Big Pharma legal whiz sees DoJ, FDA crackdown on CEO quotes and press releases

Anyone reading the news this week knows what a stray remark from a CEO can do. But pharma executives don't have to mention "distressed babies"--or something equally telegenic--to get themselves in trouble.

These days, regulators are keeping a closer eye on CEO statements. The FDA recently slapped Aegerion Pharmaceuticals ($AEGR) with a warning letter after its CEO Marc Beer spouted off about a product on CNBC. The agency has gone after companies for press releases that step over the line, too. In one case, a CEO who wrote a press release ended up in prison.

That has people like Emily Wright, senior counsel at Pfizer ($PFE), worried. As Main Justice reports, Wright recently told a compliance conference audience that she expects the FDA and the Department of Justice to play Big Brother when it comes to statements in the media and in press releases.

"We've seen some in the past couple of years, and we might be starting to see this even more," Wright said (as quoted by Main Justice).

Pharma companies are familiar with the DoJ's gimlet eye on drug marketing, what with the many whistleblower lawsuits over the past several years. A who's who in the industry has dealt with U.S. Attorneys' Office probes into off-label promotions and other violations. Many of those investigations resulted in hefty fines, some in the billions of dollars. And the FDA's Office of Prescription Drug Promotion dispatches many a warning letter detailing infractions in brochures, commercials and print ads.

But a crackdown on sound bites and media quotes is something new. Wright said the Aegerion case, along with a few others, appear to be the leading edge of a trend. "It's been pretty significant in shaping the environment and pointing us to what we might see going forward," she said.

Since Beer's ill-fated appearance on CNBC, the Justice Department rolled out a subpoena for Aegerion, asking for information on its marketing practices. The FDA's worries about his remarks--that they could amount to off-label promotions--caught the DoJ's eye. The moral of this story? Read press releases very, very carefully. And make sure your CEO is well prepped, with Marc Beer in mind, before going on camera.

- read the Main Justice story

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