KEEPING YOUR EYE ON THE TRUTH CAN BE A DIFFERENCE BETWEEN BEING IN $CAPR INSTEAD OF OUT OF A LONG POSITION.
President-elect Donald Trump has nominated Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, to lead the U.S. Food and Drug Administration (FDA). Dr. Makary is known for his criticism of certain public health measures during the COVID-19 pandemic and has advocated for reducing bureaucratic obstacles within federal health agencies.
Dr. Makary’s approach to the FDA’s drug approval process emphasizes streamlining procedures to expedite the availability of treatments for serious conditions, such as Duchenne Muscular Dystrophy (DMD). He has expressed concerns about the agency’s “cozy relationship” with drug manufacturers and has criticized specific FDA decisions, including the approval of certain COVID-19 vaccines and Alzheimer’s treatments.
The FDA has recently approved several treatments for DMD, including:
• Elevidys (delandistrogene moxeparvovec): A gene therapy approved in June 2023 for pediatric patients aged 4 through 5 years with a confirmed mutation in the DMD gene.
• Duvyzat (givinostat): An oral medication approved in March 2024 for the treatment of DMD in patients six years and older, representing the first nonsteroidal drug approved for all genetic variants of DMD.
Dr. Makary’s potential leadership could influence the FDA’s approach to approving such treatments. While his intent to reduce bureaucratic delays may accelerate the availability of new therapies, his critical stance on certain FDA decisions suggests he may implement more stringent evaluation processes to ensure drug efficacy and safety.
In summary, Dr. Makary’s nomination indicates a potential shift in the FDA’s drug approval process, aiming to balance expedited access to treatments for diseases like DMD with rigorous scientific evaluation to maintain public trust and safety.
How Science Meets A.I.
KEEPING YOUR EYE ON THE TRUTH CAN BE A DIFFERENCE BETWEEN BEING IN $CAPR INSTEAD OF OUT OF A LONG POSITION.
President-elect Donald Trump has nominated Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, to lead the U.S. Food and Drug Administration (FDA). Dr. Makary is known for his criticism of certain public health measures during the COVID-19 pandemic and has advocated for reducing bureaucratic obstacles within federal health agencies.
Dr. Makary’s approach to the FDA’s drug approval process emphasizes streamlining procedures to expedite the availability of treatments for serious conditions, such as Duchenne Muscular Dystrophy (DMD). He has expressed concerns about the agency’s “cozy relationship” with drug manufacturers and has criticized specific FDA decisions, including the approval of certain COVID-19 vaccines and Alzheimer’s treatments.
The FDA has recently approved several treatments for DMD, including:
• Elevidys (delandistrogene moxeparvovec): A gene therapy approved in June 2023 for pediatric patients aged 4 through 5 years with a confirmed mutation in the DMD gene.
• Duvyzat (givinostat): An oral medication approved in March 2024 for the treatment of DMD in patients six years and older, representing the first nonsteroidal drug approved for all genetic variants of DMD.
Dr. Makary’s potential leadership could influence the FDA’s approach to approving such treatments. While his intent to reduce bureaucratic delays may accelerate the availability of new therapies, his critical stance on certain FDA decisions suggests he may implement more stringent evaluation processes to ensure drug efficacy and safety.
In summary, Dr. Makary’s nomination indicates a potential shift in the FDA’s drug approval process, aiming to balance expedited access to treatments for diseases like DMD with rigorous scientific evaluation to maintain public trust and safety.