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Scams And Monopolies: How Mylan tried to keep Teva from selling a generic EpiPen

Posted by on Sep. 7, 2016 at 8:41 AM
  • 6 Replies

Anew study finds that citizens’ petitions can “play a crucial role in delaying” generic drugs from becoming available — and cites Mylan Pharmaceuticals as a prominent example of companies whose reliance on such tactics is questionable.

In particular, the study points to a petition that Mylan filed in early 2015 in an attempt to persuade the US Food and Drug Administration not to approve a rival to its EpiPen device for life-threatening allergic reactions, which was being developed by Teva Pharmaceuticals.

The study arrives amid intense controversy over EpiPen pricing and the extent to which Mylan has exploited its near-monopoly on the market. Since buying EpiPen a decade ago, Mylan has raised the price 548 percent – to $600 – but has faced little competition.

A rival device from Sanofi was recalled last year due to dosage problems and the FDA rejected Teva’s auto-injector earlier this year. The only competing device, called Adrenaclick, has sold poorly, largely because Mylan has dominated the market and many people are unfamiliar with the way Adrenaclick works. In fact, Mylan has about an 89 percent market share currently, according to Truven Health Data.

What Mylan did is “concerning because they used a petition to delay generic entry,” said Michael Carrier, a Rutgers University School of Law professor and coauthor of the study, which is being published in the American University Law Review.

The analysis found, in fact, that brand-name drug makers filed 92 percent of citizen petitions between 2011 and 2015, although the US Food and Drug Administration denied more than 9 out of every 10 petitions. Last week, the FDAwrote Congress that most petitions do not raise valid scientific concerns and appear to have been filed to delay approval of competing medicines.

The study authors explained that Mylan was aware that Teva would look to sell a generic version of EpiPen by July 2015. That’s because, in 2012, Teva settled apatent infringement lawsuit that was filed by a Pfizer unit that made EpiPen for Mylan. As part of the deal, Teva was allowed to sell a generic by mid-2015, or possibly earlier.

So Mylan responded by filing a citizen’s petition with the FDA in January 2015, and urged the agency not to approve the Teva product unless it was the same as EpiPen. A key part of the Mylan argument was that anything other than an identical product may make it difficult for patients in an emergency situation to use a generic safely and effectively in keeping with instructions for EpiPen.

The FDA had 150 days to respond to Mylan’s petition, and that deadline coincided with the time when the patent settlement allowed Teva to begin selling a generic. But in May 2015, Mylan supplemented its petition with a report from a consulting firm that gave the generic device to patients and concluded they were not using the Teva product correctly and, therefore, it would not be effective.

However, the analysis “had a lot of problems,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank. The analysis lacked a control group; did not study the actual generic but a prototype instead; used a small number of participants; failed to provide them with proper instructions for use; and told participants to watch a video rather than actually use the Teva device.

A Mylan spokeswoman wrote us that the study “applied the fundamentals of human factor engineering and analysis to examine the proposed Teva product against FDA’s standards for approving a generic product like this.  The question FDA asks is whether, in an emergency, a patient or caregiver who is trained on the EpiPen could, without training on the proposed generic, successfully use the generic product in accordance with the EpiPen directions for use. Given the purpose of the study, we believe its design and implementation offered a valid examination of the human factor issues presented by Teva’s distinct design and operating steps.”

We asked Interface Analysis, the consulting firm, for comment and will update you accordingly.

The petition also included a statement from Dr. Eli Meltzer, an allergist in San Diego, who declared that “I do not believe that a user trained on the EpiPen … platform will be able to reliably use a different operational platform in an emergency situation as safely and effectively.” As noted by NBC News, which first reported about the citizen petition and the study, Meltzer was paid roughly $95,000 in fees in 2014 and 2015 by Mylan, according to the OpenPayments federal database.

By filing the supplement, Mylan presumably hoped to further extend the time the FDA would need to review its entire petition. But the FDA denied the petition in June 2015, anyway. Ultimately, the FDA rejected the Teva product last February due to unspecified deficiencies. Carrier speculated that Teva may have been able to fix those problems if the patent lawsuit had not delayed its ability to enter the market.

by on Sep. 7, 2016 at 8:41 AM
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4ofSpades
by on Sep. 7, 2016 at 8:42 AM
Published on
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http://www.commondreams.org/news/2016/09/06/ny-ag-launches-probe-whether-epipen-maker-scammed-schools

NY AG Launches Probe Into Whether EpiPen Maker Scammed Schools

After price gouging scandal, Mylan now faces accusations of violating anti-trust laws

