FDA Policy/General

OCI Internal Grand Jury E-mails Questioned: Reuters

Continuing its investigation into the FDA Office of Criminal Investigations (OCI), Reuters says that OCI agents routinely share details about criminal matters pending before grand juries with more than two dozen top agency officials. The news service says the “headquarters alerts” let the executives know about expected actions inside or outside of court, including arrests, search warrants, grand jury indictments, or jury verdicts, so that FDA managers can prepare for possible media interest. “Managers in the Rockville-based criminal investigations office require agents in the field to send these e-mails, internal communications and interviews show,” Reuters says.

The article references section 6(3) of the Federal Rules of Criminal Procedure that imposes strict secrecy requirements on government employees, including prosecutors and agents investigating cases pending before grand juries, and notes that attorneys have varying opinions on whether OCI is violating that section.

OCI director George Katavestos said “discussing those things that are going to happen prospectively or have not yet happened, meaning that they may or may not happen, doesn’t necessarily violate 6(e). I have not seen anything that has violated 6(e).”

But Adam Kurland, a former federal prosecutor now teaching law at Howard University, said it was “mind-boggling” that FDA “bureaucrats who should know better” are internally sharing details about who is testifying and what counts are being considered. Unless every single person on the e-mail distribution list was properly designated, he said, FDA is likely violating the rules in its own OCI handbook. “It sounds like the FDA PR machine has gotten ahead of itself,” Kurland suggested. And defense attorney Solomon Wisenberg said he believed almost any federal judge would agree that OCI’s actions are improper.

However, defense attorney James Felman said that “the expectation that certain information is going to be presented to a grand jury is not necessarily 6(3)."

The Reuters probe first looked at the low prosecution rate among cases investigated by OCI.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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