FDA may allow medical companies to promote drugs, devices for off-label uses

The Food and Drug Administration is in the midst of a two-day hearing to discuss whether drug companies and devicemakers should be allowed to promote unapproved uses of medical products to physicians, reports Star Tribune.

While physicians can use devices and drugs for unapproved uses, the FDA prohibits manufacturers from speaking to physicians about these uses.

At the hearing, scheduled for Nov. 9 and Nov. 10, FDA Commissioner Robert Califf, MD, highlighted "tragic examples" of medical products marketed with false claims that harmed patients, according to the report.

"If firms are able to promote products for new uses without generating the kinds of data needed for a robust assessment [of safety and effectiveness] ... the important public health interest that the FDA advances could be compromised, and patients could be harmed," said Dr. Califf at the hearing.

Device and drugmakers argued a product's FDA-approved product label simply cannot contain all the information a physician or payer needs to understand the full scope of the product's uses, the Star Tribune reports.

They said new medical research on devices and drugs are published on the internet much quicker than the FDA can update product labels. They argued limiting sales pitches to on-label information denies the medical community and public crucial access to information about widespread uses that may even be covered by health insurance.

"Off-label use of devices can be an important part of medical practice and may constitute a medically recognized standard of care," said Medtronic lawyer Sandra Kalter at the hearing. "To provide high quality care and to safely use devices in the best interests of their patients, doctors must have adequate and timely access to information about these devices."

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