Epipen price jump

[OJsDad]

Once a drug started development, in my experience, one in eleven got to market.  Of the ten that do not get to market, you could spend tens of millions to half a billion dollars on them.  The sooner you kill a development drug the better.   One of our drugs that got to market, had to be pulled because it started showing severe side effects.  It was in less than 1% of the users and one foreign regulatory requested it not be pulled, but it was.

Working from home and usually have one of the news/business channels on.  You'd be surprised how many commercials there are for lawsuits for FDA approved drugs that later were found to have a side effect.

Am I correct in that in these cases the FDA isn't responsible even though they approved the drug for use?

[Labbug]

Once a drug started development, in my experience, one in eleven got to market.  Of the ten that do not get to market, you could spend tens of millions to half a billion dollars on them.  The sooner you kill a development drug the better.   One of our drugs that got to market, had to be pulled because it started showing severe side effects.  It was in less than 1% of the users and one foreign regulatory requested it not be pulled, but it was.

Working from home and usually have one of the news/business channels on.  You'd be surprised how many commercials there are for lawsuits for FDA approved drugs that later were found to have a side effect.


I'm I correct in that in these cases the FDA isn't responsible even though they approved the drug for use?


They are responsible for approval and are not libel for any of the adverse effects of the drug.  To give the FDA its due, they are in a rough position.  They are criticized both for the time it takes for approval and if they approve a drug that turns out to have problems.  One of the reasons side effects are not always seen, is the limited number of people in the clinical trials.  If my memory is correct, you have 15,000 to 20,000 people in all of the clinical trials before approval.  There is good chance you will not see some the side effects in the clinical trial population.  About 50% of the cost of development is in the clinical trials.  Also clinical trials usually continue after approval.

[Sir Slash]

As a nurse for 20+ years, I can tell you ALL drugs have side-effects and there is no such thing as a completely safe drug. Some side-effects can only be discovered by using the drug over a longer period of time than the drug trials the FDA uses. It's just the nature of medicine. It doesn't mean we should avoid new drugs nor should we sue over every new one either.

Depakote was a 'new drug' originally used for treatment of seizures. Only after using it for years was it discovered that it worked better than the drug of choice, Lithium, that was used for Bi-Polar Disorder. That turned out to be a very good thing as Lithium was a very dangerous drug to use. Depakote is now the drug of choice for Bi-Polar Disorder but only because it had a totally unforeseen effect.