Frank Torti, the acting FDA commissioner, has an
important message for all agency employees--you won't make a peep if you
know what's good for you.
In an
unusual memo distributed last Friday afternoon, Torti ensured the
agency is committed to transparency and "the principles of open
government." But after dispensing with the obligatory qualifier, he then
went on to warn FDA employees the agency "must comply with its
obligations to keep certain information in its possession confidential."
He
then writes those obligations are spelled out in the Food, Drug, and
Cosmetic Act, the Freedom of Information Act (FOIA), the Trade Secrets
Act, and the Privacy Act, as well as FDA regulations. But if agency
employees violate these provisions, they may face disciplinary
sanctions, criminal liability and the FDA could be sued for damages.
Torti
cites five sweeping categories of info that must be kept under wraps:
trade secrets; confidential commercial info; personal privacy data; law
enforcement records and privileged intra-agency and inter-agency
documents, such as emails, memos and letters between between FDA
employees. This last category can be a veritable treasure trove,
however, because it can include opinions issued by FDA employees and
materials prepared in connection with litigation - the sort of stuff
that makes a good headline.
The missive, which an FDA spokeswoman
tells us speaks for itself, may have its roots in a recent pair of
embarrassing episodes that stemmed from the discussion or release of
what FDA officials may view as privileged info. Earlier this year, nine
FDA scientists wrote President Obama's transition team that the review
process for medical devices was ‘corrupted and distorted by agency
managers.'
An example surfaced last week in a report in The Wall
Street Journal, which detailed how a lobbying campaign overcame
internal dissent among FDA staffers, who objected to the approval of a
ReGen Biologics device for knee injuries. Former FDA commish Andy von
Eschenbach acknowledged the affair was handled poorly.
And last
month, the FDA removed
Sanjay Kaul, a well-known cardiologist at the Cedars-Sinai Heart
Institute in Los Angeles, from a meeting of its Cardiovascular-Renal
Drugs Advisory Committee at the last minute over the potential for
intellectual bias.
The move caused an uproar after it became
known that officials at Lilly, whose prasugrel blood thinner was to be
reviewed, called FDA offices prior to the meeting to complain about
Kaul, who had been openly critical of the drug. The FDA's head of the
Office of New Drugs, John Jenkins, later admitted the "disinvitation"
was a mistake.
It's unclear whether the memo is directly
related to either of those incidents, or if it was issued for more
general reasons, although a good source suggests the recent flaps likely
had a lot to do with it, because such memos are rare. In any event, one
thing is clear: we managed to get a copy, so it doesn't seem to have
struck too much fear in the hearts of FDAers. The irony of it all.
By: Ed Silverman
The In Vivo Blog
March 16, 2009
PDF version of article
|
