How Does the FDA Approve a Drug?

Have you ever taken an over the counter medication for heartburn? How about an antibiotic for an ear infection? At some point pretty much all of us have visited a pharmacy to pick up a drug, but likely didn't consider where these drugs come from or how they are made.
Whether you're talking about something for seasonal allergies or your grandparent's arthritis medication, the act of bringing a drug to market is long and complex. I'm not an expert, but HCT intern Rachel Hoffman is, and with her help, that's the topic of this week's Healthcare Triage.
For those of you who want to read more, go here:
theincidentaleconomist.com/wor...
John Green -- Executive Producer
Stan Muller -- Director, Producer
Aaron Carroll -- Writer
Mark Olsen -- Graphics
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[@ziphomokoena3551]

Thanks for this.I needed a short video that summarised a very complex clinical trial process in an easy-to-undeerstand way so thanks again!

[@odimaglasang]

Thank you very much sir. This lecture has immensely contributed to the content inside my class. Very grateful.

[@rocqua]

Way to go for making me feel old when putting '15 years ago' into perspective.

[@ma.methloreto6843]

Thank you for the information. I find this video the easy way to understand Chapter 5 of my pharmacology book. 😊

[@TheRobinator143]

Pharm student here, this is my dream, assisting in the development of a new drug. People criticize the industry but often don't have any idea what developing a drug really encompasses.

[@SicaGR]

That's the whole reason I watched it & shared it. I just finished MA school and find the same thing among many people I know. I found the post aproval step to be very intersting as I didn't know they did that at all.

[@smilemor-phony5964]

Robbe, boy do you have a lot to learn. Drug-Induced “Iatrogenic” Disorders: The Third Leading Cause of Death in the US and Britain Definition of an “iatrogenic” disorder: A disorder inadvertently induced by a health caregiver because of a surgical, medical, drug or vaccine treatment or by a diagnostic procedure. Iatrogenic illness/death is the 3rd Leading cause of death in America. “Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare.” Dr Goetzsche boldly states that iatrogenic deaths should be listed as # 3 in both Europe and the US. In his 2015 companion book, Deadly Psychiatry and Organised Denial, Goetzsche makes the same points about psychiatric drug-induced deaths. Why don't you talk to few psychiatric drug survivors if you really want to know about their 'new' drugs.

[@lostboy3080]

@@smilemor-phony5964 Please cite your source. Its very easy to just say something as "facts" without citing source. For a drug to be approved it takes a lot of safety, efficacy and purity data. You, can criticize the pharmaceutical industry for their ridiculous prices, that's fair criticism.

[@lostboy3080]

@@esmolol4091 Scientists who work in R&D, do not really have that much say about the price of the drug, Ultimately, the management decides the drug price. The way drug prices can be reduced by having more generic and biosimilar drugs being made available.

[@timhall5900]

Nature is true medicine, not pharma drugs

[@healthcaretriage]

How are drugs approved for the market? That's the topic of this week's HCT: kzbin.info/www/bejne/jYbWgGmGfcSCa5Y

[@InorganicVegan]

Okay, that is way too hard. We need to streamline the process to pick up the fucking pace and let scientists work.

[@InorganicVegan]

I think that experts would be able to get by with a shorter process. They know what they're doing.

[@MatthiasKohl]

Inorganic Vegan No that's precisely the reasons why we have a complicated scientific process for everything in science. Scientists are human, they get stuff wrong, but they know that they are. Expert is just a meaningless word thrown around by Sales/PR people.

[@InorganicVegan]

Ma Ko. That is the stupidest comment I've ever read. "Expert" is meaningless? So completing a doctorate is meaningless? Proving your competence is meaningless? Fuck off. Fifteen years is overly cautious paranoia.

[@AlucardNoir]

Healthcare Triage You should also do one on why a regulatory body approves drugs.

[@captainremo]

Very well done general overview of the FDA approval process

[@TheDilettante]

I would love an episode of HCT about psychosomatic diseases and conditions: which ones are thought to be more psychosomatic than biological, what's the breakdown between the psychological and biological contributors for psychosomatic diseases, and how to diagnose them on an individual basis and how to design RCTs to test for them.

