Drug, Device Industries, Patient Groups Differ on Off-Label Communications


The drug and medical device industries want the FDA to allow them to give more information to payers and health-care professionals about off-label, or unapproved, uses of their products to help them make decisions.

In comments to the Food and Drug Administration, industry groups said payers and health-care professionals want more information about the safety, effectiveness and value of treatments and while the labeling provides important treatment information, it doesn’t provide information that is learned about treatments over time. But consumer groups told the agency they are against loosening the FDA’s restrictions on off-label communications because doing so would put patients at risk. The industries were responding to a memorandum the FDA released in January laying out the issues. Comments were due April 19 (Docket No. FDA-2016-N-1149).

The drug and device industries have been pushing the FDA to clarify its policy on medical product communications for a long time. Under long-standing policy at the FDA, companies can be subject to criminal prosecution and civil liability if they promote their products for uses the FDA hasn’t specifically approved. Industry has criticized the policy as unduly restrictive and claims it infringes manufacturers’ free speech rights. President Donald Trump’s nominee to head the FDA, Scott Gottlieb, has indicated he would consider relaxing the restrictions on off-label communications.

Bradley Merrill Thompson, a Washington-based health-care attorney with Epstein Becker & Green PC, told me “we are all here to serve the patient, and to do what is in the patient’s best interest. So if there is a difference of view between industry and patient groups, those differences really need to be worked out keeping the patient at the center of the discussion.” Thompson also is a Bloomberg BNA advisory board member.

Thompson said he “would encourage the industry groups and patient groups to get together and talk about this, and sort it through to determine exactly what the core difference is. If there is an approach that would best serve patients, that approach should win out.”

“That said, not every patient group truly represents all patients. And indeed, sometimes differences of opinion are not really based on intellectual differences regarding facts, but a lack of trust,” Thompson said. “If the issue is trust, then industry needs to work to figure out how to build up that trust.”

Read my full article here.

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