FDA urged to recognize need for exchange of info about unapproved uses of devices, drugs

Manufacturers of medical devices, including many in Minnesota, know a lot more about their products than they are allowed to tell doctors, patients and insurance companies.

In a widely anticipated hearing Wednesday, Minnesota-run Medtronic PLC joined with large drug companies in urging the Food and Drug Administration to recognize the importance of allowing a freer exchange of truthful health information about unapproved uses of doctor-prescribed health products.

"Manufacturers have superior access to information about their devices, especially … as new risks emerge" after approval, Medtronic's top regulatory lawyer, Sandra Kalter, said at the FDA meeting. Yet the FDA discourages companies from giving doctors the latest safety information on even the most common unapproved uses.

Doctors can use devices and drugs for unapproved uses, but FDA policy forbids manufacturers from promoting them. The three dozen speakers on the first day of the two-day hearing in suburban Maryland included companies urging greater freedom in talking about unapproved uses and advocates who underscored the dangers of unapproved uses to patients.

FDA Commissioner Dr. Robert Califf opened Wednesday's meeting noting that drugs and device history includes "tragic" examples of medical products marketed with false claims to doctors whose patients suffered harm.

Califf spotlighted recent cases involving marketing of powerful antipsychotic drugs for use in dementia patients for whom it was never approved. "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," Califf said.

California resident Jeremy Lew, who recently settled a lawsuit with Medtronic over injuries sustained from the unapproved use of a device to replace vertebrae in his neck, told an FDA panel that drug and device makers already peddle "half truth, untruth and mistruth" under stricter rules.

"If these are the liberties that the FDA is already extending to industry now, imagine what will happen should off-label regulations be loosened," Lew said.

But a device's or drug's FDA-approved product label, which includes a paper package insert and a lengthy document on the internet, simply cannot include all the information a doctor or insurer needs to understand the uses of product, other speakers said.

New medical science on devices and drugs is published far more quickly than it was when the labeling laws were written, some said. Current restrictions on explanations of off-label use also predate the ubiquity of the internet, where patients now easily find information from studies and publications that the FDA forbids companies to use in marketing, they added.

The system for updating product labels moves so slowly that limiting sales pitches to on-label information deprives the medical community and the public access to information about uses that are not only widespread, but 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," Kalter said. "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."

Some critics of the FDA's current restrictions believe they violate commercial free speech rights under the First Amendment, which has been recognized by some courts around the country in recent years.

"To be in charge of my healthcare, what do I need? I need knowledge," said Minneapolis medical device regulatory attorney Ralph Hall. "Constitutionally, there is not only the right to speak, there is the right to hear the messages."

Joe Carlson • 612-673-4779

Jim Spencer • 202-662-7432