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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: 1, Informative) by Anonymous Coward on Sunday May 20 2018, @04:12AM (2 children)
https://en.wikipedia.org/wiki/Generic_drug [wikipedia.org]
Basically, you need to prove your generic is the same as the Branded product, and you can only do that using comparisons. You also need to have chain of custody type documentation, so if the branded product manufacturer refuses to sell to you, and puts in their contracts that no one else can sell to you, it is very difficult to prove that your drug is the same as theirs. Just buying some off the street isn't good enough.
(Score: 2) by frojack on Sunday May 20 2018, @06:33AM (1 child)
Change the rules so that the generics need only adhear to the publised patent description, and let the original manufacturer explain why their submitted patent documents were erroneous for 17 to 20 years.
Put the risk on them.
No, you are mistaken. I've always had this sig.
(Score: 3, Insightful) by deimtee on Sunday May 20 2018, @09:13PM
The patented chemical is not the same thing as the FDA approved drug, and leaving something out of the patent description isn't illegal anyway.
So what happens when one of the unmentioned ingredients in the pill is something that mitigates one of the side effects of the patented drug?
Eg. an anticoagulent in something that would otherwise cause clots? The branded medicine works as claimed, people who take the generic have heart attacks and strokes.
Who is responsible? The branded company is certainly going to deny it, and legally they are probably right.
If you cough while drinking cheap red wine it really cleans out your sinuses.