WASHINGTON, DC (June 20, 2017): The Council for Affordable Health Coverage (CAHC) – a coalition of employers, insurers, brokers, agents, patient groups, and physician organizations – responded today to testimony before the Senate Appropriations Committee from Food and Drug Administration (FDA) Commissioner Scott Gottlieb on the agency’s approval process for new drugs.
At the hearing, Commissioner Gottlieb announced a forthcoming “medical innovation development plan” that includes “a broad range of steps [FDA] will take to make sure that … regulatory tools and policies are moderate and risk-based and designed to facilitate the development of potentially breakthrough new treatments.” The policies outlined in the Commissioner’s testimony echo the consensus-based solutions offered in CAHC’s Prescriptions for Affordability initiative earlier this year.
For example, Gottlieb pledged to “improve efficiency” for clinical trials; which reflects CAHC’s recommendation that “regulatory requirements for clinical trials should be evaluated and reformed as needed to better foster innovation, reduce inefficiencies, and speed access to therapies.”
The FDA Commissioner additionally vowed to eliminate the agency’s backlog of orphan drug designation requests within the next 90 days, acting on CAHC’s call for “streamlining and speeding up the process to bring more generic and brand drugs to market.”
CAHC President Joel White issued the following statement on FDA Commissioner Gottlieb’s announcement:
“We are pleased to see the FDA moving forward on consensus-driven solutions and taking decisive action to speed approval of new medications while addressing inefficiencies that have plagued the agency for too long. Now, we need Congress to do its part by reforming outdated laws that inhibit value-based arrangements and providing added flexibility for benefit designs, among other reforms,” said CAHC President Joel White. “With our Prescriptions for Affordabilityinitiative, we have provided Congress and the Administration with a roadmap to lower drug costs for all Americans – one that is already endorsed by drug manufacturers, pharmacy benefit managers, employers, patient groups, and other stakeholders oftentimes at opposite ends of the healthcare debates. The diversity of our support is a testament to the substance of our solutions. We look forward to working with policymakers to put these recommendations into action and to deliver results for patients and consumers.”
About the Council for Affordable Health Coverage
The Council for Affordable Health Coverage (CAHC) is a broad-based alliance with a primary focus: bringing down the cost of health care for all Americans. CAHC promotes policies that lower health costs through increased competition, informed consumers and more choices to help promote access to affordable coverage.