Top FDA Officials' have "EMPTY" calendars-- Meetings with Industry Kept Secret

The Associated Press reports (below) that a review by Congressional Republican staff revealed that "for years, the public calendars of Drs. Janet Woodcock and Steven Galson were largely blank--devoid of the required detail about their contacts with the industry they regulated."

Dr. Woodcock occupied two top positions between 1999 and 2006--as director of the Center for Drug Evaluation and Research (CDER) and then Deputy Commissioner. Dr. Galson replaced her as head of CDER.

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 FDA, in responding to a Congressional inquiry, attributed the failure to publicly disclose meetings attended by the officials to administrative oversight. "As soon as it was brought to my attention, we corrected it," Galson told The Associated Press.

Woodcock did not respond to telephone and electronic messages seeking comment. Agency spokesman Robert Ali reiterated that it was an oversight, but couldn't say why it affected only Galson and Woodcock and not other officials. Nor could he say why the problem with Woodcock's listings persisted even after she changed jobs.

FDA officials' arrogance and disregard for rules governing public officials is matched only by the Vice President--who claims to be above all laws and regulations.
See: FRANK RICH. When the Vice President Does It, That Means It's Not Illegal. The New York Times July 1, 2007 [Link]

Where checks and balances are dysfunctional there is no democracy.

[Link] The Associated Press FDA Officials Criticized for Secrecy By ANDREW BRIDGES Saturday, June 30, 2007

WASHINGTON -- For years, the public calendars of two 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 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.

A review by House Republican staff found the public calendars for Drs. Janet Woodcock and Steven Galson virtually empty. Woodcock is a deputy FDA commissioner and former drug chief. Galson is current drug chief.

There were just three listings for Woodcock between January 1999 and December 2006, even though she occupied two 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 that the two had met during that period with drug company executives, lobbyists, patient 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 all the same.

"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," said Mary Boyle, a spokeswoman for the nonpartisan watchdog group Common Cause.

Rep. Bart Stupak [Link] , 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.

The FDA, in responding to a Congressional inquiry, attributed the failure to publicly disclose meetings attended by the officials to administrative oversight. "As soon as it was brought to my attention, we corrected it," Galson told The Associated Press.

Woodcock did not respond to telephone and electronic messages seeking comment. Agency spokesman Robert Ali reiterated that it was an oversight, but couldn't say why it affected only Galson and Woodcock and not other officials. Nor could he say why the problem with Woodcock's listings persisted even after she changed jobs.

"The important thing, obviously, is we were able to go back and reconstruct everything," Ali said.

Frequent FDA critic Dr. Sidney Wolfe called it "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, Wolfe said, who spend the most time meeting face-to-face with drug companies.

"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," said Wolfe, of the watchdog group Public Citizen.

Indeed, separate findings recently released by Stupak and fellow Democrat Rep. Maurice Hinchey [Link] 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.

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