
Reference Listed Drug (RLD) Access Inquiries - aaavl2821
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm607738.htm
======
AceJohnny2
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...](http://blogs.sciencemag.org/pipeline/archives/2017/04/03/bill-
ackman-pompey-and-you)

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...](http://blogs.sciencemag.org/pipeline/archives/category/things-
i-wont-work-with)

~~~
aaavl2821
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/](https://lifescivc.com/)

------
chipperyman573
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.

~~~
aaavl2821
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

~~~
refurb
_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.

~~~
aaavl2821
I agree, in the case where there is a REMS, FDA can't do anything, and in the
case where there isn't, FDA can do even less.

Agreed that a legislative fix seems reasonable. That would actually be a
pretty straightforward way to reduce drug prices at least for a subset of
drugs. However as weve seen with recent action / inaction on drug pricing,
public and bipartisan support of drug price controls + heavy pharma lobbying =
watered down legislation / lots of talk and little action

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

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

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

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

~~~
mv
I am a board certified anesthesiologist in the USA. What is your justification
or source for calling this false?

Fentanyl is given to nearly every patient prior to intubation and frequently
redosed throughout most operations.

~~~
refurb
Once again, the hubris of HN users comes back to bite them!

