Intarcia’s Request to Alter AdComm Procedures for Diabetes Treatment Denied

The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the agency grant other requests Intarcia made last month.

Responding to Intarcia’s May 18 letter containing several requests and complaints, CDER, which has jurisdiction over the combination product, said in a June 2 letter to the company’s lawyer that it will follow the same procedures for the EMDAC meeting as it would for any other drug product.

CDER took a hard line on Intarcia’s request to hand pick ad hoc reviewers for the July meeting, saying “CDER declines to solicit input from Intarcia regarding selection of ad hoc members,” the agency wrote.

The center also shot down a request for “at least several hours” to make the company’s presentation, telling Intarcia that the time given to a sponsor presentation to a CDER advisory committee convened under Title 21 Part 14 is 60 to 90 minutes. The center decided to split the 90-minute allotment between Intarcia’s and CDER’s own presentation.

CDER added that Intarcia can include any extra information that doesn’t fit into that time frame in its briefing materials for committee members to review.

Read CDER’s letter to Intarcia here. — Suz Redfearn

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