A new study considers the requests of citizens can “play a crucial role in delay “generic drugs that are available -. and cites Mylan Pharmaceuticals as a prominent companies such whose dependence on such tactics is questionable
in particular, the study suggests a request that Mylan introduced in early 2015, in an attempt to persuade the Food and Drug Administration US not to approve a rival to his EpiPen device for life-threatening allergic reactions, which was being developed by Teva Pharmaceuticals.
The study comes amid intense controversy over EpiPen prices and the extent to which Mylan has exploited its near monopoly in the market. Since purchasing EpiPen a decade ago, Mylan has raised the price of 548 percent – $ 600 -., But it has faced little competition
A rival Sanofi device was recalled last year due to dosing problems and the FDA rejected Teva autoinjector earlier this year. The device only compete, called Adrenaclick, it has sold poorly, largely because Mylan has dominated the market and many people are unfamiliar with how it works Adrenaclick. Indeed, Mylan has a market share of about 89 percent now, according Truven Health Data.
the Mylan did is “relative, because they use a request to delay the marketing of generic drugs,” said Michael Carrier, a professor at the Faculty of law and co-author of the study, published in the University of law of American opinion Rutgers University.
The analysis found, in fact, that brand drug manufacturers submitted 92 percent of the requests of citizens between 2011 and 2015, although the Administration Food and Drug US declined more than 9 10 requests. Last week, the FDA wrote Congress that most requests pose no valid scientific problems and seems to have been presented to delay drug approvals competition.
The study authors explained that Mylan was aware that Teva would look to sell a generic version of EpiPen for July 2015. That is because, in 2012, Teva has installed a demand patent violation which was presented by a Pfizer unit that made EpiPen for Mylan. As part of the agreement, Teva was allowed to sell to a generic mid-2015, or possibly earlier.
Thus Mylan responded by submitting a request by a citizen with the FDA in January 2015, and urged the agency not to approve the Teva product unless it were the same as EpiPen. A key part of the argument was that Mylan anything other than an identical product can make it difficult for patients in an emergency situation to use a generic safely and effectively in accordance with the instructions for EpiPen.
The FDA had 150 days to respond to the request of Mylan, which coincided with the deadline of when the patent agreement allowed Teva start selling a generic. But in May 2015, Mylan supplemented its request with a report a consulting firm that gave the generic device for patients and concluded that they were not using the Teva product correctly and, therefore, would not be effective.
However, the analysis “had a lot of problems,” said Diana Zuckerman, who heads the National Center for Health Research, a research center nonprofit. The analysis did not have a control group; not study the actual generic, but instead of a prototype; used a small number of participants; failed to provide adequate instructions for use; and he told participants to watch a video instead of actually using the device Teva.
A spokeswoman for Mylan wrote that the study “apply the principles of human factor engineering and analysis to examine the Teva proposed product meet the FDA standards for approval of a generic product like this. The question concerns the FDA is whether, in an emergency, a patient or caregiver who is trained in the EpiPen could, untrained in the generic proposal, properly use the generic product, according to the instructions for use EpiPen. given the purpose of the study, we believe that their design and implementation offered a valid consideration of human factors presented by designing and operating various stages of Teva. “
Ordered Analysis interface, the consulting firm, for comment and will be updated accordingly.
the petition also included a statement by Dr. Eli Meltzer, an allergist in San Diego, who declared that “I do not think that a trained user … platform will EpiPen able to reliably use a different operating platform in an emergency situation as safe and effective. “as noted by NBC News, which first reported on the request of citizens and study, Meltzer was paid approximately $ 95,000 shares in 2014 and 2015 by Mylan, according to OpenPayments federal database.
Introducing the supplement, presumably Mylan hopes to further expand the time the FDA would have to review all of your request. However, the FDA rejected the request in June 2015, anyway. Ultimately, the FDA rejected the product Teva last February due to deficiencies unspecified. Carrier speculates that Teva may have been able to solve these problems if the patent lawsuit had not delayed their ability to enter the market.