WASHINGTON - In January 2015, five months before rival Teva Pharmaceuticals was supposed to come out with its own version of the EpiPen, drugmaker Mylan petitioned the Food and Drug Administration to block approval of the competitor's product.
Mylan had already managed to delay Teva's drug. In 2012, it filed a patent infringement lawsuit against Teva. As part of a settlement, Teva agreed not to launch its product for three years, until May 2015.
As that date neared for Teva to offer its emergency treatment for anaphylactic reactions, Mylan filed what’s known as a citizens petition with the FDA, arguing that Teva’s version wasn’t as effective as it should be.
It's unclear what impact Mylan’s petition had. It was rejected by the FDA. But the agency also denied approval of Teva’s product.
As Mylan CEO Heather Bresch appeared before a House committee Wednesday, amid public outrage over the skyrocketing cost of the company's EpiPens, the so-called citizens petitions were catching the attention of consumer groups and an expert in anti-trust law.
Manufacturers of brand-name drugs use the complex and time-consuming petitions, they say, to bog down or scuttle competitors' alternatives.
Maintaining a monopoly in the drug market is significant because manufacturers can spike prices if consumers have no choices. Mylan enjoys a near monopoly for devices that inject the drug epinephrine.
Even if the petitions do not ultimately scuttle the competition, a delay in processing time by the FDA can allow companies to hold onto a monopoly for months longer, making millions more dollars a day, said Michael Carrier, a Rutgers University law professor.
Mylan is now coming under fire for raising the price of a package of two life-saving EpiPens from $100 in 2007 to $600 this year.
Theoretically, consumer groups and others can use the citizens petitions to raise questions about a pending drug’s safety. But makers of brand-name drugs "seem to be abusing the process,” said Carrier, co-director of the Rutgers Institute for Information Policy and Law.
Despite their name, the citizens petitions are almost always filed by manufacturers of brand-name drugs to delay, if not block, generic competitors.
According to a recent study by Carrier, manufacturers of brand-name drugs were responsible for 108 of 124 citizens petitions -- or 92 percent -- filed with the FDA between 2011 and 2015.
In about two-thirds of the cases, petitions were filed within six months before a competing drug was supposed to win FDA approval.
Carrier questions whether the petitions raise serious issues, or are delaying tactics.
The FDA found merit in only 8 percent of the petitions, he noted.
The petitions have “avoided serious scrutiny,” he said in his report.
“In practice, they bear a dangerous potential to extend brand monopolies by delaying approval of generics, at a potential cost (to consumers) of millions of dollars per day," he wrote.
FDA Commissioner Dr. Robert Califf has also raised alarms about the practice.
In a July report to Congress, he wrote that the law "may not be discouraging the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues.”
Califf said the FDA is required by law to prioritize the petitions over other work -- including that dealing with “important public health concerns.”
Mylan spokeswoman Lauren Kashtan said in an e-mail that the company filed the petition because of concerns that Teva’s auto-injector could not be safely used by those who are not trained medical professionals.
The public petitions provide an “opportunity to voice an opinion by submitting comments, and puts the decision in FDA’s hands, where it belongs,” she said.
However, Consumers Union on Sept. 7 called on the Federal Trade Commission to investigate the Mylan citizens petition and the settlement.
“Mylan may have engaged in such anti-competitive conduct," its letter said.
Carrier said in his study that Mylan knew at the time of the 2012 settlement when Teva could go to market with its drug, if it got FDA approval.
Yet, Mylan waited until January 2015 to file its petition.
A month before Teva was to be able to offer its product, Mylan filed a 48-page study, he said.
“The late filing of supplemental information could well have been used to delay generic approval,” he wrote.
Teva spokeswoman Denise Bradley said only that the company is reviewing how to deal with the FDA’s complaints, and it does not plan to be able to offer its product this year.
Kery Murakami is the Washington, D.C. reporter for CNHI's newspapers and websites. Reach him at email@example.com.