[@AssClappicus]

Thanks Aaron!

[@danicafriesen4232]

Hello healthcaretriage! Thanks for the informative video. I'm wondering if you could do a video about FDA approval of medical devices?

[@sunnyboynfs]

Regulatory Affairs Associate here.. No matter how much I learn about drug and medical devices rules and regulations, there’s always something more to learn and revision to do..

[@wesleycurrence2025]

Great video - informative and engaging. Thanks!

[@luciacarey4370]

The length of time it takes to make and test a drug before it goes on the market to patients is new to me. All of the testing and analyses makes me feel better about the drugs that do get approved. The only issue that some people may have a disease where there is that the drug seems to be working, but hasn’t gone through all the testing yet and is not available. Those people with that disease may lobby for early accelerated drug approval to have access to a drug that may work for them. This is a very controversial topic because the side effects and whether or not the drug actually will work is usually unknown. It depends on the situation and specifics of the drug and disease, but usually I lean towards allowing accelerated approval for drugs that are promising, especially if the disease is life threatening. The patients who would use the accelerated drug would be made aware that it may not work and could possibly harm them. For some people, this is their only option and they are at the point where they will try anything.

[@mnjnthks7578]

Very informative video. Awesome

[@TomatoJoe11]

I was the thousandth like! Love these videos. Excelent content.

[@orangeempathy]

Brilliantly made!

[@saravtt]

Very informational. Thank you!

[@gmpworld3113]

Really informative! Great video!

[@hyojinlee]

Thank you for this video!

[@quinnp8493]

A kind of interesting topic that goes along with these phases is who often conducts them. I'd love a video that goes in more depth on this but as a crib notes version There's a lot of public funding that goes into discovering drug targets and even promising molecules, this work as such is often performed in Universities. Biotech startups emerge from this when somebody finds something promising, occasionally it will be a student looking to strike it out as a drug developer, or the drug may be licensed to a small company that attempts to get it through clinical trials. This is where you get lots of companies you've never heard of working on drugs Normally later into a successful trial one of the large pharma companies (Perdue, Johnson and Jhonson, Phizer etc) will often try to buy out these smaller drug companies and handle the complex translation from a drug nearing approval to a drug on the market.

[@dylansands2627]

Wait how can someone make an arguement that it is too easy to get approved when it takes about 15 YEARS to get approved?

[@ArbitraryDoom]

Dylan Sands Maybe it is too easy to falsify trail data?

[@In2hardcore]

Dylan Sands These days a lot of trails are conducted overseas in countries where the costs are lower, but the integrity of the trials have a greater chance of being compromised. There is always a compromise to be made when ever a change in the process is made. While there is certainly things that can be done to reduce costs and time, not all the things we have done in the past to achieve such have necessarily been for the best. I would assume part of the too easy to get approved argument is due to that.

[@Silverizael]

In2hardcore Regardless, the US still has one of the most rigorous and lengthy legal testing systems anywhere in the world.

[@In2hardcore]

Silverizael Agreed, my comment was only meant to suggest there was a lot more nuance to the topic. Also, maybe that the people who suggest it is too easy may not be 100% incorrect in some aspects of the process.

[@elliottmcollins]

Dylan Sands It's easy to imagine that the process is *both* inefficiently long *and* vulnerable to mistakes or corruption at certain stages.

[@jazmingarcia6540]

I'm currently taking Pharmacology and this was extremely informative. Thank you. also, Can you please tell me where you purchased the Skeleton Teddy Bear in the background? It's ADORABLE!!!

[@rania9912r]

Thank you , so simple

[@christiaannoot9938]

Great video. Very informative. Obviously the way it should go....although apparently it doesn't always when we follow the next pharma scandal in the news. Still super cool vid!

[@spectech73]

As usual, great video. Love that you actually used "fancy shmancy". I feel like we're not using enough Yiddish slang anymore these days, and hearing you say it was refreshing. Keep up the good work!

