement that said if a drug has already been proved to be safe and effective then it does not have to go through clinical trials and most of the medications at this time were considered to be safe and effective so the FDA just put their stamp of approval on it and let them slide anything that they had doubts on they made him go through clinical trials and again safety and effectiveness must be proved for all new drugs and that process takes about five years right now then we have the Orphan Drug Act that was passed in 1983 and that was designed to help drug manufacturers develop drugs for rare diseases and they get all kinds of benefits for this so they'll get tax benefits to fund the research and development of the formula they'll get enhanced pens so whereas you wouldn't have the typical you know five to ten years they would give you a little bit longer right now there are on that list 3519 available drugs for development and the FDA seems to be accepting about one-twentieth of that so they're really really is a low approval rate for these drugs Hatcher x-mansion came in a year later and this is a price control act it created the abbreviated new drug application process for generic drugs the first company to file and and gets a hundred and eighty days of market exclusivity so a hundred and eighty days you're allowed to market a drug without actually having any additional competition and we see this all the time when a torva sent and went generic several years ago Pfizer got their subsidiary to jump right in and file the first day and that gave them a hundred and eighty days essentially of extra patent protection on their drug before everyone else jumped into the market and what you end up seeing is that the price will go down just a smidge the first time around and then when those six months are up and everyone else jumps into the marketplace you'll see that the price goes down substantially this also does set out the length of time a drug manufacturer gets brand-name exclusivity and that is a set twenty years from the day that the patent is first filed so if you file a patent and it takes through seven years to go through clinical trials you only get 13 years of marketing exclusivity if you go through clinical trials and it took you 18 years to get your drug approved then you have two years of market exclusivity and a generic drug companies can jump right out in after that so they really have set out the amount of time that Briony manufacturers have really got exclusivity and we are really now seeing that law kick in the prescription drug marketing Act in 1987 was passed and it was really a distributed distribution control type legislation and it is designed to prevent distribution of drugs that have been counterfeited adult 'red drugs that were expired misbranded hospitals are not allowed to resell their drugs so once they get something in they're stuck with it unless it goes back to their original wholesaler in subsequent legislation they have set out exactly what those terms are and some of those laws are just as recent as 2013 and we'll get into that in just a moment other things the prescription drug Marketing Act did was is to set out what the rules were for television advertising for example so advertising direct consumers was a very key piece this legislation the User Fee Act was passed in 1992 and this was to respond to drug manufacturers saying the FDA's acting way too slowly and in 1992 going through 1999 we see the highest number of drug approvals and it's in response to this act so the FDA said well fine if you want drugs to be a proof faster you're gonna have to throw some money into the problem so what this does is it sets out the application fees and those fees are substantial they're for a new drug almost two million dollars just to submit the new drug application and that is to fund the additional staff necessary at the FDA in order to improve the amount of time it takes for a drug to be processed they have since gone from five years it was two years once your NDA was sent in to get approved now it's down to as little as 10 to 11 months and this only stays in force as long as the FDA complies with those regulations in 1997 the FDA got a Modernization Act passed it provides an exclusion on FDA approval for compounding medications and that still is an effective through today meaning if I am a compounding pharmacy meaning I'm a pharmacy that actually makes medications customized for specific patients I don't have to go get FAA approval for those medications it also eliminates bans on off-label use prior to that getting do it that ban actually only applies to the doctors and the pharmacies the the drug company itself cannot tell you the off-label uses for a particular medication and it does also allow access to investigational drugs for patients with terminal illnesses again that don't do you no harm thing that still applies but we can now have patients using investigational drugs the last major piece of legislation that was passed that really affects pharmacy is the drug quality and security Act of 2013 this is a response to a company called New England compounding center and New England compounding center was essentially acting as a manufacturer under the guise of being a compounding pharmacy so as a compounding pharmacy I don't have to go get FDA approval for each and every single drug I make what any CC was doing was as they made large batches of medication and they cut corners doing so so when