New England Journal of Medicine
“Regulating Off-Label Promotion—A Critical Test”
Nov. 2, 2016
Recent court decisions have expanded the rights of pharmaceutical companies to promote “off-label” (nonapproved) use of drugs in their marketing and sales efforts. But that could spell serious trouble for patients buying and using products in ways that have not been scientifically tested, says University of Arizona Law professor Christopher Robertson in a new opinion piece published in the New England Journal of Medicine.
Robertson is the associate dean for research and innovation and head of the university’s Regulatory Science Program, a collaboration between Arizona Law and University of Arizona Health Sciences.
Robertson and coauthor Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, argue that the Food and Drug Administration’s (FDA) current premarketing approval process, which evaluates a drug’s claims about safety and efficacy regarding both original and intended use “remains a key way of ensuring that health care is based on robust science, so that patients are protected and wasteful spending is minimized.”
However, recent legal battles have shifted the notion of what should be allowable when it comes to promoting off-label uses of a drug.
Most notably, a 2012 U.S. Court of Appeals decision overturned the conviction of pharmaceutical sales representative Alfred Caronia, who had been found to be in violation of the Food, Drug, and Cosmetic Act (FDCA) because his sales pitches promoted using a drug for nonapproved purposes. The court said his sales pitches were protected commercial speech under the First Amendment.
That decision “subverted decades of presumptions about how the government could oversee the behavior of the pharmaceutical and medical device industries,” the authors write. “However, until the Second Circuit’s Caronia decision, if a company promoted intended uses that had not been FDA-approved, that promotion would be clear evidence that the product was misbranded and that its sale for those uses was illegal.”
In light of Caronia and other similar cases, FDA regulations are facing new scrutiny, with the pharmaceutical industry calling for rollbacks. Robertson and Kesselheim say that’s a dangerous development.
“We hope the FDA continues to stand on principle. The U.S. Constitution should not be misconstrued in such a way as to undermine the primary functions of federal regulation in this area: to protect patients and to create a high-quality market for drugs and devices that is driven by science rather than hype.”
Read the full article here.