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

Very clear and well done

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

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.

I still wonder how paxil got approved.

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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👐

It helps if you lobby millions of dollars as well

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.