they did people died my home state of Michigan for example received several doses of medication that came from NEC C and nineteen people have since perished as a result of NEC see acting as a manufacturer when it wasn't supposed to so it's out some restrictions for the compounding pharmacy industry one you cannot do office use compounding in bulk unless you register with the FDA the FDA now calls that an outsourcing facility so it's not a compounding pharmacy you cannot copy a commercial product now that was an under stood rule before here it is now hard fast written into the law pharmacies must now have strict adherence to the United States pharmacopoeia guidelines on compounds so the FDA says thou shalt follow us P and most states now actually have a similar law on board as well they also created a list of drugs that are do not compound medications and those drugs are slowly added and they are either a safety risk for employees to compound they pose a safety risk to patients if they got out due to an error they are not listed in the United States pharmacopoeia or national formulary or they are drugs that were pulled from the market for safety issues those are all on that compound list and finally all drugs must be listed in the USP or national formulary if a drug is not in there the FDA has to grant special permission for that drug to be compounded and the other part of the drug quality and Security Act is that it requires drugs to have a proper chain of ownership which means each pharmacy must document where they got their drugs from that particular wholesaler must document where they got that drug from and the main all the way back to the manufacturer so it has to go all the way back to the manufacturer it's called track and trace you'll hear that buzzword in pharmacy going forward most of the provisions of that particular piece of this law have not kicked in for the individual pharmacy yet wholesalers are on board manufacturers are on board but the individual pharmacy itself not quite there yet the FDA does regulate new drugs and there's a very stringent process for how this happens all new molecules considered to be new drugs must submit an investigational new drug application now the FDA does not specifically approve or deny these applications unless they have our problem with this drug and the they act within 30 days of the application at this point once the FDA fails to act on an investigational new drug application the drug manufacturer is clear to file their patent and that patent is applied for prior to clinical trials starting now that patent is only good for 20 years from the date the patent is filed so again when we're talking about the hatch-waxman act we were specifically taking a look at the amount of time a drug manufacturer gets exclusivity so again if it takes them ten years to go through clinical trials they get ten years of patent exclusivity before the generic companies can come in and chop the price of the drug so it's very important for drug manufacturers to go through a very speedy and efficient approval process finally once they get their patent they can begin clinical trials phase one is testing new chemical to ensure that it is safe for human consumption they can actually do this particular part of the process before they apply for their patent so phase one's usually always done by the time the patent is applied for because of cost money to apply for a patent and if the drugs not going to be safe for human consumption there's no point in applying for a patent phase two is after the patent is applied for it phase two uses larger population of people to ensure that the drug is safe for use and is also effective most drugs will fail here because of a lack of effectiveness so there's a lot of medications that never ever make it past phase two clinical trials phase three is where that's the drug against a placebo basically a sugar pill to ensure the drug actually treats a disease and works as planned again there's another number of drugs that fall out of the process here and never make it to the new drug application process so the drug manufacturer is taking a very large gamble that this is all gonna work out because phase three is by far the most expensive process of clinical trials once you get past phase three and you have enough data to say to the FDA that this drug is safe and effective and its risks outweigh its benefits here's my new drug application and all the data that goes along with it the phase three clinical trial usually is done within consultation of the FDA once they file the NDA then the FDA takes over and decides whether or not to approve the drug process takes approximately ten months and once they get approval from the FDA they can go into the marketing phase of a medication and they go through phase four of the clinical trial process phase four is known as post marketing monitoring and for a period of time a drug is monitored to make sure that it is indeed safe and if and if there's any safety issues at that point those will come into play let's talk about breathing new drug applications abbreviated new drug applications are used by generic manufacturers to gain approval for their drugs now this differs from the new drug application process in that they don't actually have to go through clinical trials in order to prove that their drug works that was already done by the Pioneer manufacturer in this they have to prove that their proposed generic is going to be the