Critics Slam FDA Proposed Off-Label Rules

FDA wants to lop off part of its off-label drug and device regulations. While industry sees the change as a clarifying edit, critics are calling foul.

Nancy Crotti

In a proposed update to tobacco regulations, the agency wants to delete a section that requires drug and device companies to "provide adequate labeling" for non-FDA approved uses that the companies know of. The proposal would update FDA's description of "intended use" of a device or drug to clarify that the agency "does not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm's knowledge that such product was being prescribed or used by doctors for such use."

In other words, even if a drug or device company knows its product is being used off-label, FDA will not assume that was the manufacturer's intention. "These changes would not reflect a change in FDA's approach regarding evidence of intended use for drugs and devices," the agency concluded.

Some patient advocates worry that companies will use the proposed rule as a loophole to escape liability for harm caused by off-label uses, according to a report by the Star Tribune of Minneapolis.

"The FDA has done something that worries us regarding off label use, but they made a change that applies to drugs and devices but put it in rulemaking for tobacco products," wrote Diana Zuckerman, president of the nonpartisan health policy think tank National Center for Health Research, in an email statement.

The newspaper quoted an FDA spokeswoman as saying that FDA does not enforce the section of the "intended use" regulation that it wants to delete from the law. It will use other means of monitoring drug and device for misbranding their products or improperly promoting their off-label use, the newspaper said.

FDA declined to comment on the newspaper's characterization of its intent.

"The FDA has already stated this position," an agency spokesperson wrote in an email statement to Qmed. "The FDA is taking this action to ensure our regulations reflect how we currently interpret and apply the law. The amendment has no bearing on promotional activity or other evidence of intended use."

"We know that there are a lot of things that the FDA does not enforce," the Star Tribune quoted Zuckerman as saying. "We don't think the answer is getting rid of the laws they are not enforcing."

While medical devices are granted clearance or approval by FDA for a prescribed indication, off-label use is legal in many circumstances and is up to a doctor's discretion.Off-label use can range from 10% to 20% of drugs and medical devices, according to the American Medical Association.

It can also land manufacturers in oceans of hot water--particularly when the DOJ believes healthcare companies are getting reimbursed from Medicare or Medicaid for products that are being used off label. For example, Medtronic agreed a year ago to pay the U.S. government $2.8 million to resolve accusations that it encouraged off-label use of a spinal cord stimulation device.Medtronic denied any wrongdoing in making the settlement.

Medtronic also declined to comment for this story, referring inquiries to medical device industry trade group AdvaMed for comment.

FDA's proposed rule would "reduce ambiguity," according to a statement from Khatereh Calleja, AdvaMed's senior vice president for technology and regulatory affairs.

"The proposed rule would not create a loophole for off-label use. On the contrary, it would help ensure focus on manufacturers' claims as to product use," Calleja wrote. "Manufacturers take their responsibilities seriously and may not promote off-label use.  Finally, it's important to note that it reflects our long understanding of the regulations. While this proposed change was initiated by FDA, not industry, it is generally viewed by industry as a noncontroversial clarifying edit."

In the pharmaceutical realm, a number of executives have argued successfully that off-label promotion is protected as free speech. In the device realm, Vascular Solutions CEO Howard Root and former Acclarent executives William Facteau and Patrick Fabian are making similar arguments in a lawsuit that could help establish boundaries regarding what constitutes legal and illegal promotion of medical devices.

Like what you're reading? Subscribe to our daily e-newsletter.