Drugs

Ignore Former FDAer’s Comments: Sidley

Responding to a comment submitted by former FDA Office of Orphan Product Development director Timothy Cote on a Sidley 11/2/2023 petition submitted on behalf of a client involving orphan drug exclusivity (ODE) for an investigational oral vigabatrin solution, Sidley says Cote’s arguments “are frivolous and should be disregarded.” The original Sidley petition asked that FDA not grant orphan drug exclusivity to Pyros Pharmaceuticals’ PYR-003. The petition said that oral vigabatrin solution has been approved in the U.S. as a treatment for infantile spasms since 2009 and thus is an established, multisource product category.

“The only way for Pyros to earn orphan drug exclusivity is to demonstrate that its proposed formulation will be clinically superior to all other vigabatrin solutions,” Sidley said. “All publicly available information indicates that Pyros cannot make that demonstration.”

According to the Sidley response, Cote argued that:

citizen petitions should not be used to address ODE determinations;
the clinical superiority of the Pyros product is “easy to see,” “self-evident,” and an “exemplary case”; and
granting the petition would block access to the Pyros product.

In its response, Sidley makes these points:

FDA has repeatedly recognized that citizen petitions are the preferred way for stakeholders to engage with the agency on ODE questions;
asserting that clinical superiority is self-evident reflects a fundamental misunderstanding of the law; and
the petition does not seek to block or delay approval of the Pyros product but only to deny it ODE.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome