The CEO of Mylan Pharmaceuticals announced the launch of its own cheaper version of the EpiPen this week on the heels of a price hike uproar. But for years, Mylan and its business partners have fought fiercely behind the scenes to block a cheaper generic from hitting the market, the I-Team has learned.
Documents reviewed by the I-Team show the Pennsylvania-based drug firm paid for opposition research on a generic EpiPen proposed by Teva, an Israeli pharmaceutical company.
The study concluded the Teva product would have a 93 percent failure rate.
But experts on research methodology say the study has significant flaws, including the lack of any control group, the lack of any statistical significance, and the fact that study participants were instructed “not to actually manipulate the device or perform the injection.”
“The study was just flawed from start to finish,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit that monitors Food and Drug Administration regulatory policy. […]
That study, part of a submission to the FDA called a Citizen Petition, was just one flank in a strategy aimed at blocking the cheaper Teva generic. […]
Citizen Petition, including opposition research, routinely delay FDA decision-making because the agency is required to review the material, no matter how scientifically sound. In some cases, health regulators take weeks, months or even years to respond to Citizen Petitions.
Michael Carrier, a Rutgers law professor who reviewed 15 years’ worth of Citizen Petitions, found only a small minority of the filings actually come from individual citizens. Instead, he found more than two thirds come from brand name companies and most of those petitions seek to block cheaper generics from hitting the market.
“It’s really about the brand company delaying the generic from entering the market,” Carrier said. “Because every day that they can delay generic entry could be millions of dollars lining its pockets.” […]
Meanwhile, Mylan has announced its own generic EpiPen will be out in a few weeks and priced around $300. But the company will continue to enjoy a monopoly, also selling the brand-name version for about $600.
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