Latest news with #drugregulation
The Independent
21-07-2025
- Health
- The Independent
FDA names former pharmaceutical company executive to oversee US drug program
The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency's drug program, the latest in a string of leadership changes at the agency. FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency's Center for Drug Evaluation and Research, which regulates the safety and effectiveness of all U.S. drugs. His appointment comes a month after the center's acting director, Dr. Jacqueline Corrigan-Curay, announced her retirement. As the agency's top drug regulator, Tidmarsh will be charged with following through on a number of commitments made by Makary and his boss, Health Secretary Robert F. Kennedy Jr., including reviewing the safety of the abortion pill mifepristone. The FDA is also scrutinizing certain uses of other long-established drugs, including antidepressants and hormone-replacement drugs for menopause. Tidmarsh founded and led several pharmaceutical companies, including Horizon Pharmaceuticals, maker of an anti-inflammatory medication for arthritis. He has also served as an adjunct professor at Stanford University. The FDA's drug center is the agency's largest unit, with nearly 6,000 staffers responsible for reviewing the safety and effectiveness of new drugs and monitoring the use and marketing of older drugs. About 2,000 FDA staffers have been laid off as part of widescale cuts to the federal health workforce overseen by Kennedy. More than 1,000 others have taken buyouts or early retirement, while many others are reportedly searching for new jobs. The departures have threatened basic FDA operations, including the timely review of new drugs. FDA's drug center hasn't had a permanent director since January, when Dr. Patrizia Cavazzoni stepped down days before President Donald Trump took office. Nearly all of the FDA's senior leadership positions have turned over in recent months, either due to retirements, resignations or actions by administration officials placing them on administrative leave. FDA center directors typically hold their positions for years or even decades, serving across multiple administrations, whether Republican or Democrat. In May, Makary named Dr. Vinay Prasad, a prominent critic of the FDA's COVID response, to run the agency's vaccine center. He was also named to the post of FDA chief medical officer. Prasad joined the agency after his predecessor, longtime vaccine chief Dr. Peter Marks, was forced out in March. The head of FDA's tobacco center was also forced to step down in April. A permanent replacement has not yet been named. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Zawya
21-07-2025
- Business
- Zawya
FDA to appoint George Tidmarsh as top drug regulator
U.S. Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the director of the Center for Drug Evaluation and Research, Bloomberg News reported on Monday, citing a person familiar with the decision. Tidmarsh's appointment as the agency's top drug regulator could be announced as soon as Monday, the report said, citing the person who asked not to be identified. Jacqueline Corrigan-Curay, the acting head of the division, recently announced she was leaving the agency, according to the report. The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment. Tidmarsh also did not immediately respond to email and LinkedIn requests for comment. Tidmarsh, a Stanford University-affiliated pediatrician, will oversee one of the FDA's largest and most important divisions, which regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. In May, he took part in an FDA expert panel to discuss the safety and necessity of talc as an additive in food, drug and cosmetic products. "It's not if talc should be removed from the U.S. market. It's a matter of how and when. It's a dangerous substance. We have safer, more modern low cost alternatives," Tidmarsh had then said. He previously served as the chief executive officer of Horizon Pharma — a company he founded in 2005. While at Horizon, he led all aspects of development of Duexis, which was approved by the FDA for the treatment of rheumatoid arthritis. Tidmarsh also held senior positions at other biotechs such as SEQUUS Pharmaceuticals and Coulter Pharmaceutical. He retired from Revelation Biosciences' board in May. (Reporting by Sriparna Roy and Sneha S K in Bengaluru; Editing by Shilpi Majumdar)
Reuters
21-07-2025
- Health
- Reuters
FDA to appoint George Tidmarsh as top drug regulator, Bloomberg News reports
July 21 (Reuters) - U.S. Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the director of the Center for Drug Evaluation and Research, Bloomberg News reported on Monday, citing a person familiar with the decision. Tidmarsh's appointment as the agency's top drug regulator could be announced as soon as Monday, the report said, citing the person who asked not to be identified. The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment. Tidmarsh also did not immediately respond to email and LinkedIn requests for comment.
South China Morning Post
30-06-2025
- Health
- South China Morning Post
New drug approval system takes Hong Kong closer to biomedical hub goal
Hong Kong has good reason to aspire to its own internationally recognised regime for approving pharmaceutical drugs . Intense global demand for Covid-19 vaccines remains fresh in the memory. The city also happens to rank No 2, behind only New York, as a market for biomedical and pharmaceutical companies to raise capital. To realise this goal, developing independent clinical trial capacity and a regulatory framework comparable with the US Food and Drug Administration would go a long way. It would also raise Hong Kong's standing as a medical innovation hub. Advertisement It is therefore good to hear from health authorities that the city will begin reviewing and approving drugs independently in phases from 2026. A new regulatory system is set to begin operating by the end of next year, with more new medications expected to hit the local market before long. To clear the way, the Department of Health has unveiled a plan to set up a centre for the regulation of medical products, with the aim of becoming a recognised international drug regulation authority. This is the final link in a road map for the development of primary drug evaluation, an approach foreshadowed in Chief Executive John Lee Ka-chiu's 2023 policy address. This will speed up product reviews. Primary evaluation means approving drugs based on their clinical trial data, without relying on registration approval from other regulatory authorities. A preparatory office for the centre was set up in June last year to study and plan for a drug regulatory regime. The department said primary evaluation was expected to be implemented gradually over five years. To that end, Hong Kong recently opened its first clinical trial institute , located in a cross-border tech zone. The development of Hong Kong as a biomedical hub not only means business opportunities for the city, but resonates with vast market potential on the mainland, where people cannot always afford new drugs approved in the US. As a rapidly ageing society, Hong Kong has a multipronged interest in recognition as an Asian pharmaceutical and biomedical hub with big potential for healthcare shaped by biotech and bioscience. Advertisement
South China Morning Post
26-06-2025
- Health
- South China Morning Post
Hong Kong to begin independent drug review, approval in late 2026
Hong Kong will start reviewing and approving drugs independently in phases when the city's regulatory agency begins operation as early as the end of next year, health authorities have announced, as more new medications are expected to hit the city's market. The Department of Health on Thursday revealed its plan to set up its drug regulatory authority as part of the city's ambition to become an international hub for health and medical innovation. The Hong Kong Centre for the Medical Products Regulation, aimed to be a leading international regulatory authority, is slated to be established by the end of 2026. 'With next year's phased implementation of the primary evaluation approach, we hope that there will be more new drugs entering Hong Kong's market,' Director of Health Dr Ronald Lam Man-kin said. Hong Kong first raised its plan to establish an agency to approve drugs on a 'primary evaluation' approach in Chief Executive John Lee Ka-chiu's 2023 policy address. Primary evaluation means approving drugs based on their clinical trial data, without relying on registration approval from other regulatory authorities.
