FDA & DEA



hi I'm Joshua your instructor and today I'll be giving you a quick overlook of the food and drug administration or the FDA and the drug enforcement agency or the DEA and their respective roles in regulating drugs that are available in the United States first though a little history back before the FDA and DEA were established there were no drug standards whatsoever for a good chunk of time there there was nothing requiring a manufacturer to be honest about the labeling of the drug so essentially a label could claim that a drug could cure cancer and that it had a whole bunch of stuff in it and at the end of the day there might just be water and vinegar in that in that bottle in 1906 the pure food and drug act was passed and this required that a couple of things one that drugs meet minimum standards of strength purity and qualities so essentially something that was like any label claims had to be at least backed up by the agent being there and at being of a certain purity like without excipient toxins and of a certain quality as well additionally this act required that dangerous ingredients had to be listed on the label at that time there were 11 dangerous ingredients recognized by the US government and these ingredients were things like heroin and cocaine and marijuana you could still buy these agents over the counter there was no restriction on that at all but the labeling for these drugs actually have had to indicate warning this contains heroin that is considered dangerous by the authorities of the time um so still quite a different landscape than there was today in 1937 there was a widespread national disaster regarding an antibiotic called sulfanilamide sulfanilamide is great for treating a variety of infections including pediatric infections however a company that was marketing this decided to target the pediatric or child population by creating an elixir that tasted a little bit better than other things that were available at the time one of the ingredients of this elixir was something called diethylene glycol or antifreeze if you're using the common name and it works out that this is rather toxic when you take it by the end of nineteen thirty-seven about a just over a hundred children had died as a result of ingesting this antibiotic elixir and that created quite a public uproar that eventually led to the creation of the FDA in 1938 we created the FDA that's that's when it first hit the scene and by 1962 there were a variety of standards in place that had never been there before for example we had categories that indicated whether a drug was available over-the-counter or whether it was a prescription or legend drug legend in this case just means that every label for a prescription drug had to have a statement saying that federal law prohibited dispensing this drug without a prescription that's all legend means and it's virtually interchangeable with prescription drug in in this scenario additionally the FDA began to require that drugs be shown to be both safe and effective in 1938 when it started it was just safety that they required because it was in the wake of a national disaster but by 1960 to the FDA decided that they actually wanted drugs that were marketed in the US to be shown to be effective for the conditions they were treating the FDA now approves all new drugs before they are marketed and clinic requires data that is generated by clinical trials that illustrates that a drug is safe to take at therapeutic doses and that that drug at therapeutic doses actually does some benefit to you lowers cholesterol or blood pressure or any one of a number of things like that in addition the FDA approves new generic alternatives for brand-name drugs that are already on the market in this case all the manufacturer really has to show to get a new generic drug on the market is that a 20 milligram tablet of their drug contains exactly the same or very similar amount of that of the active ingredient that the brand-name medication also contains the FDA today has a variety of responsibilities they insure of course the purity quality and safety of marketed drugs they ensure that generic alternatives are similar in potency and strength to their brand name equivalents they require black box warnings on potentially dangerous agents these are agents that are therapeutically useful but that have some rare severe side effects like liver failure or asthma related death in this case the FDA will still allow that the drug is able to be marketed in the US but there has to be a warning on the drug information packaging that indicates what the severe risks are and allows both prescribers and hopefully patients to make an informed decision about whether or not they want to use that drug in addition the FDA investigates and prosecutes to two aspects of drug availability in the u.s. one is misbranding and the other is adulteration misbranding is essentially an issue of the labeling for a drug having inaccurate information so if you get a bottle that says lipitor on the outside but when you open that bottle up it has viagra that's considered to be misbranding there are several other examples of misbranding too but that's that's the basic is that the label is not accurate pertaining to what's actually in the bottle adulteration on the other hand is the distribution of drugs that have been expired that have been exposed to elements that is reduced or obliterated their efficacy anything that changes the actual constitution of the drug is considered to be adulteration and that is something that the FDA can prosecute as well additionally the FDA has some oversight over nutritional supplements they can't require them to be safe and effective before they're marketed but if enough complaints come in from consumers and health professionals regarding the safety of a nutritional supplement the FDA can investigate that and potentially remove that that supplement from the market but it's an after-the-fact kind of thing bad things happen have to happen in order for a nutritional supplement to be investigated and removed by the FDA the DEA has a completely different scope and a completely different timeline as it turns out before 1973 there was no such thing as a controlled substance whatsoever um in 1973 Nixon created the DEA and his goal and I'm quoting here was to combat an all-out global war on the drug menace essentially they were trying to find different ways to address drug abuse in the United States and curtail it this started on it what by government standards at least is a shoestring budget of 75 million and that's expanded to over two billion today which should give you some idea of the scope of the DEA its involved in a lot of different things with that being said when it comes to drugs they're involved in the regulation of what is legal and illegal and certain subsets of what is legal um the DEA is responsible for identifying a drug as an illegal drug these are called control these are in controlled substance schedule one and their drugs that are illegal because they are considered to be dangerous have a high potential for abuse and there's no legitimate medical use for them um the the DEA then investigates and prosecutes everything pertaining to illegal drugs whether it's the use or manufacturing of those drugs mostly they're involved in distribution and manufacturing because it's a broader scale sort of thing they also regulate the sale of legally available controlled substances and require certain documentation and requirements of people who purchase them and inventory requirements all kinds all things pertaining to controlled substance distribution in the United States a quick word on controlled substances a controlled substance is essentially any drug that can be abused there are two notable exceptions from this category and these are alcohol and tobacco i'm sure that nobody would argue that both of those drugs are potentially dangerous have the potential to be abused and have no known medical use but they curiously do not show up on the DEA is controlled substances list virtually any other drug that can be abused does show up there and this is where the DEA comes into play they can determine that a drug is schedule 1 which means it's illegal to sell in the United States or have in the United States because it is dangerous and abusable and not medically useful all the way down to controlled substance schedule 5 which are drugs that have very low potential for abuse but still have some schedule 5 drugs are actually available some of them are available over the counter here in Idaho um but that's that's a different story technically the DEA does not assign the controlled substance schedule this task is left to the Attorney General but the DEA makes recommendations and it's the Attorney General does not interfere with those recommendations he essentially just goes along with with what the DEA tells them to do these drugs controlled substances then are stratified by abuse potential and medical utility controlled substance schedule 1 is no medical use and high abuse schedule 2 is really high abuse potential but it is medically useful and this includes drugs like oxycontin adderall is a schedule to drug and there are a total of five schedules every time you move up a schedule you go from two to three the drug becomes less abusable three to four the drugs are less abusable still and so on and so forth all of the controlled substances that are available in the United States for sale though have to be shown to be medically useful otherwise they wind up in controlled substances schedule one that is the quick and dirty primer on the roles of the FDA and the DEA in drug regulation and distribution in the United States if you have any questions regarding this whatsoever please use the ask my instructor link in blackboard thank you

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