Dr. Marty Makary sets sights on speeding up FDA drug approvals

The U.S. Food and Drug Administration (FDA) has made several recent announcements and updates regarding drug approvals and safety alerts. On March 28, 2025, the FDA published new educational videos to assist rare disease drug developers by emphasizing the importance of endpoints in clinical trials. Alongside this, a Blue Box update was issued concerning a safety alert on contaminated Korean oysters. The agency also celebrated the 15th anniversary of the Biologics Price Competition and Innovation Act (BPCIA), which aims to provide greater access to biological products, recognizing its role in promoting innovation and competition in healthcare. On the same day, the FDA approved Cabometyx, a medication intended for patients aged 12 and over with specific types of neuroendocrine tumors. This approval aims to enhance treatment options for patients facing rare and challenging medical conditions. Additionally, the FDA published a consumer update on pulse oximeters to educate the public on the safe and accurate use of this increasingly common health monitoring device. Dr. Marty Makary, a former surgeon and professor at Johns Hopkins, has recently been confirmed to lead the FDA. During his confirmation hearing, he outlined his vision for the agency, focusing on expediting the drug approval process to bring more cures and meaningful treatments to the public. He criticized the existing FDA procedures as outdated and burdensome, claiming they often lead to significant delays in drug approvals. He highlighted the potential role of artificial intelligence in streamlining regulatory processes and proposed leveraging AI-driven alternatives to traditional clinical trials. Dr. Makary acknowledged the improvements made during the Trump administration, particularly citing efforts made under the 21st Century Cures Act of 2016, which attempted to address the slow approval times that often stretch beyond a decade. He emphasized the need to maintain momentum for reform, aiming to reduce the timeline for drug approval significantly. His vision includes not only accelerating new drug introductions but also ensuring that the approval process for generic and biosimilar drugs is efficient. By fostering competition, he believes it is possible to tackle high drug prices and prevent shortages, which has become a pressing issue in the U.S.