[@holly9321]

Our society has become so dependent on medicines and it seems as though there is always a new drug, either name brand or generic. So many people just go and buy over the counter drugs to help with symptoms or trust their doctors when they are being prescribed a drug. It seems as though no one ever questions where the drug came from, how it is made or even how safe it is. I myself have never asked these questions or thought twice before going and picking up a new medicine. I will say that after watching this video it is good to know that the FDA does extensive testing on new medicines before releasing them to a public. I never realized how many trials a drug had to go through before it could be deemed as ok for patients to take. It is great that these measures are being taken because if prescribed a wrong medicine a person can become serious harmed by it, whether it messes up their cognitive process or how they move physically. Not only is prescribing a problem but with new drug they have to be careful on what side effects are possible because the side effects cannot outweigh the good the medicine does. I do not like that cancer drugs are being tested on patients who are not responding to normal treatments. I get why it is being done but it just feels as if the weak the desperate are being exploited because they are desperate and willing to try anything. As I said before I understand why they are chosen and it is because they are desperate and are the perfect people to test it on as they already have the disease and nothing else is helping. I just do not like that people with such awful diseases are being used as guinea pigs. I found it very interesting as to how many times data on the studies has to be submitted, reviewed and approved before it can actually go out and be sold. I was quite shocked when he said that it takes fifteen years on average for a drug to be approved. But then again it is that such extensive measures are taken to be sure that drugs people will be buying are safe.

[@jl-ik6fs]

MSB got me here (ASX stock), their shares went bust by 31%, as FDA questioned their data..... im here to consider if its a good investment, but first i need to understand how FDA approves drugs.... random hey... thanks for the knowledge!

[@BrianAThomas]

May I suggest a vid on Direct-to-consumer Prescription Drug advertising, the US vs most of the rest of the world?

[@carla.m.9356]

Decent summary, but it may be misleading. Yes, the drug approval process is--and should be--rigorous. This doesn't mean concerns about corruption in and ineffectiveness of parts of the process are unwarranted or that costs in the US (relative to other developed nations' drug development, manufacture, and distribution costs) are justifiable.

[@fatimahalrobayeh7083]

2019 VERY USEFUL VIDEO, THANK YOU!

[@LeoAngora]

I was expecting you mention the crucial difference between a phase 2 study and a phase 3 clinical trial (methodological rigor, not only sample size). Many physicians, institutions and even countries (where regulations are not that strong) make clinical decisions based on phase 2 studies.

[@notmicrowavesafe]

This was amazingly informative and well thought out. But dude, Aaron... ...spoiler alert man.

[@donfolstar]

Great video, though some more numbers for context would have been nice. What % of drugs submitted for an IND and NDA are approved/denied? In other words, are those rubber stamps or is the FDA taking no prisoners? The process takes an average of 15 years, but what is the median? I imagine some drugs may have been bouncing around the process for decades skewing the average.

[@angiehaumont8158]

I was trying to figure out how to send a private message via the KZbin page or the Facebook page and on my phone was not able to find one. I have been a fan of this channel since it was suggested from Scishow (I think?) May I suggest the topic of Glaucoma as a subject for an up coming video? I have been battling this since 6 years old and would love to hear a healthcare providers view on this chronic disease. Thank you for your time Yours truly Angie

[@DarthLoompa]

I wish you had discussed the conflicts of interest inherent in the process. I also think it would have been good to mention that safe and effective does not necessarily mean safer and more effective than the existing drugs.

[@adrianbulfon8430]

I think the system could dramatically be improved by having different "grades" of approval. Where the safest or most effective drugs get an "A" rating and drugs that are less effective and safe get lower (i.e. "B", "C" etc) rating. Because some drugs that dont reach stat significance in efficacy do work for a good percent (20-30%) of people. And if you are refractory to all other meds, maybe taking a class B or C drug would be better than taking none at all

[@michmash7888]

If they did a video on natural remedies/supplements, it would be remarkably short: 1) Find substance you'd like to sell and think up a snazzy name. (Inclusion of substance in actual product is optional.) 2) Develop eye-catching packaging, being careful to NOT make any direct health claims on it (structure/function claims are strongly encouraged). 3) Bring product to market and cross fingers that not too many people become ill or die from it, because then the FDA eventually will intervene.

