2aguy
Diamond Member
- Jul 19, 2014
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And here we have a look at why you have an Epi pen crisis....and the FDA, the government is right there causing it....
Blog: Why Mylan Labs is being scapegoated by the Political class
The answers can be divided into regulatory overreach, market demand created by the regulators and the opaque nature of pricing within the drug distribution channels
In 2015, The FDA made a series of decisions that effectively led to limited options for patients needing epinephrine and created a virtual monopoly for Mylan Labs.
This was accomplished by stiff-arming Adamis Corporation’s pre- filled epinephrine syringe, asking for more data and demanding an expanded patient usability study including product stress testing before the original application.
Back in November 2015, France based Sanofi Corporation’s Auvi-Q product hit a wall, when an injector fault triggered a hefty recall.
Ultimately, the pharmaceutical giant yanked Auvi-Q from the market, More recently, the FDA handed generics giant Teva Pharmaceutical a rejection for its generic version of EpiPen, flagging “certain major deficiencies” in its letter to the Israeli pharmaceutical corporation. With serious issues to work through, Teva said earlier this year that it expects its product to be "significantly delayed" -- meaning it doesn’t expect a rollout before 2017.
Read more: Blog: Why Mylan Labs is being scapegoated by the Political class
Follow us: @AmericanThinker on Twitter | AmericanThinker on Facebook
Blog: Why Mylan Labs is being scapegoated by the Political class
The answers can be divided into regulatory overreach, market demand created by the regulators and the opaque nature of pricing within the drug distribution channels
In 2015, The FDA made a series of decisions that effectively led to limited options for patients needing epinephrine and created a virtual monopoly for Mylan Labs.
This was accomplished by stiff-arming Adamis Corporation’s pre- filled epinephrine syringe, asking for more data and demanding an expanded patient usability study including product stress testing before the original application.
Back in November 2015, France based Sanofi Corporation’s Auvi-Q product hit a wall, when an injector fault triggered a hefty recall.
Ultimately, the pharmaceutical giant yanked Auvi-Q from the market, More recently, the FDA handed generics giant Teva Pharmaceutical a rejection for its generic version of EpiPen, flagging “certain major deficiencies” in its letter to the Israeli pharmaceutical corporation. With serious issues to work through, Teva said earlier this year that it expects its product to be "significantly delayed" -- meaning it doesn’t expect a rollout before 2017.
Read more: Blog: Why Mylan Labs is being scapegoated by the Political class
Follow us: @AmericanThinker on Twitter | AmericanThinker on Facebook