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Drug safety board needs real independence, authority

Tuesday, Feb. 15, 2004

‘Independent’ Drug Safety Board Symbolic Step but Needs Real Independence, Authority

(Washington, D.C.) – Today’s announcement that the Food and Drug Administration will create an “independent’ drug safety oversight board must be backed up with vigorous enforcement of current safety laws, and passage of new laws that require drug companies to make their clinical trials public and allow for a truly independent Office of Drug Safety, Consumers Union said today.

“This is a symbolic first step, but until drug companies are required to make all their information on potential safety problems public, this board can’t ensure consumers will know about possible harmful drug side effects,” said Rob Schneider, Consumers Union legal counsel and manager of its Prescription for Change campaign.

Consumers Union said that the board announced by Health and Human Services Secretary Mike Leavitt cannot be truly independent if it will be made up entirely of government staff, while outside medical experts, patient and consumer groups serve only in a “consultant” mode.

“How can we have an independent board if it is made up entirely of government officials appointed by the agency?” said Janell Mayo Duncan, legislative and regulatory counsel. “Considering reports that FDA staff have been pressured to change or downplay safety concerns, we would like to see a concrete plan on how the board will truly be independent.

Consumers Union continues to call for legislation requiring a mandatory, public clinical drug trial registry and an Office of Independent Drug Safety to help ensure drug safety.

“We need an independent drug safety office with scientific staff that can quickly identify unreasonable health risks, and quickly notify the public of those concerns,” Duncan added.

Consumer groups are looking to the Senate to ask FDA commissioner nominee Lester Crawford tough questions about whether he supports legislation that provides meaningful drug safety and transparency. Crawford, who has been acting FDA director for the majority of the past four years, was tapped by President Bush Monday to permanently head the agency.

Contact: Susan Herold, 202-462-6262