MassBio CEO & President Kendalle Burlin O’Connell posted the following statement in response to original reporting from The Wall Street Journal regarding plans by the White House to remove FDA Commissioner Marty Makary from his position:
FDA leadership instability has become a significant and ongoing concern for the Massachusetts life sciences community, and today’s news regarding Commissioner Makary is the latest example of the uncertainty facing the industry. For more than a year, companies working to deliver breakthrough therapies to patients have been operating amid shifting regulatory signals, the loss of experienced scientific staff, and continued turnover in key leadership positions, including the prolonged vacancy at CBER, making long-term planning and investment decisions increasingly difficult.
MassBio has consistently emphasized to lawmakers and administration officials that the FDA needs stable, science-driven leadership alongside modernization efforts that ensure the United States remains competitive with China and other countries investing aggressively in next-generation medicines. Sustained scientific expertise, regulatory predictability, and an efficient review framework are essential not only to maintaining U.S. leadership in biotechnology, but also to ensuring patients can access innovative new therapies as quickly and safely as possible.
In the meantime, MassBio remains focused on supporting our more than 1,700 member companies as they navigate this evolving environment. We stand ready to work constructively with current and future FDA leadership, including the next Commissioner and a permanent CBER director, to help strengthen the regulatory ecosystem, advance innovation and reinforce the United States’ position as the global leader in life sciences.