Recent court decisions have broadened commercial free speech rights to give pharmaceutical companies greater leeway to promote the off-label use of drugs. A Viewpoint published Monday in JAMA warned the courts' actions may turn the marketplace for medicine back "to a time of more claims and less evidence to guide clinical care."
As an example, they cite the case decided in August by Federal District Court Judge Paul Engelmayer. He stopped the Food and Drug Administration from requiring Amarin Pharma to label its fish-oil derivative drug called Vascepa, which is approved for lowering triglycerides, as unproven in preventing cardiovascular disease.
In a close reading of the judge's decision, Dr. Joshua Sharfstein, a former FDA deputy administrator now at the Johns Hopkins Bloomberg School of Public Health, and Alta Charo, a law professor at the University of Wisconsin, accused Engelmayer of misreading the FDA's label to mean the agency was forcing the company to say the drug fails to prevent heart disease. "The FDA's language implies no such thing," they wrote. Allowing Amarin to market its drug in a way that implies some heart disease benefit "is precisely what FDA found misleading."
If the judge's ruling stands, they warn, physicians may wind up making decisions based on "information of unknown quality from a self-interested source.... Judges should refrain from using the First Amendment to undermine core regulatory functions," they conclude.
