Court Sides with Vanda Against FDA in Freedom of Information Act Case

Pictured: Mihael Polymeropoulos, CEO, Vanda Pharmaceuticals/Company courtesy

Vanda Pharmaceuticals has prevailed in its case against the FDA. On Monday, a federal court sided in favor of Vanda in its Freedom of Information Act (FOIA) case against the agency regarding its sleep drug label expansion. 

In 2019, the biopharma received a complete response letter (CRL) from the FDA, rejecting its supplemental New Drug Application to add jet lag disorder as an indication for Hetlioz (tasimelteon). Now, the FDA must hand over documents and records related to the CRL.

Hetlioz is already approved for two sleep and circadian related disorders.

After the initial rejection, the company asked the FDA to share the reviews that led to the negative decision, Vanda CEO Mihael Polymeropoulos, M.D. told BioSpace.

“It’s only fair when you’re rejected to know why,” he said, after working for 14 years and spending billions. 

The FDA had invoked the deliberative process exemption under FOIA, claiming that it would suffer “foreseeable harm” by disclosing its reviews on Vanda’s sNDA.

Chris Howerton, a biotech analyst for Jefferies, told BioSpace in an email that the FDA disclosing procedures could potentially bias outcomes if drug developers were able “to play to nuances in specific processes for approval."

In court documents, the FDA asserted that disclosing clinical and statistical reviews prepared for the evaluation of a drug application would have "a chilling effect on staff communications."

The court rejected the claim and said in this particular case, “disclosure cannot chill” deliberations of agency staff.

After going through a number of dispute resolution and hearing applications, the team still does not know the justification for the rejection. The FDA did not grant a hearing, so in September 2022, Vanda sued the agency for access to the reviews.

“It seems that the FDA is comfortable to serve the justification of positive decisions, but not of negative,” Polymeropoulos said. “Sometimes, the most important public health decisions may be the drugs that the FDA did not approve.”

A timeline has not yet been ordered for Vanda to receive the information. Howerton said the agency may appeal the decision.

The FDA did not respond to BioSpace’s request for comment. 

Vanda wants the chance to recast the argument for the drug, Polymeropoulos said, and the team believed the initial submission to be a complete package with substantial evidence of efficacy for treating the symptoms of jet lag.

“The FDA has gutted the ability of innovators to ask for a hearing," he said. "Vanda’s approach will hold them accountable.”

Other Court Battles

Vanda has also been embroiled in patent battles over Hetlioz with the goal of keeping generics off the market. In December, the court invalidated four of the patents on Hetlioz, opening the door to generic competition from Teva, Apotex and possibly more.

A non-exclusive license deal struck in January 2022 with MSN Pharmaceuticals and Impax Laboratories kept a generic from hitting the market until mid-2035. However, the deal stipulates the companies can enter the market under the entry of certain other third-party generics.

Vanda is fighting the patent invalidation and expects a decision from the court of appeals in the next few months, Polymeropoulos said.

The first time the biopharma took the FDA to court over a partial clinical hold imposed on tradipitant, the court ruled in favor of the FDA. Vanda followed up on that loss by filing a lawsuit against the FDA for its rejection to grant tradipitant, an experimental treatment for gastroparesis, Fast Track designation. The lawsuit is currently pending.