After years of controversy, the Food and Drug Administration has issued a proposed rule to clarify when manufacturers would have to update product labeling to reflect unapproved uses of their medicines.

In doing so, the agency has left intact a decades-old rule that stated drug makers must update labeling if there is evidence indicating a company intended its medicine to be used off-label, or for an unapproved use. Doctors are free to prescribe a medicine for any purpose, but court rulings have determined drug makers can make statements about off-label uses only if information provided is truthful and not misleading.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
  • Clear as mud, right? I don’t understand. A drug like Alecensa is approved to treatment non-small cell lung cancer patients where the tumor contains the ALK mutation. I have a patient who has a non-small cell lung cancer patient where the tumor as the ROS1 mutation. I know, like every other oncologist knows that ALK inhibitors work well for ROS1 mutations. But it is not FDA approved for ROS1. I do this (it gets paid for) but I am suppose to keep that information a secret from my pharma rep. If my pharm rep learns out my off label use, they are suddenly responsible for….. for what? For collecting data? For providing more data to the FDA? Seems strange. I mean, every expert in ROS1 mutations in lung cancer will tell you that these drugs work and work well. Why can’t the package insert allow use for ROS1 mutated lung cancer? Why is the rep not allowed to talk about it? Or even worse…. why can’t the rep even hear that I am using it?

  • And one supposes that this will be a rule Sect’y Azar will need to sign at some point, if he is still in the post when it comes to fruition? Or is this exempt?

Comments are closed.

Sign up to receive a free weekly opinions recap from our community of experts.
Privacy Policy