Calendars of 2 FDA drug safety aides nearly blank
Sunday, July 1, 2007
WASHINGTON - For years, the public calendars of 2 top federal drug safety
officials were largely blank - devoid of the required detail about their
contacts with the industry they regulated.
Open-government experts and lawmakers said it is the latest example of the
lack of transparency at the Food and Drug Administration and a violation of
the spirit of open government. The FDA attributed it to administrative
oversight.
A review by House Republican staff found the public calendars for Drs. Janet
Woodcock and Steven Galson almost empty. Woodcock is a deputy FDA
commissioner and former drug chief. Galson is drug chief.
There were 3 listings for Woodcock between January 1999 and December 2006,
even though she occupied 2 positions during that time that required her
meetings to be listed: director of the center for drug evaluation and
research and, later, deputy commissioner for operations. Investigators
found no listings for Galson, who took over the drugs office from Woodcock
on a full-time basis in July 2005.
Once notified by the congressional staff, the FDA began to retroactively
fill in the calendar. It showed the 2 had met during that period with drug
company executives, lobbyists, patients groups and others.
Federal regulations require the FDA to maintain a public calendar that
details all "significant meetings" between its top brass and anyone outside
the executive branch. There is no punishment for failing to disclose the
information, but open-government experts called it crucial to make public.
"It's important to disclose this kind of stuff so the public knows who these
high-ranking FDA officials are talking to and who has their ear," said Mary
Boyle, a spokeswoman for the nonpartisan watchdog group Common Cause. "That
is part of the process of assessing what is going on at FDA and are
decisions being made in the best interest of the public."
Rep. Bart Stupak, D-Mich., said this was an example of a lack of
accountability by the FDA. Stupak is chairman of the oversight and
investigations subcommittee of the House Energy and Commerce Committee,
which has been investigating the FDA. The report was compiled by Republican
staff members of that committee.
"There is a lot of harm there," Stupak said. "There is a plethora of
valuable information that can be gleaned by watchdog groups and others just
by knowing the date of the meetings, the context or content and who's
present."
The lack of entries stood in sharp contrast to those detailed by other
senior FDA officials. The FDA's chief veterinarian, Stephen Sundlof, for
instance, listed 263 meetings between 1999 and 2006, according to the
report.
2 FDA drug safety aides' calendars nearly blank 
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