Feds Seek to Overhaul Nation’s Prescription Drug Model

By Jonathan Springston, Editor, Relias Media

Building on the success of making insulin cheaper, it appears the Biden administration is seeking more ways to lower the costs of other common drugs while expanding access and speeding delivery of innovative therapies.

In a recent executive order, President Biden directed the Department of Health and Human Services to submit a report to the White House within 90 days that outlines how the United States can “lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs, including models that may lead to lower cost-sharing for commonly used drugs and support value-based payment that promotes high-quality care.”

The Centers for Medicare & Medicaid Services Innovation Center, which develops and tests new healthcare payment and service delivery models, is expected to play a central role in this initiative. “In June 2022, the Innovation Center announced a new model to improve cancer care and lower healthcare costs for cancer patients, including prescription drug costs. The Innovation Center provides my administration and the American people with a useful set of tools to help lower healthcare costs and improve quality of care, and its work can advance the continued policy of my administration to lower the cost of prescription drugs,” the president wrote in his order.

Meanwhile, the FDA has opened for public comment a proposal to modify existing regulations regarding distributed manufacturing (DM) and point-of-care (POC) manufacturing, which the agency believes could “improve the reliability and robustness of the drug supply chain.”

“For example, a healthcare facility could be interested in using a POC manufacturing technology to meet the specific needs of its patients, or DM units could be deployed at a location following a public health emergency to meet local demand for certain drug,” the agency explained. “Though there are currently no FDA-approved drugs being manufactured using DM or POC technology, the agency is proactively evaluating our existing risk-based regulatory framework as it applies to these technologies. The agency recognizes feedback from drug manufacturers and other stakeholders involved in the development of DM and POC technologies is critical to help inform the FDA’s evaluation of our existing regulatory framework.”

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