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.