Allergy News: EpiPen Class Action Can Proceed; DBV Hopeful on Patch

in Food Allergy, Food Allergy News, Peanut & Tree Nut
Published: January 19, 2021
Lawyer holding the hammer and the judge read the verdict.
Photo: Getty

Mylan Loses Bid to Dismiss Lawsuit

A U.S. district judge has ruled that a class action lawsuit against Mylan Inc., the marketer of the EpiPen auto-injector, and a group of pharmacy benefit managers (PBMs) can proceed.

Mylan, now part of Viatris Inc., and the PBMs lost in a bid to have the Minnesota-based class action dismissed. The suit, brought by drug distributors, alleges that the Mylan and the PBMs conspired to engage in anticompetitive practices that drove up the price of EpiPens for mutual benefit.

Mylan has faced pricing controversy since it surfaced that the list price for a set of two branded EpiPens rose rapidly to $600 in 2016, an increase of more than 500 percent from 2008.

PBMs usually negotiate favorable prices for their insurer clients, but the lawsuit alleges that instead the defendant PBMs accepted large rebates – described as kickbacks – from Mylan. In return, the suit contends the PBMs gave highly preferential treatment to EpiPen versus new auto-injector competitors (Auvi-Q and the generic version of Adrenaclick), which were either kept off insurer formulary lists or put in less favorable formulary tiers.

The PBMs and Mylan each argued separately that they did nothing outside of normal commercial business, and that the plaintiffs failed to make the case that they had violated the Racketeer Influenced and Corrupt Organizations Act (RICO) or, in Mylan’s case, also the Sherman Act. (The latter relates to unlawful behavior to maintain a monopoly.)

However, U.S. District Judge Eric Tostrud in Minnesota ruled that the “plaintiffs have stated plausible claims under RICO and the Sherman Act.” While Mylan and the PBMs contended they were pursuing their own “divergent goals” as businesses, Tostrud found that “the Complaint contains a fairly clear description of why Mylan and the PBM Defendants all had interests in keeping EpiPen prices inflated.”

Mylan argued as well that the plaintiffs’ claims exceeded a four-year statute of limitations, but Tostrud said dismissal on that basis would be “inappropriate” at this stage of legal proceedings.

Mylan also faces a number of other class action lawsuits related to EpiPen pricing practices.

DBV Buoyed By Skin Patch Feedback

Photo: DBV Technologies

In August 2020,  the U.S. Food and Drug Administration said it would not approve DBV Technologies Viaskin Peanut patch therapy, at least not in its present form.

The FDA called for a “new human factors study,” for the novel allergy desensitization treatment, and raised concern about the daily-use patches adhering properly to patients’ skin.

DBV, which completed Phase 3 clinical trials for Viaskin Peanut, vowed to move forward to make any necessary changes to achieve biologic license approval. On Jan. 14, the  biopharmaceutical company announced that it was encouraged by written feedback from the agency, saying “the FDA provides a well-defined regulatory path forward.”

Specifically, DBV says:
• The FDA agreed that a modified Viaskin Peanut patch would not need to start from square one, and be considered a new product. That’s the case as long as the skin patch chamber and the level of exposure – 250 micrograms of peanut protein – through the skin remain the same.

• The FDA has suggested a six-month clinical trial to confirm consistency of safety and effectiveness data between the existing and modified patches in the target audience of peanut-allergic children (aged 4 to 11).

DBV CEO Daniel Tassé said he was “encouraged by the positive feedback” from the FDA, and that his team is working on modified patches. DBV hopes to have a trial protocol ready for FDA review by the second quarter of 2021.

To preserve cash flow, the company has initiated a global restructuring and cost-cutting plan.

See Also:
FAQ on: Allergy Concerns and mRNA COVID-19 Vaccines
Peanut Patch Benefits Improved with 3 Years of Therapy