[@JenniferJiang2013]

I just googled this from Mayo Clinic: "Herbal supplements are regulated by the FDA, but not as drugs or as foods. They fall under a category called dietary supplements. The rules for dietary supplements are as follows: Manufacturers don't have to seek FDA approval before selling dietary supplements."

[@PeaceNinja007]

@Michmash - As someone who has healed myself using natural remedies, and learned from others who have done the same I strongly suggest you reconsider your position on natural remedies. i used to do the same until I had my own experience.

[@Animelily]

I actually was familiar with this as I have a rare genetic disease that I had the opportunity to join both phase two and phase three trials for an experimental drug to treat it. Currently that drug is languishing in one of the later phases of approval by the FDA and it's driving me CRAZY! It's already approved in Europe and I know rare disease drugs are not on the top of the FDA's radar, but cmon! It's been almost four years since phase three trials. The community of people who have EPP (my disease) are all pretty close because it's so rare (and we're kind of hermits) and everyone who had the control verses the actual product KNEW it, to the point people were pretty excited if they got some mild nausea because they knew they weren't in the control group. And it's STILL languishing! There are actually members of the community who have purposefully made a short trip overseas just to get treatment in places like Switzerland. I know safety is super important...but ARG!

[@simplesimple4247]

If a drug has been tested on animals in another country and the company would like to export it to the US, does the drug need to undergo another animal test in the US or the current test results are honored by FDA?

[@RxGuy95]

Good video, but lacking info on Biologics and how they are developed (BLA's vs NDA's)

[@mickeysmcgee]

why do you and test tube have the e xact same title (effectvely)

[@winmine0327]

The FDA would rather reject effective drugs than risk allowing an ineffective drug. There's no bad press for rejecting or postponing a drug's approval, even though this is deadly.

[@Tan8ous]

Where would I find the NDA approval form on a company’s website? (Usually)

[@johnsniper13]

If we find ourselves in a crisis such as an epidemic or a pandemic and there is a promising substance which is claimed to be effective, are there any kind of fast procedures for the drug to be approved ?

[@mariusfourie6326]

Vaccines (like flu) are reformulated every year, so it cannot go this approval process. Which medications are exempt from this multiyear process?

[@TisiphoneSeraph]

Dude how do you apply to be a HCT intern?

[@TheMoMoBigGC]

Can you do faith healing or link me to some studies about it?

[@hasabobashir8543]

Thanks

[@drvacuumbag]

Volume seems a bit high, but maybe that's just me.

[@robertvdhill367]

In what part of the process do they determine that "people with condition X should not take this drug?" Do they have to cross-check people with the disease with every other combination of conditions?

[@Lexisrae122]

Is this still accurate?

[@matcha3257]

I'm curious how FDA approval compares to the Canadian system. I've heard that some of the testing is different, but don't really know the details. Many drugs get cleared through both, but what does it mean when a drug company chooses to only go through FDA or Canada?

[@Silverizael]

matcha3257 Canada isn't as strict as we are in regards to how many safety tests need to be run. But the overall kinds of tests are pretty much identical.

[@raymondgaetano7290]

they should probably eliminate Fisher p tests and go to Baysian analysis of the data.

[@Oh_ELCapitan]

How does the FDA approve medical devices?

[@quatie]

Testtube news triage have just uploaded the same video.

[@trinathigapanich7792]

@1:39 whats that?

[@ovotro]

TestTube News released a video with the same name at similar time? is this a coincidence?

[@megathai]

Done better than testtube

[@user-ms8yn6oi7e]

Please sir help me

[@ragnarox16]

Brillant

[@brianmiller1008]

When a drug is approved and hits the general population they don't even know 50 percent of the side effects involved with that drug.

[@bsaver5942]

How do they approve a drug? $$$$ of course. They do no investigation.

