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.
Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.
Learn more about Bloomberg Law and sign up for a free trial.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)