Report: Theranos case overburdening the FDA

Tuesday, January 14, 2020

Source: MassDevice

Preparations for the criminal trial of former Theranos executives is straining the FDA’s staff and diverting them from other duties, a lawyer for the agency told a federal judge this week, according to published reports.

FDA chief counsel Stacy Amin also told Judge Edward Davila of U.S. District Court for Northern California that technological problems could force the agency to even miss an extended deadline for filing internal documents demanded by lawyers for ex-Theranos executives, according to a report by Law.com.

The U.S. Securities and Exchange Commission charged discredited Theranos founder Elizabeth Holmes and former company president Ramesh “Sunny” Balwani with fraud in May 2018 for allegedly exaggerating or making false statements about the company’s blood-testing technology, business and financial performance after raising more than $700 million from investors.

Prosecutors missed a Dec. 31, 2019 court-ordered deadline to produce those documents because of what Amin called the “wholly unprecedented” requirements of the court order, and have asked for a new deadline of April 30. This was the third missed deadline, and Davila has not ruled on the request for another extension.

Amin said the agency had archived some internal emails and separated their attachments, making it difficult to search on specific terms, according to the Law.com report. Staff and resources that the agency would normally use to prepare its criminal case have been reassigned to fulfill the defense’s demands, she added.

The trial is scheduled to begin Aug. 4. The next hearing in the case is set for Feb. 10, when the court will hear the defense’s motions to dismiss charges against Holmes and Balwani, the article said.

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