Are FDA off-label marketing rules trampling on drugmakers' First Amendment rights? Par Pharmaceutical ($PRX) has just become the second drugmaker to say so. The company has sued the FDA, saying the agency's rules prohibit it from talking about its Megace ES drug to doctors who might prescribe it off-label. And that denies its constitutional right to "provide truthful information" about the drug, Par maintains.
Par's claims follow a similar lawsuit filed by Allergan ($AGN), which claimed the FDA improperly prohibited it from talking about off-label uses for its Botox injection. The company said it sued "to gain better clarity" about drugmakers' rights to share scientific and medical information with doctors and other healthcare providers. The company dropped its suit as a prerequisite to negotiating an off-label settlement with the Justice Department that included a guilty plea to marketing Botox for unapproved uses.
Like Allergan, Par claims it should be able to distribute "truthful" information to doctors. But Par's claims are a bit narrower. According to the company, it's restricted from talking to doctors about on-label uses--in patients with anorexia, cachexia or AIDS-related wasting--simply because those same doctors might prescribe Megace for off-label use, for instance, to treat wasting in elderly patients.
Not only is the restriction "contrary to the First Amendment," it's also "unjustified, since off-label use is lawful, widespread, medically necessary and reimbursed by the federal government under the Medicare and Medicaid programs," Par claims in its suit. Still, the company says, it wants clearance to talk about on-label information.
- get the Par Pharma release
- read the Dow Jones story