Psychiatric News April 1, 2005
Volume 40 Number 7
© 2005 American Psychiatric Association
p. 48
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 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.
Related Article:
-
FDA Officials Divided Over Need for Policy Change
- Aaron Levin
Psychiatr News 2005 40: 1-48.
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