On Monday, Janet And Steve Were….Uh-Oh
1 CommentBy Ed Silverman // July 2nd, 2007 // 8:04 am
If you had a chance to check the public calendars for two top FDA officials between 1999 and 2006 - deputy commish Janet Woodcock and Steve Galson, who heads the Center for Drug Evaluation and Research - you’d think they either weren’t doing anything or didnt want to tell you what they were doing. That’s because their calendars were almost entirely blank.
And that’s a no-no. 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, the Associated Press reports. Once notified by congressional staff, the FDA began to retroactively fill in the calendar, and it showed that the two had met during that period with drugmaker execs, lobbyists, patient groups and others.
The FDA, in responding to a Congressional inquiry, attributed the failure to administrative oversight. “As soon as it was brought to my attention, we corrected it,” Galson tells the Associated Press. FDA spokesman Robert Ali reiterated it was an oversight, but couldn’t say why it affected only Galson and Woodcock, and not other officials. He also couldn’t say why the problem with Woodcock’s listings persisted even after she changed jobs; she previously had Galson’s job. “The important thing, obviously, is we were able to go back and reconstruct everything,” he says.
There is no punishment for failing to disclose the info, but open government experts called it crucial to make public all the same. Open government experts and lawmakers said it is only 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.
“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. That’s part of the process of assessing what’s going on at FDA and are decisions being made in the best interest of the public,” says Mary Boyle, a spokeswoman for the nonpartisan watchdog group Common Cause.
Rep. Bart Stupak, D-Mich., says 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 says. “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.
Public Citizen’s Sid Wolfe sys it’s “ridiculous” that the FDA had failed to post the calendar listings but suggested the requirement should be expanded to cover even lower-level employees at the agency. It’s those employees who spend the most time meeting face-to-face with drugmakers.
“Before decisions that seem to be going in the wrong direction from the public health perspective, it might be nice to know a company was in there,” he says.
Separate findings recently released by Stupak and fellow Democrat Rep. Maurice Hinchey of New York revealed how much time those lower-level FDA employees can spend in meetings with the drug industry.
The FDA disclosed, in response to questions posed by Hinchey, that agency officials met 112 times, between October 2005 and December 2006, with representatives of the drug industry to negotiate the agency’s proposal for reauthorizing the prescription drug user fee act program. Under that program, drug companies pay the FDA fees to have their products reviewed, exacting in return target timelines that make the process more predictable and expeditious.
No senior FDA leaders attended any of those meetings, except for a single meeting at which Woodcock appeared, according to Stupak and Hinchey.
Laurie
“The important thing, obviously, is we were able to go back and reconstruct everything,â€
Somehow I don’t take alot of comfort from that line.