[@mysticalvibe4241]

My big concern is lately all pharmacies seem to constantly change there generic drugs. A lot of these generics come from different countries. For example I was just diagnosed last year of ADD over a year ago. It was hell growing up not being treated. When I first got my generic for Adderal it worked great but within that year they changed to another generic overnight. It did nothing and had a bad side effects. When you question the pharmacy they always tell you it’s just in your head. It is the exact same. If this is true why do pharmacies constantly switch generics. Answer$$$ To find the cheapest. I looked up the generic and there were a lot of complaints over that generic. I realize every body chemistry is different however when there are unanimous comment that are negative you know your not crazy. My question is when these generic prescription are made in countries like Tiawan for example. How does there FDA work or do they even have it. Also is the fact Does are FDA even look into prescription generics before they come here?? I very much doubt it. There are way to many generics and competitors. I even worry if they have any of the key ingredients or formulas in them to work. For example maybe the placebo effect. How in the world would we even know? Let alone our FDA. I’m not just talking about my experience. It’s every generic drug out there on the market made around the world??

[@Cheekyst]

you need to mention PDUFA acceptance not just NDA acceptance in this process as that's another 6-9 months AFTER nda acceptance before it's cleared to even hit the market. NDA acceptance is less strenuous compared to PDUFA acceptance.

[@bangboom123]

Don't think the statute of limitations has quite run out on the first part of Game of Thrones.

[@literaryloser1]

If you're interested in this kind of stuff selling sickness is a good book

[@brianchia]

TestTube News!

[@gemsbyjackie5479]

15 years???? So what has changed since warp speed and covid treatments, vaccines?

[@monopalle5768]

public demand. Voters were scared.

[@SFGJP]

What's a drug?

[@elliottmcollins]

SuperFlyGuyJohnnyP Nothing don't worry about it just take this pill and see what happens.

[@radiobiologist]

Sertrürer was really brave.

[@bshay513]

We call this the drug pipeline. :D And why didn't you say you wanted a pharmacy intern? I've been one for 2 years.

[@davilyraleite]

Dr. Carroll, there is an interesting Opinion paper published by Nature Drug Discovery in 2012 talking about the costs in time and money to approve new drugs. It helps understanding why we have billions being spent on research these days, without having a significant number of newer drugs entering the market. This is the link: www.nature.com/nrd/journal/v11/n3/full/nrd3681.html

[@SlimThrull]

So the take away is eat chrysanthemums to treat lice? (No, don't do that. Though, apparently some varieties make delicious tea.)

[@user-ms8yn6oi7e]

Hi sir please help me my name is MOSAROF I'm from Bangladesh I'm 35 year old I'm suffering MND ALS disses one year please can you help me sir please

[@veganconservative1109]

The greasing of relevant palms?

[@daviddauterman325]

Opioids aren’t the best example to use Pal, and here in modern time $$$ seems to be the method more commonly used to achieve approval.

[@TemporalOnline]

How does one get an over-the-counter antibiotic? No wonder that bacteria are getting stronger...

[@starseedlightworker6539]

When it cures cancer with no side effects they don't approved it, but when it have millions of dangerous side effetcs and death they approved it

[@AsintheDaysofNoah]

Where are our drugs made?

[@timothy558]

So....who decides the price?

[@vanegbm]

+Double T the price is decided by the amount of money that the patient would pay for its condition. Thats why there are same active ingredients for different therapetutical indications which by the way cost different.

[@avoisin]

I know one of the hot new promises in the future is that instead on one drug for everyone, we can do better targeting. For example, perhaps a fancy cancer drug will work wonders for me, but the side effects might be lethal to you. Rather than say I don't get the drug, it'd be even better if there was some kind of screening-efficacy type test we could take to figure it out. I'm sure countless drugs haven't made it through trials when they really should have, if only we'd had a better way to predict who would get unmanageable side effects.

[@joslinnick]

SPOILER ALERT AT 5:45

[@sheepwshotguns]

Nick Joslin should probably say spoiler alert for anyone about to start watching game of thrones

[@gregkrupka4081]

That big mumbo means those who create also test thus we have recalls and fda isnt sued as they are merely observers of data and not at fault of trial mishaps

[@SanvelloSerapiega]

so am i the only one wondering how ever found out that lizard spit makes good diabeates treatment found out such

[@solath]

Cap. Orange Soghda McGuffiepans Those specific lizards eat only 5-10 times per year in the wild. Research into how they did this found that their endocrine system basically shuts down until the saliva they ingest with food re-activates it. They found the protein in the saliva also has an effect on humans by regulating insulin and glucagon.

