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Viagra’s link to blindness a sign of FDA’s impotence

Friday, May 27, 2005
FDA needs strong law passed to act quickly on
safety problems like viagra-blindness link

Bill pending in Congress would give FDA authority to demand
new safety studies from drug maker when problems arise

(WASHINGTON,D.C.) – A reported link of blindness in men who take Viagra and other impotence drugs underscores the need for Congress to pass legislation that would allow the Food and Drug Administration to require drug makers conduct studies to determine if there is a blindness risk, Consumers Union said today. Currently, the FDA has no authority to require such post-market safety studies.
“Most Americans would be shocked to learn the government can’t require the maker of Viagra to conduct a study to determine if its drug may lead to blindness,” said Rob Schneider, manager of Consumers Union’s prescription drug advocacy project. “Congress needs to get serious about drug safety and stop allowing the pharmaceutical industry to game the safety system.”
News reports today disclosed that the FDA has received more than 40 reports of a type of blindness in men taking impotence drugs, mostly Pfizer’s Viagra. An FDA spokesperson said the agency has not determined if there is a cause and effect due to Viagra use, but is “evaluating” the situation. News reports indicate that physicians began reporting the possible link to the agency in 2001.
A Pfizer spokesman said the company is in discussions with the FDA to “update our language to reflect these rare ocular events that have occurred.” Currently, once a drug is approved, the FDA cannot require a drug maker to change the safety disclosures or other information on the label.
“Why shouldn’t government regulators have the authority to require drug makers place safety warnings on labels? It just doesn’t make sense,” Schneider said.
A bipartisan bill pending in Congress introduced by Sens. Charles Grassley (R-Iowa) and Christopher Dodd (D-CT) would give the FDA the authority to require drug makers to change labels and include new safety disclosures in advertisements. It also would give the FDA the ability to require drug makers’ like Pfizer to conduct safety studies of their products on the market once safety concerns arise.

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Susan Herold or Matt Hartwig, (202) 462-6262