Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic

Regulatory NewsRegulatory News
| 28 September 2016 | By Zachary Brennan 

Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market.


As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced in August that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-name product.

Though as Focus explained, the term “authorized generic” is a misnomer as it essentially means that Mylan will change the label of the branded EpiPen and charge less.

But before that shift, Mylan had negotiated a patent settlement with a potential EpiPen generic competitor from Teva, though the US Food and Drug Administration (FDA) in March rejected Teva’s generic version of the EpiPen and Mylan’s product remains the only EpiPen on the market (though as CDER Director Janet Woodcock noted last week, FDA has approved a total of four auto-injectors that dispense epinephrine – the active ingredient in the EpiPen, though none have caught on like Mylan’s EpiPen).

Murray Letter

Now, Murray is seeking more details on Mylan’s patent settlement with Teva, which remains confidential, though which she says, “publicly available information indicates that the agreement may resemble a ‘pay for delay’ agreement, which have been criticized by regulators and antitrust experts as constraining competition and raising drug prices.”

Murray also points to Mylan’s January 2015 citizen petition over the EpiPen, which was sent five months before the date Teva was permitted to launch a generic auto-injector under the agreement.

That petition questioned Teva’s design and operating principles of its proposed generic, saying it differs “significantly from those of the EpiPen auto-injector.”

At the heart of the petition is a claim from Mylan that “patients and caregivers will not be able to use the Teva product ‘in accordance with instructions provided for’ the EpiPen auto-injector because, among other things, the EpiPen auto-injector instructions expressly warn users not to touch the needle end of the device and the Teva product requires users to remove a safety cap covering the needle end of the device and flip a safety clip at the other end to be in a position to administer an injection.”

Murray also noted that the petition was followed in April 2015 by a supplemental analysis submitted by Mylan concluding that patients could not use the generic Teva device correctly.

The petitions were ultimately rejected by FDA, though Murray is still interested in obtaining by 7 October 2016: 

1. A copy of any and all agreements between Mylan, Meridian or its owners, and Teva regarding Teva's potential generic competitor, and all accompanying appendices, attachments or modifications to the agreement.

2. Any analysis in Mylan's possession, or funded or conducted by Mylan, that references Teva's generic epinephrine auto-injector.

3. A list of each EpiPen price increase undertaken by Mylan from 2009 to present that includes the date the decision was made to increase either the Wholesale Acquisition Cost (WAC) or the Average Net Price of the EpiPen and the date the price increase went into effect.

4. Any communications, including email communications, between April 2012 and present that references the current or future price of the EpiPen and also references Teva, including any mention of the status of filing, approval or any other regulatory development ofTeva's application for a generic epinephrine auto-injector.



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