This weekly column offers opinions on the latest pharmaceutical industry news.
Drug makers are complaining that the Food and Drug Administration is leaving them speechless.
In a closely watched battle, two small companies have petitioned to give doctors information about unapproved, or off-label, uses for their medicines. Last week, Pacira Pharmaceuticals Inc. sued the FDA for the right to promote a post-surgery pain drug for a wider range of operations than federal regulators allow. The other company, Amarin Corp., wants to promote a fish oil pill.
Typically, drug makers must prove to the FDA that their medicines work to treat a specific disease before they can market them for that purpose. The agency thus bars them from promoting drugs for unapproved uses, though doctors routinely prescribe treatments for such off-label purposes.