Not All Drugs Get Approved the Same Way: Exceptions to FDA Rules

All drugs have to follow the same path to approval at the US Food and Drug Administration, except when they don't. Today, with the support of NIHCM, we're learning about the exceptions to the rules that can happen when drugs get approved. The FDA has several alternate pathways that can help drugs get to patients more quickly. As usual, the world is complicated, and there are upsides and downsides to these exceptional circumstances.
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[@damiettes7140]

Very clear and well done

[@jeremiahteague4670]

It would be interesting to view the cooralation data for member fees to the usage of these fast tracks

[@JS-lr7dc]

This is a great video, but it doesn’t cover two critical items that are especially topical as they impact the current Monkeypox outbreak: the Animal Rule and Emergency Use Authorization. This is relevant as TPOXX (the current Monkeypox Expanded Access drug) received approval for its Smallpox indication under the animal rule. On the other hand, Jynneos has received an Emergency Use Authorization for the subcutaneous injection method which has extended the vaccination supply five-fold. Moreover, if the Monkeypox outbreak continues, TPOXX could receive an entirely new Monkeypox indication under an additional Emergency Use Authorization.

[@Askify]

Transcription notes of the video: 00:00 with support from the nihcm the national institute for healthcare management we've created a three-episode series about how drugs get approved in the united states the exceptions the normal rules of approval and what some major 00:11 issues have been and how things have changed or may change in the future in the first episode we discussed the drug approval process from the discovery phase to what happens after approval in this second episode we talk about what 00:23 happens when the usual rules don't apply that's the topic of this week's healthcare trial [Music] the ways in which drugs get approved in the united states have always been an 00:38 issue that people feel strongly about some believe that the fda is too slow depriving people the chance to take life-saving medications that might make a difference others believe that the fda is not careful enough approving 00:50 medications that are still risky or dangerous or where the risks potentially outweigh the benefits as we detailed last week it can take up to 15 years for a drug to get from the lab to the market and only a small number of drugs make it 01:03 that far there are however exceptions to the rules some of these exceptions aren't too controversial like abbreviated drug applications these are shorter ways to gain approval for generic drugs when the 01:15 brand name drug has already gone through the original approval process in this case drug makers just have to provide proof that their generic version is comparable to the initial drug in things like dose and strength think of things 01:27 like the many forms of ibuprofen that are available in addition to advil the original brand for new drugs though there are several pathways through which they might get approved more quickly or receive more support from the fda this 01:39 often applies to drugs for serious or life-threatening conditions for which no other treatment is available one of these pathways is called accelerated approval after an investigational new drug application or 01:52 ind is filed which we described in episode 1 a drug may qualify for this accelerated pathway and be approved for limited use based on surrogate endpoints that means markers that predict a clinical benefit but don't actually 02:06 measure a clinical benefit even when granted an accelerated approval the drug maker still has to move forward with what are called phase 4 confirmatory trials to prove or not the medication's ability to affect actual clinical 02:20 endpoints but making the medication available in the meantime lets patients without other options try it much sooner than they would otherwise normally be able agile a drug for alzheimer's disease was approved via this pathway in 👐Install Askify chrome extension to get full transcription👐

[@Leumas34676]

It helps if you lobby millions of dollars as well

[@Artifying]

Good faith question: are you referring to a specific example?

[@Leumas34676]

@@Artifying pfizer

[@raiden72]

I still wonder how paxil got approved.

[@offmefaceken4547]

Money, if a person can fake a symptom to get whatever drug, some pharmacies has faked trials to get the drug to the person. It's human sadly, greedy human ways

[@dailydoseofmedicinee]

👋👋

[@bernadettehurst6541]

Why can't the FDA approve the sunscreen filters that have been used in other countries for many, many years. They are far superior to any of the US sunscreens. How many skin cancers could we avoid by having sunscreens that worked better and are far more comfortable to wear? I'm on my 4th round with melanoma and have to order my sunscreens from overseas.

[@rabbitwho]

what sunscreens are those? I am not in the US and it's very uncomfortable wearing sunscreen at work, sensory hell i thnk the "allow it to only be sold in pharmacies" option should be used more often. We have pharmacies here struggling to make ends meet and yet they just banned things like st. john's wort and valarian outright only because they are dangerous for a small minority of people. Pharmacists could handle that and it would help them pay their rent: talk to people, warn them, talk about options, contraindications, and sleep hygeine, recommend therapists etc.

[@bernadettehurst6541]

@@rabbitwho I like Japanese sunscreen the best. Kose Suncut is a great body sunscreen but I use Skin Aqua on my face because it doesn't make my eyes water and sting. I order them in February and stock up because they sell out this time of year. Both are spf 50 pa++++ unscented and have a slightly water consistency. Once you rub it in you don't feel it at all.