A Pfizer Whistleblower, Lipitor Marketing And Free Speech Rights

Will free speech rights factor into a long-running dispute between Pfizer and a former executive over guidelines used to market its Lipitor cholesterol pill? The issue is being raised by Jesse Polansky, who filed a whistleblower lawsuit accusing the drugmaker of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines. He also charged Pfizer paid kickbacks that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare. A federal judge dismissed his case last fall and he is now appealing (back story and here is his lawsuit). In his legal brief, the former director of outcomes management cites a controversial court ruling last winter about off-label marketing and the First Amendment rights that allow drugmakers to promote their products, so long as they do not make false or misleading statements. The ruling questioned a fundamental premise long asserted by the FDA that off-label promotion is prohibited by law (here is his brief). In that case, a panel of the US Court of Appeals for the Second Circuit overturned the conviction of Alfred Caronia, a former sales rep for Jazz Pharmaceutical, who allegedly encouraged doctors to prescribe a drug on an off-label basis. He argued that the government is not permitted to criminalize truthful promotion and the court ruled that his conviction violated his First Amendment rights (back story and the ruling). Polansky points to this ruling to underscore the contentio...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs