By Naomi Lopez Bauman
After some delays, the Trump administration has finally unveiled their highly anticipated pharmaceutical pricing reform proposal, American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
But a closer look at the blueprint might reveal an even more far-reaching reform agenda.
Take, for example, recommendations that seem to open the door for more communications about off-label treatments. Off-label treatments account for about one in five prescriptions and occur when the medicine has been approved for use by the FDA, but the doctor prescribes it for a different purpose, patient population, or dosage than the FDA approved. While these treatments are perfectly legal, the FDA generally prohibits pharmaceutical companies from sharing information about “off-label” uses with doctors and insurers.
The President’s proposal states that the FDA “will facilitate opportunities for enhanced information sharing between manufacturers, doctors, patients and insurers to improve patient access to medical products…” This could be an important step toward enhancing patient care.
As the Goldwater Institute’s work has repeatedly highlighted, off-label speech restrictions not only undermine patient care but also violate the free speech protections in the federal and state constitutions. The Goldwater Institute developed model state legislation that seeks to restore the right to freely exchange truthful information about legal treatments, providing healthcare providers and payers with the tools they need to make informed healthcare decisions for patients.
The Free Speech in Medicine Act passed the Arizona legislature unanimously and was signed into law last year. And just last week, similar legislation was signed into law in Tennessee after unanimously passing both of their chambers. This year, several more states have introduced and are drafting similar bills.
Building upon the Goldwater Institute’s research into the legal and policy issues surrounding this issue, the Federalist Society’s Regulatory Transparency Project released Christina Sandefur’s legal analysis, The FDA’s Approach to Off-Label Communications: Restricting Free Speech in Medicine?, earlier this week.
Right to Try
In what appeared to be off-script remarks, President Trump also re-affirmed his commitment to federal Right to Try legislation at the ceremony unveiling the plan. Congress has passed two different, but similar versions of the legislation. Forty states have now passed state Right to Try laws and more are expected to pass legislation. It is heartening to see that this important issue remains in the forefront of Washington’s attention.
There are dozens of recommendations in the blueprint, and more details are scheduled to be released in the coming days. If the agenda remains true to their theme of putting patients first, then there may be reason to celebrate.
Naomi Lopez Bauman is director of healthcare policy at the Goldwater Institute.