A new 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 (SNY) 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 FDA wrote 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 a patent infringement lawsuit that was filed by a Pfizer (PFE) 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.