The following statement by U.S. Food and Drug Administration Commissioner Scott Gottlieb was published June 12 on the FDA’s website:
“We’re living in a time of unparalleled scientific advancement. Innovative medical treatments continue to be developed at an astonishing pace and are delivering increasingly targeted and meaningful benefits. More patients have more opportunities to benefit their health. But to realize the potential of these scientific advances, American patients must be able to gain access to these innovations. That means they must be able to afford the resulting medicines. And the rising list prices of drugs can create an obstacle to access. This is especially true for patients who find themselves underinsured or uninsured for medicines.
Last month, Secretary of Health and Human Services Alex Azar set forth a sweeping blueprint to address this pressing challenge. Among the new steps, HHS highlighted the importance of linking payments for drugs to their value and committed to removing regulatory obstacles to value-based purchasing by payers.
This call to action is taking place against the backdrop of an information transformation. In the era of ‘big data,’ scientists, drug makers, regulators, payers and others have unprecedented access to new sources of information. Already, the ability to harness this information and use it to help establish the value of medicines is providing the foundation for a shift toward innovative, value-based payment arrangements.
The Food and Drug Administration, working with our sister agencies in the Department of Health and Human Services, can help nurture this change by providing clear guidance to pharmaceutical companies about open, responsible communication with payers, formulary committees and others. To advance these goals, the FDA is issuing updated, final guidance documents that provide greater clarity about our thinking and recommendations for certain medical product communications. In particular, this guidance will inform market participants developing contracts that include value-based arrangements how to communicate information about how a drug might impact outcomes that are important to purchasers like a health plan or hospital, but is not an endpoint that is expressly described in the drug’s approved labeling.”
To read the commissioner’s full statement on the FDA’s website, click here.