Latest news with #CDER
Los Angeles Times
21-07-2025
- Business
- Los Angeles Times
FDA Appoints Biotech Executive as Top Drug Regulator Under RFK Jr.
Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency's top drug regulator, the agency confirmed Monday. Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University, will serve as director of the Center for Drug Evaluation and Research, one of the FDA's largest and most important divisions with a staff of about 5,700 that reviews the vast majority of new drug applications. Jacqueline Corrigan-Curay, the acting head of the CDER, recently announced she was leaving the agency. Tidmarsh, 65, was involved in the development of several approved drugs, likely making him a reassuring choice for a pharmaceutical industry that's facing pressure from the Trump administration to lower prices and move manufacturing to the US. Tidmarsh's appointment 'brings in a generally well-respected, credible industry veteran, we believe helping fill a key regulatory void,' Brian Abrahams, an analyst at RBC Capital Markets, said in a note to clients. While recent cuts at the agency have raised concerns about the FDA's drug approval process, 'we would expect Tidmarsh to be a pragmatic officer who will likely build upon current practice to ensure continuity and potentially be an advocate for the industry.' Among the controversies Tidmarsh will contend with is the agency's accelerated approval process. The use of this expedited pathway to get drugs green lit has skyrocketed in recent years and been criticized for sometimes letting unproven treatments linger on the market for too long. Advocates say speeding up the process gets drugs quickly to patients suffering from serious diseases. Tidmarsh is also primed to be a key player in reassessing the agency's approach to regulating prescription drug advertising. Health Secretary Robert F. Kennedy Jr. has long been a critic of direct-to-consumer drug advertising, and Makary has indicated that the agency is reviewing its approach to regulating such ads. During a panel on censorship and scientific speech at Stanford last year, Tidmarsh raised concerns about the FDA's inconsistent regulation of pharmaceutical products. He pointed to the agency's long-standing restrictions on off-label communication by manufacturers and questioned some vaccine makers' ads during the pandemic.'This discrepancy shows that FDA may apply free speech regulation at a whim and inconsistently,' he said. While the FDA's vaccine division has been in the spotlight recently over Covid shots, the drug division has made some of the agency's most controversial decisions. In the '90s, CDER approved language allowing opioid drugs, such as OxyContin, to be widely marketed — despite a lack of substantial evidence supporting their long-term effectiveness. The move helped pave the way for the opioid epidemic. The division also caused a firestorm after approving the Alzheimer's treatment Aduhelm that hadn't clearly been proven to work in research studies. On a recent podcast, Tidmarsh said he met Makary at a conference last fall at Stanford. It featured many people critical of restrictions and mandates during the pandemic, several of whom now have top government health jobs. Tidmarsh appears to share Makary's concerns about a lack of dissenting viewpoints in science. In a podcast about a year ago, he said academics foster a culture that is reluctant to question prevailing views and that grantmaking has become concentrated into a few hands. On LinkedIn last year, Tidmarsh wrote that 'academic science has become riddled with fraud, the time has come to root out the corruption.' He funds the Sleuth in Residence program that supports scientific fraud investigators at the website Retraction Watch, which tracks academic journals. At Stanford, Tidmarsh got both his medical degree and a PhD in cancer biology and then worked in the school's clinical faculty. He also had a series of biotech jobs, including chief executive officer for La Jolla Pharmaceutical Co., which developed a drug to treat sepsis and is now part of Innoviva Inc. Tidmarsh, who was also trained in pediatric oncology, has worked over the years to find solutions to shortages of old lifesaving cancer drugs. In an interview last year with a publication for doctors, he likened the US generic drug market to a 'wild west' where predatory contracting practices can drive out manufacturers. Langreth and Hornblower write for Bloomberg.
