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A recall for EpiPens will now extend to Asia, Europe, North America, and South America:
Generic drugmaker Mylan NV said on Friday that its manufacturing partner for EpiPen devices had expanded a recall of the life-saving allergy shot in the United States and other markets.
The announcement comes a week after Mylan said it had recalled about 81,000 EpiPen devices in countries outside the United States following two reports of the company's allergy treatment failing to work in emergencies.
[Ed. Note: This recall is limited to some lot numbers distributed in late 2015 and early-to-mid 2016. More information at the US FDA website.]
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For recreational use only.
(Score: 5, Informative) by stormwyrm on Monday April 03 2017, @07:49AM (5 children)
As I pointed out previously [soylentnews.org], the original EpiPen design dates from the 1970s and the design was FDA-approved in 1987. The patent for that version of the EpiPen should have expired in 2007 at the latest, leaving a generics manufacturer or other competitor able to develop an EpiPen using the original designs by Sheldon Kaplan and Survival Technology (which company was the subject of a string of mergers and acquisitions that eventually ended at Mylan). Mylan obviously can’t sue someone for implementing the designs described by an expired patent, even if they were its original inventors, and a manufacturer would have to follow the patent, or else they’d have to seek FDA approval for any changes they might have made. A lot of money could be made by someone who tried to do this: apparently the manufacturing cost for such a device is in the $30 range, so even at a tenth of what Mylan wants for its EpiPens, you have a profit margin of $30, which could translate to hundreds of millions of dollars in profit given the kind of market the device has. Mylan would be unable to price gouge the way they do if such a thing existed. This is exactly how the patent system was intended to function when it was first envisioned! So why is no one making EpiPens using the now public domain 1987 design? Something is very wrong with this picture.
Numquam ponenda est pluralitas sine necessitate.
(Score: 0) by Anonymous Coward on Monday April 03 2017, @02:35PM (4 children)
Why no competitor? Small, limited market, and Mylan may implicitly threaten to price any new competitor out so it's not terribly tempting for new comers to come in.
(Score: 0) by Anonymous Coward on Monday April 03 2017, @03:25PM (3 children)
(Score: 2) by bob_super on Monday April 03 2017, @05:13PM
> run afoul of antitrust law as a result
Quake in your boots! A couple blue state AGs may start hinting at a decades-long process which might potentially result in a minor slap on the wrist!
(Score: 0) by Anonymous Coward on Monday April 03 2017, @05:46PM (1 child)
Being a monopoly is not a criminal offense, collusion/market power abuse is.
(Score: 0) by Anonymous Coward on Tuesday April 04 2017, @01:23AM
No, monopolies aren’t illegal. But if you’re a monopoly and use that position to try to shut potential competitors out of the market, that is market power abuse. One example of market power abuse is by attempting to price competitors out of the market, as the GGP says Mylan could potentially do to other pharmaceutical companies trying to market the old EpiPen design.