November 9, 2016 (Washington, DC)—Vikas Saini, MD, president of the Lown Institute, is testifying today at the U.S. Food and Drug Administration’s public hearing against the proposed industry marketing of unapproved uses of approved or cleared medical products, citing patient safety concerns.
Off-label use refers to uses of a drug or device for a condition or diagnosis other than the one for which the product received prior FDA approval. While physicians are permitted to use medical products off-label, companies are not allowed to market them for off-label use because they have not been proven safe or effective specifically for other uses.
The FDA is considering relaxing these rules, largely due to pressure from pharmaceutical companies and medical device makers. If relaxed, patients would be at risk from products that have no scientific backing for certain uses, and out-of-control spending on these products would be exacerbated.
As a scheduled speaker at the FDA, Saini, a clinical cardiologist and co-founder of a medical device company, is in a unique position to comment on the dangers of off-label marketing. The delivery of inappropriate medical services, or overuse, is a significant national problem, and off-label marketing already helps drive overuse under current regulations.
“If companies are to be permitted to promote such use legally, they should be held to high evidentiary standards by the FDA in order to protect patients,” Saini said. “To loosen the regulations now would be in direct conflict with the mission of the FDA, and if we are honest about it, would serve primarily to expand corporate sales.”
Saini was joined by others testifying against off-label marketing, including television screenwriter Jeremy Lew, who in 2009 suffered a catastrophic injury when his surgeon removed a bone and two discs from his neck and replaced them with a device that was labeled for use in the spine below the neck.
The agency is holding a two-day hearing, prompted by recent court cases that argued that the First Amendment gives sales representatives the right to promote off-label uses to physicians.
Saini’s testimony is here.
About the Lown Institute
The Lown Institute, a nonprofit, action-driven think tank, is dedicated to transforming the culture of medicine and building a health care system that is affordable, effective, personal and just. The Institute was founded by renowned cardiologist and Nobel Peace Prize recipient, Bernard Lown, MD, and supports his vision for compassionate health care. Visit www.LownInstitute.org and follow us on Twitter at @LownInstitute.
Director of Communications, Lown Institute