FDA Legal Challenges
The FDA ban on promoting so-called off-label uses for drugs and medical devices is now being challenged in federal court as an unconstitutional restriction on commercial free speech. This coming term, the U.S. Second Circuit Court of Appeals will hear the case, which could over-turn the ban and make it easier for doctors and patients to learn about beneficial new uses of approved medical products.
In a forthcoming study for the publication Health Matrix: Journal of Law-Medicine [http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1677609], CEI Senior Fellow Gregory Conko explains why the FDA policy violates the First Amendment and why freeing up manufacturer speech would have important benefits for American patients.
“Doctors and their patients reap tremendous benefits from the distribution of truthful and non-misleading information about effective off-label uses. But the FDA’s ban on manufacturer promotion compromises the ability of doctors to learn about important treatment options. Given the recognized value of open discourse on scientific and health matters, as well as the importance of off-label prescribing in patient care, it is far from clear that the blanket restriction on off-label promotion actually advance the government’s broader interest in promoting public health. It is clear, however, that the ban is an unconstitutional restriction on commercial speech.”
Obama's Broken Pledge
Politicians and pundits have debated whether the stimulus has worked over the last few months. However, it is often overlooked where all the money went.
"Most people doubt Congress’ ability to spend money wisely. The stimulus has given them some proof."