FDA's sharing of grand jury information
comes under criticism
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[September 13, 2016]
By Sarah N. Lynch
WASHINGTON (Reuters) - An office inside the
Food and Drug Administration routinely shares details internally about
criminal matters pending before grand juries, a step some lawyers say
may run afoul of rules meant to safeguard investigations.
FDA agents send updates about anticipated grand jury testimony and
indictments to more than two dozen people, many of whom have nothing to
do with the case, emails from the agency’s Office of Criminal
Investigations, OCI, show.
The e-mails, known as "headquarters alerts," give FDA brass a heads up
about expected actions inside or outside of court – such as arrests, the
execution of search warrants, grand jury indictments or jury verdicts –
so managers can prepare for possible press coverage.
Managers in the Rockville-based criminal investigations office require
agents in the field to send these emails, internal communications and
interviews show.
Yet section 6(e) of the Federal Rules of Criminal Procedure imposes
strict secrecy requirements on government employees, including
prosecutors and agents investigating cases pending before grand juries.
This secrecy is designed to protect the integrity of the government's
investigation and the rights of subjects facing possible indictment.
Under rule 6(e), the disclosure of a grand jury matter may only be made
to government employees whose names are on a list on file in the court
where the grand jury is impaneled. Only those deemed "necessary to
assist" government lawyers can be designated, and each is to be advised
to keep the matter confidential.
The FDA's "headquarters alerts" emails are typically sent to dozens of
people inside the criminal office, according to copies seen by Reuters.
Recipients include office managers, a training coordinator and a public
affairs official.
Others receive them even if the case doesn't touch upon their subject
expertise. Agents who specialize in food and tobacco receive information
about drug cases, for instance.
In an interview, OCI Director George Karavetsos said he does not believe
the emails violate grand jury secrecy rules.
“Discussing those things that are going to happen prospectively or have
not yet happened, meaning that they may or may not happen, don’t
necessarily violate 6(e),” he said. “I have not seen anything that has
violated 6(e).”
A person who knowingly or willfully violates the rule can be held in
contempt by a federal court.
The FDA Office of Criminal Investigation's handbook says only people
whose names have been filed with the court are allowed to know “about
the jury's activities, such as whether the grand jury has issued a
subpoena to someone.”
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Even the mere "fact" that a grand jury has been convened or issued
subpoenas should be disclosed on a need-to-know basis through the proper
channels, it says. "Neither FDA colleagues nor supervisors may be
advised of the substance of grand jury activities unless they have been
designated.”
Adam Kurland, a former federal prosecutor who teaches criminal law at
Howard University, said it is "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 list is properly designated, he
said, the FDA is likely in violation of the rules. "It sounds like the
FDA PR machine has gotten ahead of itself," he said.
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Solomon Wisenberg, a defense attorney at Nelson Mullins Riley &
Scarborough LLP, called the FDA’s denial that it was breaking rules
“bulls---” and said he felt “almost any federal judge” would agree
it is improper.
Some attorneys disagree, saying the FDA’s actions, while
questionable, may not necessarily violate rules. Court districts
vary in how strictly they interpret grand jury secrecy rules.
“The expectation that certain information is going to be presented
to a grand jury is not necessarily 6(e),” said James Felman, a
defense attorney with Kynes, Markman & Felman.
Among the e-mails in question: One dated January 12, 2016 containing
an attachment saying a special agent in Puerto Rico planned to
“present two indictments to a federal grand jury” the next day
against two men for their alleged role in a prescription drug
diversion scheme and the sale of physician drug samples. The arrests
of the two men, it says, were tentatively slated for January 14, the
day after the indictment was expected to be returned.
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Another email, sent January 20, 2016, discloses that a postal
inspector was slated to testify five days later before a grand jury
in support of an indictment against Averill Perkins for conspiring
to distribute misbranded, foreign-sourced Tramadol.
An attachment with the e-mail goes into greater detail, naming an
alleged co-conspirator expected to be indicted “in the near future”
by a grand jury in a different district.
Perkins was not indicted until seven days later, court records show.
There is no public record of any co-conspirator indictment.
Jake Watson, an attorney for Perkins, said he was "bothered" to
learn the FDA had internally shared information before an indictment
was filed.
Such concerns are not new.
In 2011, agents told the Health and Human Services Inspector General
that the FDA did not have built-in restrictions in the office’s
online case management system to prohibit access to grand jury
materials, and that managers in headquarters could access
information without being designated, according to a May 2012 report
by the inspector general.
The report also said the FDA's New York office did not follow policy
by restricting access to grand jury information to the office's
number one and two ranking officials. At the time, the FDA’s
response did not address the concerns.
Reuters examined the FDA’s handling of grand jury information as
part of a broader look at the OCI, a little-known unit where agents
carry guns and investigate crimes. The office has spent thousands of
hours investigating doctors who purchased imported misbranded drugs.
Yet more than half of all OCI cases from 2008-2015 were closed
without action, Reuters found.
Critics contend OCI’s approach protects drug makers as much as
consumers. The FDA said it follows leads from all sources to ensure
dangerous drugs do not infiltrate the market.
(Editing by Ronnie Greene)
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