FDA Raps Pfizer’s Warning of Defective Heart Valve : Medical: The agency says the firm’s national alert to doctors looked more like junk mail than an urgent message about a life-and-death issue.


Food and Drug Administration officials have criticized Pfizer Inc.'s program to warn doctors about the company’s potentially defective heart valve, contending that the national alert looks more like junk mail than an urgent message about a life-and-death issue.

“The whole package has the appearance of slick promotional material for a new product rather than a notice about an important public health issue,” Joseph S. Arcarese, an FDA training director, said in a Dec. 4 letter to Pfizer officials. “I’m very concerned that many office managers may discard the package as simply junk mail.”

Pfizer sent packages about its Bjork-Shiley Convexo-Concave heart valve to some 19,000 physicians around the country, informing them of an unprecedented effort to contact the 55,000 people implanted with the device.

At least 400 of the valves, manufactured by Pfizer’s Shiley Inc. unit in Irvine, have fractured. The valves have been blamed for the deaths of at least 265 people. Thousands of valve recipients are unaware of the potential flaw in the valves.


The FDA, however, said the message isn’t getting through because the warning isn’t packaged properly. The Pfizer package comes in an envelope that shows a picture of a man and woman talking to a doctor. The FDA wanted something more eye-catching, such as large red letters denoting the message’s urgency.

James Morrison, the FDA’s deputy training director, said Monday that an agency sampling of 24 doctors found that 12 never received the notice and five “didn’t know what it was about and threw it out.” He added, “They thought it was an advertisement.”

Robert Fauteux, a Shiley spokesman, said the company believes that the materials are adequate--at least for now.

“We believe it is attractive but modest,” he said. “We do not believe it is slick or promotional, and we believe the packaging reflects the high quality of the information that is enclosed.”

Because the FDA sampling of doctors was so small, Fauteux contended, it is too early to tell whether another mailing is required.

Nevertheless, Pfizer sent more than 19,000 telegrams on Saturday to doctors, telling them that the packages were on their way.

Those wishing a copy of the notice can call Medic Alert at (800) 245-1492.