Yes or No to Independent Oversight?

Sen. Charles Grassley (R-Iowa) weighed in last month on what powers the Food and Drug Administration (FDA) should have over drug labeling and advertising of prescription drugs.

“We need reforms, both administrative and legislative, to bring greater responsiveness and transparency to the FDA,” said Grassley, according to news reports. Grassley, chair of the powerful Senate Finance Committee, said he was readying legislation to create an independent office with the power to order drug companies to add warning language to product labels.

Sen. Michael Enzi (R-Wyo.) of the Health, Education, Labor and Pensions Committee said last month that he opposed creating a separate office within the FDA (see story on Original article: page 1).

Controversies such as the one surrounding the withdrawal of COX-2 inhibitor Vioxx and use of antidepressants among children and adolescents indicated that“ the agency charged with protecting the public from unsafe prescription drugs is too cozy with the drug companies,” Grassley said in remarks to the Consumer Federation of America.

Asking the same divisions of the FDA that approve pharmaceuticals to monitor their postapproval use was not enough, he stated. The current FDA proposal for an Office of Drug Safety would place it within the Office of New Drugs, which approves new medications for use in this country. Grassley would prefer the creation of a separate office reporting directly to the FDA commissioner.