Reference Listed Drug (RLD) Access Inquiries

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm607738.htm

by aaavl2821 • 8 years ago

39 20 8 years ago

fda.gov

chipperyman573• 8 years ago

Instead of just naming the bad actors, what stops the FDA from taking action against them? If there's no generic available for a pill, pharma companies won't care about bad PR - people have no choice but to buy their product.

JumpCrisscross2• 8 years ago

what stops the FDA from taking action against them?

What law are they breaking?

maxander2• 8 years ago

Doesn’t need to be legal enforcement. The FDA could simply start taking its time when issuing new drug approvals, study registration, etc, for bad actors. A substantial quantity of a pharmacy company’s budget and product development cycle is devoted to dealing with the FDA as it is, making it any worse would be a big deal.

aaavl28213• 8 years ago

It isn't clear what FDA could actually do in these cases. The companies are basically choosing how to distribute their product, and some pick distributors that make it hard for researchers to access the product

I actually started a company a few years back trying to make a generic version of one of these drugs and we found that there are all kinds of FDA-related issues beyond just access to RLDs -- it is a very murky and complex area of drug dev

refurb3• 8 years ago

It isn't clear what FDA could actually do in these cases

What most of the companies are doing, at the least the ones with "YES" in the "Does the product have a REMS with ETASU Impacting Distribution?" column is conveniently interpreting the law to block generics.

ETASU is "Elements to assure safe use". It's a part of the FDA's REMS (Risk evaluation and mitigation strategy). Certain drug have safety risks where the FDA has asked manufacturers to go above and beyond making it "prescription only".

REMS can include additional documentation and certification so that doctors prove they understand the risks. It can also include additional documentation for patients. The most strict REMS forces companies to restrict access by limiting the number of pharmacies who can dispense the product and blocking prescriptions where the terms of the REMs haven't been met.

It's that last part where the companies are taking a self-serving view of the law. Normally generic companies can request a sample of a branded product (to develop a generic) and the branded company must provide it. With these drugs, the branded company says "but there is no patient! They haven't filled out the forms! We'll get in trouble with the FDA if we do it!"

As a result, the FDA has come out a number of times and said "No, providing a sample to a generic company is not a violation of the REMS regulations."

This is an attempt to shame the companies into providing samples.

The most direct way to fix this is for Congress to tweak the generic drug laws and make it clear not providing a sample, even for REMS drugs is a violation and they can be penalized.

trumped2• 8 years ago

4 of the drugs listed are fentanyl... would preventing generics help reduce the abuse of this deadly drug?

mv2• 8 years ago

It is deadly as a street drug, but it is safe and effective in the hospital setting.

It is used on nearly every patient that has an operation with anesthesia and would be very difficult to find a replacement that is as versatile.

propman• 8 years ago

That is a blankety false statement mate. It's not used on nearly every patent, it's VERY rarely used for anesthesia. Very rarely.

trumped2• 8 years ago

do hospitals even use generics? (but I was not talking about hospital use in my previous comment)

One reason why it is deadly in the streets is because a safe dose is so small and hard to measure: http://mediad.publicbroadcasting.net/p/wosu2/files/styles/x_...

dominotw• 8 years ago

correct me if I am wrong this is list of companies requesting access to samples not the ones blocking development of generics.

maxander2• 8 years ago

No. Read the text- it’s companies that are refusing to provide samples of their own drugs to generic manufacturers, thus blocking the development of said generic versions.

billysielu• 8 years ago

This list seems short. It should include anyone with a patent.

AceJohnny2• 8 years ago

Oh hey, funny seeing Valeant in there. I'm actually a bit disappointed to see them only once, with more references to the usual Big Names (Novartis, Bayer, GlaxoSmithKline...).

For some insight into the business of pharma, may I humbly recommend Derek Lowe's amazing blog In The Pipeline. For example, here's the most recent article of his about Valeant I could find, from last year:

http://blogs.sciencemag.org/pipeline/archives/2017/04/03/bil...

I first discovered his blog through his series "Things I won't work with", with some hilarious descriptions of very very dangerous chemicals:

http://blogs.sciencemag.org/pipeline/archives/category/thing...

aaavl28213• 8 years ago

Derek's blog is great. I also recommend Bruce Booth's lifescivc blog, which is one of the few blogs written by top tier early stage biotech VCs

https://lifescivc.com/

Reference Listed Drug (RLD) Access Inquiries

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