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Submitted via IRC for Runaway1956
Update 5/17/2018: The FDA has now launched the website listing the names of brand name drugs and their makers who have stood in the way of generic drug companies trying to make more affordable alternatives. You can view the list here. It includes notable medications, such as Accutane (for acne), Methadone (used for opioid dependency), and Tracleer (to treat high blood pressure in the lungs). The brand name drug makers to be shamed includes big hitters such as Celgene Corp, GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, Gilead Sciences Inc, and Actelion Pharmaceuticals Ltd, now a Johnson & Johnson company. Our original story, published May 16, is unedited below.
The Food and Drug Administration plans this week to effectively begin publicly shaming brand-name drug companies that stand in the way of competitors trying to develop cheaper generic drugs.
FDA Commissioner Scott Gottlieb told reporters on Monday and Tuesday that the agency will unveil a website on Thursday, May 17 that names names of such companies. More specifically, the website will publicly reveal the identity of 50 branded drugs and their makers that have blocked generic development. The website will also be updated "on a continuous basis" to list additional names.
In fielding questions from reporters, Gottlieb denied that the effort was a form of public shaming. "I don't think this is publicly shaming," Gottlieb said, according to S&P Global Market Intelligence. "I think this is providing transparency in situations where we see certain obstacles to timely generic entry."
(Score: 2, Flamebait) by frojack on Sunday May 20 2018, @06:27AM (4 children)
I didn't find the story, or the methods convincing.
An FDA doctor writes a prescription, and a generic company obtains the samples from a retail pharmacy.
There are enough exemptions in the law to allow this without the manufacturer ever knowing about it once the patents expire.
I don't believe EITHER of the two tactics are actually any impediment to obtaining samples.
I have heard of some manufacturers coming out with new patented versions, sometimes with a simple change in a non-active ingrediant, sufficiently ahead of the old patent expiration so that all of the old product will be gone from the supply chain before the patent expires. Then they could refuse to restart the manufacturer of the old product to supply samples.
But seriously, obtaining samples isn't that hard.
No, you are mistaken. I've always had this sig.
(Score: 2) by Jiro on Sunday May 20 2018, @08:31AM (2 children)
I would be very surprised if the FDA permitted illegally-obtained samples to be used in testing. I would also be very surprised if a doctor who tried this didn't get reported to the medical board and punished, if the company ever finds out about it. (And I doubt the required number of samples is small enough that one physician could get them anyway.)
(Score: 1) by khallow on Sunday May 20 2018, @11:43AM (1 child)
Why would you use such samples in testing? Those are merely to determine what additives are included with the active ingredients.
(Score: 1) by khallow on Sunday May 20 2018, @12:54PM
(Score: 3, Informative) by Whoever on Sunday May 20 2018, @04:01PM
Once again, you are writing from the perspective of ignorance.
There is a good article on the topic here:
https://hbr.org/2017/04/how-pharma-companies-game-the-system-to-keep-drugs-expensive [hbr.org]
They also use captive pharmacies to limit supplies of their drugs to patients only (thus preventing equivalence testing).