US advisers criticize FDA drug safety board

By Lisa Richwine

GAITHERSBURG, Maryland (Reuters) – Some outside advisers on
Friday criticized a major part of the government’s efforts to
improve drug safety, saying a new oversight board needs
independent voices and should consider meeting in public.

The Drug Safety Oversight Board was announced a year ago as
a step to help regulators quickly respond to signs of
unexpected side effects after a drug reaches the market.

Board members are senior U.S. Food and Drug Administration
officials, plus experts from other government agencies. They
meet periodically in private to discuss how to address emerging
issues. Brief summaries are released to the public.

The board is separate from other FDA drug safety activities
and an external advisory panel that provides input on drug
risks when the agency requests it.

Dr. Peter Gross, the advisory panel chairman, praised the
FDA as “incredibly competent” but said the board would benefit
from outside views.

“You are setting yourself up for failure with this
oversight board,” Gross told FDA officials at a meeting of the
advisory panel. “In this age of transparency, you decide to
have a committee that’s responsible, according to its name, for
overall safety, and yet it meets in private. You don’t have
public representatives.”

The board was established in the wake of Merck & Co. Inc.’s
recall of arthritis drug Vioxx and other safety controversies
that sparked criticism of the FDA’s oversight.

The board is a good step that “addresses some of the
perceived weaknesses,” said Dr. Curt Furberg, an adviser from
Wake Forest University School of Medicine in North Carolina.

Arthur Levin, director of the Center for Medical Consumers,
said the board’s name is misleading. “I don’t think it’s a drug
safety board…The model is bad, the name is bad. Why can’t
there be an audience?”

FDA officials said the board was designed to be an internal
management group, in part because officials must discuss
confidential company information.

Adding nongovernment members would require a lengthy
screening process for conflicts of interest that could delay
action on important issues, they added.