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WASHINGTON – A number of industry groups have released statements following the U.S. Senate confirming the nomination of Dr. Martin Makary to serve as the next Commissioner of the U.S. Food and Drug Administration by a recorded vote of 56-44.
Dr. Makary is a British-American surgeon, professor, author, and medical commentator. He practices surgical oncology and gastrointestinal laparoscopic surgery at the Johns Hopkins Hospital, is the Mark Ravitch Chair in Gastrointestinal Surgery at Johns Hopkins School of Medicine, and is the chief of Islet Transplant Surgery at Johns Hopkins.
The Consumer Healthcare Products Association released this statement with quotes from president and CEO Scott Melville:
“CHPA congratulates Dr. Makary on his confirmation by the Senate today as FDA Commissioner. His leadership comes at a pivotal time for public health, with opportunities to advance self-care innovation, safety, and access to trusted over-the-counter (OTC) medicines, dietary supplements, and OTC medical devices.
“CHPA is committed to engaging with Dr. Makary and his team on continued implementation and reauthorization of the Over-the-Counter Monograph User Fee Program (OMUFA), optimizing FDA’s Additional Condition for Nonprescription Use (ACNU) final rule, and modernizing the regulations overseeing dietary supplements. We also hope to continue enhancing the Rx-to-OTC switch process and appreciate Dr. Makary for highlighting its benefits during his remarks in the Senate HELP Committee earlier this month as a pathway to help lower healthcare costs and empower consumers. By collaborating on these key initiatives, we can help safeguard and advance public health with a modern, science-based regulatory framework that benefits consumers and fosters a healthier America.”
The Healthcare Distribution Alliance has released the following statement on the U.S. Senate’s vote to confirm Dr. Marty Makary as the Food and Drug Administration Commissioner:
“HDA congratulates Dr. Makary on his confirmation as FDA Commissioner. As the federal agency tasked with ensuring the safety and effectiveness of pharmaceuticals, the FDA is one of the healthcare distribution industry’s leading regulatory partners. Distributors serve as the logistics experts of the supply chain and work to protect the safety and security of pharmaceuticals for patients and providers across the U.S.
“Currently, a top priority for HDA and our members is bolstering long-term resilience within the pharmaceutical industry to mitigate existing and new drug shortages. To this end, HDA supports federal investments to enhance manufacturing capabilities for pharmaceutical ingredients in the U.S., and we look forward to the opportunity to advance these initiatives.
“To avoid future supply disruptions, it is also critical that the Drug Supply Chain Security Act (DSCSA) is implemented effectively. Distributors have long led compliance efforts surrounding this law and have continuously worked with the FDA to ensure a smooth and effective implementation of its requirements. With final deadlines looming, we will remain in close communication with the FDA.
“HDA and our healthcare distributor members are proud of our longstanding, strong partnership with the FDA and look forward to working with Dr. Makary and his team to maintain a safe and efficient healthcare supply chain for all Americans.”
In a statement, the Association for Accessible Medicines congratulated Dr. Makary on his confirmation as Food and Drug Administration Commissioner:
“AAM and the Biosimilars Council congratulate Dr. Makary on his confirmation by the Senate as FDA Commissioner,” said John Murphy III, President and CEO of AAM. “Ensuring that all Americans have access to safe, effective, and affordable medicines is essential to public health. Generic and biosimilar medicines are the foundation of pharmaceutical cost savings, delivering high-quality treatments while reducing health care expenses. We look forward to collaborating with Dr. Makary and the dedicated team at the FDA to enhance efficiency, modernize regulatory pathways, and strengthen a sustainable, competitive pharmaceutical market that benefits patients nationwide.”
Furthermore, the statement said: “AAM also recognizes the critical role of the FDA’s highly skilled staff in ensuring timely reviews of generic and biosimilar medicines. A fully resourced FDA is essential to maintaining an efficient and science-based regulatory process that supports innovation, ensures drug availability, and prevents delays that could impact patient access to affordable treatments. We stand ready to work with Dr. Makary and Congress to ensure that the FDA has the resources and staffing needed to fulfill its mission and keep life-saving medicines accessible to all Americans.”
