Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Off-label marketing is an illegal yet commonly employed sales strategy that some big pharmaceutical companies practice to broaden the appeal of a drug and boost sales. One of the most blatant examples of off-label marketing involved Bayer Healthcare’s blockbuster birth control pill Yaz. Bayer promoted the drug as a treatment for premenstrual dysphoric disorder (PMDD) symptoms and to clear up moderate cases of acne when the FDA approved it as birth control only. Bayer stopped the deceptive marketing of Yaz when the FDA cited it for false and misleading advertising.

After Bayer was admonished over its Yaz ads, attorneys general of 27 states joined the FDA in cracking down on misleading consumer advertising. In 2008, the FDA ordered Bayer to create new, corrective ads that clearly communicated the drug’s approved uses and risks. The new commercials cost Bayer about $20 million, just a minute fraction of the hundreds of millions Yaz earns Bayer each year.

$20 million, in big pharma terms, is a slap on the wrist – if even that. Bayer’s deceptive Yaz promotions earned the company many millions more. $600 million more, to be more precise. Unfortunately, Bayer’s dishonest and highly questionable marketing scheme paid off.

Johnson & Johnson execs are also playing dumb and forgetful now that former sales representatives are stepping forward with lawsuits alleging the company pressured them to push the drug Risperdal for unapproved uses. The FDA approved Risperdal for use in adults with schizophrenia, but Johnson & Johnson wanted its reps to persuade doctors to use it as a treatment for bipolar disorder in children.

36-year-old Lynn Powell filed a lawsuit against Johnson & Johnson in a New Jersey court, claiming that the company fired her from her sales position in 2004 when she complained she was being pressured to sell Risperdal as a treatment for children and others even though the FDA had approved it for use in schizophrenic adults only.

When Powell’s attorney asked Matthew Thompson, Powell’s supervisor at the time she was fired, if he was aware that making off-label claims was illegal, Thompson replied “I probably was.”

With powerful drug companies calling the shots in Washington and putting profits over people, it can’t hurt to explore the FDA-approved uses of the pharmaceutical medications you take. Always consult your doctor and pharmacist if you have any questions or concerns about the prescriptions you take.

This entry was posted on Tuesday, November 10th, 2009 at 9:04 am and is filed under Legal, product liability, safety, toxic injury. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.