 "No child's life should be put at risk because a parent, school, or healthcare provider cannot afford a simple, life-saving device because of a drug-maker’s anti-competitive practices," said New York attorney general Eric Schneiderman. (Photo: Kira Stewart-Watkins/cc/flickr)

"No child's life should be put at risk because a parent, school, or healthcare provider cannot afford a simple, life-saving device because of a drug-maker’s anti-competitive practices," said New York attorney general Eric Schneiderman. (Photo: Kira Stewart-Watkins/cc/flickr)

After stirring national outrage over its alleged price gouging of emergency allergy drug EpiPen, pharmaceutical giant Mylan is under fire once again for potentially violating anti-trust laws by inserting "potentially anticompetitive terms" into its EpiPen sales contracts to schools.

In a statement announcing the launch of a new investigation Tuesday, New York Attorney General Eric Schneiderman declared: "No child's life should be put at risk because a parent, school, or healthcare provider cannot afford a simple, life-saving device because of a drug-maker’s anti-competitive practices."

Vowing to "bring the full resources of my office to this critical investigation," Schneiderman continued, "If Mylan engaged in anti-competitive business practices, or violated antitrust laws with the intent and effect of limiting lower cost competition, we will hold them accountable...Allergy sufferers have enough concerns to worry about—the availability of life-saving medical treatment should not be one of them."

A preliminary probe by the office of the New York AG reportedly found evidence suggesting that Mylan may have "locked schools into non-competitive contracts in order to purchase the EpiPens at an affordable price," according to Bloomberg, citing an undisclosed person familiar with the matter.

Echoing those concerns, Sens. Richard Blumenthal (D-Conn.) and Amy Klobuchar (D-Minn.) on Tuesday sent a letter to the Federal Trade Commission (FTC) calling on the agency "to issue Mylan an administrative subpoena to determine whether the company deliberately engaged in exclusionary practices to hinder its competitors and maintain its monopoly position in the market," The Hill reports.

The lawmakers cited a document that appeared to confirm allegations of the illegal contracts, which they said could be in violation of Section 5 of the Federal Trade Commission Act, which prohibits unfair methods of competition.

"The FTC must investigate whether Mylan has maintained its monopoly position through the use of these exclusive supply contracts, enabling the company to engage in price gouging for EpiPens by blocking rivals from becoming effective competitors," the letter stated.

The embattled drug-maker is already the subject of national scorn after it was revealed to have increased the price of the life-saving drug 400 percent since 2009, while at the same time rewarding company executives with exorbitant bonuses.

Attempts by the drugmaker to remedy the scandal, through the creation of discount programs and a generic alternative, were blasted last week by a group of 20 lawmakers, including progressive darlings Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), as industry "shell games."

4ofSpades
by on Sep. 7, 2016 at 8:44 AM

I agree that people who deliver and use a different injector should know how to use it, but can't they learn? The fact that epipen corners the market and has patents protecting its use and directions shouldn't be enough to keep a generic with a different delivery system off the market.

Bookwormy
by Ruby Member on Sep. 7, 2016 at 8:53 AM
This depresses me so much. My school district does not carry stock epipens in their schools, tho I think it should.
4ofSpades
by on Sep. 7, 2016 at 1:21 PM

I appreciate that the company would sell the pen at a discount price to schools. I would expect the costs to be different, or less, at schools and county clinics. I don't necessarily understand why it's important that the costs to the general public being dispensed from a pharmacy is critical to the cost associated with other places they're needed like free or reduced fee clinics and schools.

I don't understand formulary guidelines at all.

Quoting Bookwormy: This depresses me so much. My school district does not carry stock epipens in their schools, tho I think it should.


Bookwormy
by Ruby Member on Sep. 7, 2016 at 1:28 PM
1 mom liked this
Adrenaclick has a generic and folks certainly can learn how to use it! Problem is that it just isn't as common. People don't learn how to use it, but they certainly can.

Quoting 4ofSpades:

I agree that people who deliver and use a different injector should know how to use it, but can't they learn? The fact that epipen corners the market and has patents protecting its use and directions shouldn't be enough to keep a generic with a different delivery system off the market.

Peggysueplus2
by on Sep. 7, 2016 at 1:33 PM
1 mom liked this
It doesn't, you are correct. Epinephrine is dirt cheap. The only thing that makes epi pen special is the injector. Use a different delivery.

The upcoming products are smaller and cheaper. In the meantime, use adrenaclick or old fashioned syringes.

Quoting 4ofSpades:

I agree that people who deliver and use a different injector should know how to use it, but can't they learn? The fact that epipen corners the market and has patents protecting its use and directions shouldn't be enough to keep a generic with a different delivery system off the market.

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