Clinical Trial Transparency — Antidote to Weaker Off-Label-Promotion Rules?
New England Journal of Medicine
By Kevin Outterson, School of Law
This year promises to be an auspicious period for some long-running battles over the dissemination of biomedical research. Some companies seeking more freedom to promote their products have bristled at recent guidance documents from the Food and Drug Administration (FDA) regarding promotion of drugs and devices for off-label uses, claiming that they violate the First Amendment…