Marty Makary, the commissioner of the Food and Drug Administration, has completed his first 100 days in charge of the agency with a flurry of media appearances and a series of bold announcements. While some of these announcements show promise, others pose a risk to the FDA’s established practices and could potentially undermine the agency’s effectiveness.
One particularly positive idea put forth by Makary is the proposal to make complete response letters (CRLs) public. These letters are sent to companies when their medicines are rejected by the FDA, providing valuable insight into the reasons for the rejection. By making this information public, Makary hopes to increase transparency and accountability within the agency.
However, some of Makary’s other announcements have raised concerns about the potential impact on the FDA’s operations. It is important to balance the need for innovation and efficiency with the need to uphold the rigorous standards that have made the FDA a trusted regulatory body.
In order to maintain the FDA’s reputation for thoroughness and reliability, Makary must ensure that any changes he implements are thoughtfully considered and carefully executed. While it is important to explore new ideas and approaches, it is essential to preserve the integrity and effectiveness of the FDA’s regulatory processes.
As Makary continues to lead the FDA, it will be crucial for him to strike a balance between fostering innovation and upholding the agency’s core principles. By doing so, he can ensure that the FDA remains a trusted and effective regulator of the U.S. economy.
