FDA steps-up warnings, low-level enforcement

Medical Marketing and Media, May 1998

The FDA appears to be issuing more warning letters, but has not accelerated the penalties, according to speakers at the Drug Information Association marketing program in New York City. One reason is because the FDA is devoting its resources elsewhere -- developing guidance and legislation, and responding to law suits, such as the one by the Washington Legal Foundation, according to attorney William W Vodra, senior partner with Arnold & Porter.

In 1997, the Division of Drug Marketing Advertising and Promotion sent 180 notice of violation letters - 61 were made public on the Internet -- according to Edward Zimney, M.D., director of medical regulatory affairs for Immunex Corporation. The companies receiving the most letters were Schering (seven), Merck (six), and Glaxo Wellcome, SmithKline Beecham, and Abbott each received four.

The promotional mediums most often involved were sales brochures (29), journal ads (11), and press releases (10). There were nine direct-to-consumer promotional violation letters covering seven products from five companies. In the letters, false and misleading, fair balance, and superior efficacy or safety statements were the violations most frequently mentioned, Zimney said.

"The FDA tries to make the remedy painful," said Michael Peskoe, assistant general counsel, regulatory affairs, for American Home Products Corp. There were remedial actions last year, such as corrective journal ads, "Dear Doctor" letters, and ceasing the violative promotion but no civil or legal actions were taken.

The actions "were not punitive, but expensive and embarrassing," Peskoe said. El