U.S. Food and Drug Administration documents show Mylan, the much-criticized manufacturer of the EpiPen, filed an official petition with regulators against Teva Pharmaceutical Industries' application to sell a generic version of the allergy treatment.
Known as a citizen petition, the January 2015 document sent by Mylan (PDF) laid out the drugmaker's concerns with Teva's application, mainly focused on the differences in design between the branded product and generic. Mylan expressed concern those differences would prevent users trained on the EpiPen from being able to safely and effectively use Teva's product.
Mylan has been under fire from consumers and lawmakers who have expressed outrage at the $608 list price of its brand-name epinephrine auto-injector. The company said last week it would increase the value of its discount card and expand its patient assistance program, while conceding it hasn't done enough to help the growing number of consumers who have high-deductible health plans.
The concerns expressed in Mylan's petition shed light on the issues that Teva has had in gaining approval, which it had previously expected would be completed by summer 2015. Experts say these petitions can delay the approval process but don't often affect the FDA's final decision.
One of Mylan's biggest concerns was that Teva's product required the user to remove a safety cap from the needle end of the auto-injector and flip a safety clip at the other end. EpiPen instructions “expressly warn users not to touch the needle end of the device” because the branded device has a different mechanism to keep the needle from protruding. Mylan also noted that, while patients insert the EpiPen into their thigh in a stabbing-like motion, patients using the Teva device are instructed to hold the device against their thigh and then firmly push it down into the body, without the swinging motion.
In a supplement to the petition in April 2015, Mylan included the results of a contracted study that found 27 out of 30 study subjects failed to deliver simulated therapy using the Teva product because they were following the EpiPen instructions, which Mylan claimed don't work for the Teva product. Some experts have questioned the validity of that study, but the company has defended it.
Stewart Ehrreich, a regulatory consultant and former FDA official, said citizen petitions against generic drug applications are a drain on the approval process and don't often have a significant impact on whether an application is approved or rejected.
“They're sort of a last ditch effort to try to get something done in a bureaucracy that doesn't want to do anything,” Ehrreich said.
Ehrreich, who has also worked for several drugmakers, said citizen petitions are rarely a barrier to approval, are held in “low esteem” by regulators and aren't high on the priority of officials among the many drug applications they must also review.
“Some petitions can make a dent,” he said. “Citizen petitions eventually can be very important, but usually they're not.”
The FDA must answer petitions within 150 days, and the drug approval process can't be completed until all petitions are given a response, so they can slow the drug process down even though they're not often acted upon, said Michael Carrier, a law professor at Rutgers University. He conducted a study that found 92% of so-called 505(q) petitions are made by brand-name drugmakers, and the FDA has only taken regulatory action on 8% of petitions, declining the remainder.
That suggests drugmakers may be tying up the approval process even though it's unlikely anything will come of their efforts. In fact, the study, released this week, mentions Mylan's late filing of a petition supplement against Teva as a possible tactic to delay generic approval.
“It's concerning that brands are filing just about all of them, which is not consistent with the whole nature of a citizen petition,” Carrier said.
Being more transparent about the amount and sources of the petitions could help draw attention to the problem, Carrier said. The FDA also could use its power to immediately deny petitions that delay generic approval and ostensibly don't raise valid scientific or regulatory concerns, a power it has never invoked, according to the study.
“It's worse than busy work,” Carrier said. “It's something that diverts resources that should go for more important purposes."