same dose the same dosage form and has the same really structure as the original drug they also have to prove that their manufacturing processes can provide a consistent and safe prosopis product this will create a bioequivalence rating to new generic drugs bioequivalence ratings are then published in the orange book which is available online if you go to the FDA's website and search for orange book you can look up the bio equivalency ratings generally speaking anything that is a grade a bioequivalence is considered to be bio equivalent to the brand name anything great being below is not and you do need to check with your each individual state as to whether bio equivalence is required my particular home state in Michigan is not what's considered to be an orange book state so if the FDA pulls bioequivalence for any reason on a particular generic drug manufacturer that does not affect me in Michigan but in other states it does biologics the biologic class of drugs includes five classes of drugs vaccinations anything that's made from human tissue anything that's made from human blood products such as rural gam would be in that class of drugs anything that has recombinant DNA like lantus for example would be an our DNA drug anytime you look in the generic name of a drug and it starts off with our DNA or ends with our DNA those are recombinant DNA drugs and those fall into the biologic class of drugs because they actually change the DNA structure within a human being and last are the immunomodulatory drugs and those are the the biologic class of drugs that we know and love today the drugs that treat cancer and rheumatoid arthritis and Crohn's disease and plaque psoriasis for example those all are biologic drugs as well they go through the same process of a new drug approval but they do so under the application known as a biologics license application last we're going to talk about medical devices and I'll talk briefly before I get done with the slide about nutritional supplements because they can have a little change in the rule structure as well medical devices what you really need to know are there are three classes of them this particularly comes into play if you work in hospital pharmacy in retail pharmacy this really doesn't affect you too much there are three classes and medical devices class one is subject to the least amount of control class 1 medical devices were are something that you typically see in our retail pharmacy these would be things like band-aids exam gloves joint braces things that really don't have a harm potential to them unless they were not sterile for example that would be the real restriction class to medical devices must prove that the device will not cause injury and these are things that might have a problem if they weren't regulated a little bit powered wheelchairs yeah I would want to make sure my powered wheelchair isn't going to like flip out tip over or or just flat-out eject me if I were to stop suddenly for example IV pumps I would want to make sure that that provides a consistent dose in the pump rather than dropping a hundred and cc's of IV fluid right into me and then waiting 60 minutes for the next 100 CC sees that would be really bad syringes are also in here that's really a sterility thing and also to make sure that you have a quality manufacturing process because the last thing I want when it comes to a syringe is a blunt needle a class-3 are the most restrictive and these are generally needed to support life so a couple of examples that you can see here are a ventilator I would not want my ventilator to fail if I were in a hospital and in need of it because if I stop breathing I die same thing with an AED machine I want to make sure that's gonna deliver a shock now an a/d machine I actually have an alternative it's called CPR but an AED machine actually increases my chances that my heart might start beating again before I get to a hospital so that is a necessary thing another example here would be what's called an auto pulse an auto pulse is basically a CPR assisting device you'll see that with paramedics nowadays and what they do is is they basically slip this on around you and it does CPR for the paramedics so they can concentrate on other things like getting you to the hospital so those are very essential to support life while we get you to treatment and that's why they are considered class three devices now the last thing I'm going to talk about and they didn't make a slide for this is going to be nutritional supplements nutritional supplements are treated as food by the FDA so if you'll ever notice the back of a nutritional supplement label it looks like a food label and that's because the FDA considers them to be food not medicine so it's something that you have to consider when you take a look at nutritional supplements isn't that those are going to be food and you do have to watch on the backside of a nutritional label for a nutritional supplement because the dose that they list on the bottle may not just be for one tablet it might be for three so you do have to make sure the patients are aware of how to take it and that they take enough of it to get those listed on the bottle up next we're going to talk about the controlled substance regulations and the DEA is all related to controlled substance regulation and I look forward to your joining us for that thank you for joining us and we'll talk to you next time

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