[@coltorl]

2 weeks ago : Beard Last Week: No Beard This Week: Beard I DON'T EVEN KNOW MAN.

[@docnevyn5814]

Coltorl As he explained last week, shaving accident led to no beard. He and his wife prefer beard, so I'm guessing he's growing it back this week.

[@nolanthiessen1073]

Coltorl They often film videos a few weeks in advance. This could have been before his 'accident'.

[@yahudahintrudahtruetribeof7639]

Hmmmmmmm....... Interesting.

[@FNPetersen]

77.

[@Nox444]

Ned Stark is alive?! I knew it.

[@radiobiologist]

Loperamide is like paregoric 2.0 don't cross the blood brain barrier

[@edwardvytlacil8686]

Remember this? "“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.” Other studies have shown as few as 1/3 of results are reproducible.

[@budabbotlane6234]

If they are paid enough it goes through!

[@hoo-rei2746]

Bud Abbot Lane True! I stumbled across this. It's horrific a must watch kzbin.info/www/bejne/d4bTg6WlmsuKhs0

[@raptureangel5409]

SHOW ME THE MONEY!

[@zhangster11]

38

[@MrAtreties]

Gila is pronounced 'hee -luh'

[@docnevyn5814]

MrAtreties I've heard it both ways

[@georgecataloni4720]

MrAtreties It appears to be jee-luh to me.

[@MrAtreties]

Doc Nevyn Then you've heard it both correctly and incorrectly. I live where they are. I have streets near me named from them, a river, and a casino, all named from them. It's hee-luh.

[@docnevyn5814]

1) was making a Psych reference 2) I also live within the gila monsters natural habitat and have heard both pronounciations. Just because it is a big deal where you are doesn't allow you to dicatate how it is said elsewhere.

[@Ed-527]

Well as of December 21st 2023 I called 50 pharmacies trying to get my hydrocodone filled not one pharmacy has any. A lot of pharmacies that they're not even going to carry it anymore because of all the pressure from the DEA, here's what's funny you can't get it from the pharmacy but there are a lot of hydrocodone out on the market on the street. But the danger is fentanyl but the United States government and dea does not care if they did they would make sure there were no shortages for legal prescriptions from medical doctors for people in severe pain . You can go to any other country and not have an issue with pain meds only in America. America is becoming a banana Republic

[@juansanabria4266]

Who is here bc of covid-19

[@georgecataloni4720]

I wouldn't say hard, but it's certainly slow. People die while they wait too. So many change.org petitions about the FDA slowness. People should be able to volunteer for trials at any stage.

[@cminmd0041]

George Cataloni the FDA already has an expedited program for serious conditions. The indications for expedited research is that your drug must treat a Serious Condition, improve on Available Therapy or fill an Unmet Medical Need. And during the AIDS crisis they started the Fast Track process and it caused a lot of suffering. People facing a terminal illness should not be wasting the last physical, financial and psychological reserves they have on guesses and hunches. Possibly a parallel non-reporting open trial for Phase 3 clinical trials. Any earlier is just cruel.

[@georgecataloni4720]

cminmd0041 It should be up to the patient. It's not cruel if you do it to yourself, it's just a risk.

[@cminmd0041]

It should not be up to the patient. Patients should be offered the best, most effective medical treatment available. Dangling out the hope of unproven miracle cures is the last thing patients need. It is exploiting desperate people to make a profit. It is selling snake oil and has no place in ethical medicine.

[@georgecataloni4720]

cminmd0041 You can't say it is or isn't "miracle cures" before testing occurs. The decision has to be made, and you're just assuming people on their death bed won't make rational decisions. They could. But if they don't, it's their choice to make, not a doctor's. Doctors are supposed to help when asked.

[@tiffanyrahim8805]

Approve manageable amounts of marijuana and powder form of cocaine to be in CoCa Cola and traces of THC in burgers. Euphoria. TIP Harris, Troy, Dell, Sam, Reggie, Dion💙💙💙🙏🏾

[@user-ms8yn6oi7e]

Please 🙏 I

[@allencooper517]

Easy, follow the money