What in the drug industry allows the price gouging?

[Ruken]

@lazybratsche

Thanks for digging into that. I was having a hard time figuring anything out myself…

Naiively I also assumed that Turing now owned some sort of drug production facility, rather than merely the marketing rights.

I can’t point you at a cite that says for sure one way or another for the current situation, so don’t thank too fast.

[lazybratsche]

Update:

The FDA will now give priority reviews for generic drugs whenever there’s a monopoly like we saw with Daraprim. That doesn’t remove barriers to competition entirely, but it does potentially remove years in the approval queue from the entire process. This change will also affect 125 pending approvals, which ideally will result in cheaper generics.

In the future, anyone attempting to repeat Shkreli’s price gouging will have a much smaller window of exclusivity. That doesn’t eliminate the opportunity for price gouging entirely, but with a greatly reduced incentive hopefully we won’t see anything quite so obscene.

The official policy for priority reviews is here, with the following paragraph added:

8. Submissions for “sole-source” drug products

Submissions for drug products for which there is only one approved drug product listed in the Prescription Drug Product List (the “active section”) of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) and for which there are no blocking patents or exclusivities may receive expedited review, except where the approved drug product was approved pursuant to a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act.

Clearly there’s still a lot that can and should be fixed with the FDA approval process, but this is definitely a step in the right direction.

[Ruken]

Thanks for the update; I hadn’t seen this. I agree it’s a positive move. We’ll see what the actual approval time ends up being.