DeLauro: Industry Influence at FDA is Alive and Well

DeLauro: Industry Influence at FDA is Alive and Well

-Viagra Warnings Ignored Like Those of Bextra, Celebrex -

Congresswoman Rosa L. DeLauro (Conn.-3) today said the drug industry was heavily influencing the Food and Drug Administration (FDA). DeLauro's statement comes on the heels of a media report that an FDA safety officer warned Viagra use may be linked to blindness in some men. FDA did not notify the public of the potential side effects until 13 months after the officer's announcement when similar warnings were reported by the Journal of Neuro-Ophthalmology. DeLauro is ranking member of the House Appropriations Agriculture subcommittee, which oversees the FDA's budget.

"Ensuring the integrity of our drug supply for the benefit of public health should be FDA's priority," said DeLauro. "Yet, the evidence of industry influence at FDA continues to mount."

"After Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation, testified that he believed there was a heart hazard from using Celebrex at high doses, adding the problem may cover the whole class of drugs, which included Bextra, attempts were made to discredit him. Several months later, Bextra was recalled and strong warnings were issued about Celebrex.

"Recent news that FDA suppressed information by one of its own safety officers about the potential side effects for Viagra users is also questionable. Thirteen months later, a medical journal confirmed these side effects and the public was finally notified by FDA.

"FDA has demonstrated an inability to react to drug's harmful side effects, a failure to modify drug labels, and a determination to suppress harmful information about drugs. Industry influence seems to be alive and well at this agency."

http://www.house.gov/delauro/press/2005/July/FDA_industry_07_01_05.html