CNBC
21-07-2025
- Health
- CNBC
FDA taps biotech industry veteran as RFK Jr.'s top drug regulator
The Food and Drug Administration said on Monday it has appointed former biotech executive George Tidmarsh as the agency's top drug regulator. Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University's School of Medicine, Fpauswill lead one of the biggest and most crucial divisions of the FDA, which reviews the vast majority of new drug applications. The Center for Drug Evaluation and Research, or CDER, regulates over-the-counter and prescription treatments, including biologic therapies and generics. The acting head of CDER, Jacqueline Corrigan-Curay, announced in June she was retiring. Tidmarsh will step in as the FDA and its regulatory process face massive upheaval under Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy has pursued deep staff cuts across HHS and, in some cases, brought in new employees who either lack relevant scientific and medical experience or share his skepticism of vaccines. But Tidmarsh's extensive background in the industry and involvement in the development of seven now-approved drugs is likely a sigh of relief for the pharmaceutical industry. His previous comments signal that he could take a more hardline approach to regulating drugs. In an opinion piece in April, Tidmarsh slammed regulatory decisions made by a key official pushed out of the FDA under Kennedy, Peter Marks. That includes supporting the accelerated approval of Biogen's ill-fated Alzheimer's drug, Aduhelm, and overruling FDA staff to expand approval of Sarepta Therapeutics' Duchenne muscular dystrophy treatment Elevidys. Last week, the FDA asked Sarepta Therapeutics to halt all shipments of Elevidys after three patients died from liver failure after taking it or a similar treatment. The company later said it would not stop shipments to treat patients with the condition who can still walk, saying data show "no new or changed safety signals" within that group. Tidmarsh will likely have a say on that controversial accelerated approval process and the FDA's approach to prescription drug advertising. He served as CEO of La Jolla Pharmaceuticals and Horizon Pharma, the latter of which he founded before Amgen bought it for $28 billion. Tidmarsh also founded Threshold Pharmaceutical, and held senior positions at other biotech companies. "Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside," said FDA Commissioner Dr. Marty Makary, in a statement. "His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency."
Reuters
21-07-2025
- Health
- Reuters
FDA appoints George Tidmarsh as top drug regulator
July 21 (Reuters) - U.S. Food and Drug Administration commissioner Marty Makary has appointed former biotech executive George Tidmarsh as the director of the Center for Drug Evaluation and Research, the health regulator said on Monday.
Associated Press
19-05-2025
- Health
- Associated Press
PMC's FDA Report Shows Continued Progress for Personalized Medicine
Washington, D.C., May 19, 2025 (GLOBE NEWSWIRE) -- The Personalized Medicine Coalition (PMC) has released a new report documenting the U.S. Food and Drug Administration's approval last year of 18 new personalized medicines. The agency also approved six new gene and cell-based therapies for rare genetic diseases and some cancers and approved or cleared new or expanded indications for 11 diagnostic testing systems. 'The new personalized medicine approvals and policy developments at the FDA in 2024 helps demonstrate that scientific innovation continues to move the health system away from one-size-fits-all, trial-and-error medicine, toward the utilization of molecular information to improve patient outcomes and make clinical care more efficient,' says PMC President Daryl Pritchard. The annual report, Personalized Medicine at FDA: The Scope & Significance of Progress in 2024, also highlighted several regulatory developments in the field of personalized medicine. Other 2024 achievements include: • expanded indications for previously authorized personalized therapies, including the first ever for an approved gene therapy treatment • safety label changes for certain cancer treatments based on pharmacogenomic (PGx)-based biomarker testing • release of a draft guidance document on Diversity Action Plans to improve enrollment of participants from underrepresented populations in clinical studies • establishment of the Center for Drug Evaluation and Research (CDER) Artificial Intelligence (AI) Council to provide oversight, coordination and consolidation of CDER activities around AI use • creation of the CDER Center for Real-World Evidence Innovation to coordinate, advance and promote the use of real-world evidence in regulatory decision-making • establishment of the Rare Disease Innovation Hub to enhance collaboration across the FDA for rare disease product development 'The newly approved products, and these important regulatory milestones, will help innovators and clinicians provide safer and more efficacious treatments and prevention regimens based on the principles of patient-centered care,' the report reads. The scope of breakthroughs underscored the acceleration of the personalized medicine field. The 2024 approval of 18 personalized medicines – meaning the label references specific biological markers – represent approximately 38 percent of all newly approved therapeutic molecular entities. Treatment areas include: cancer, Alzheimer's disease, cystic fibrosis, Niemann-Pick disease and alopecia. Personalized medicines now account for at least a quarter of drug approvals for each of the last 10 years. That's a notable increase from a decade ago when such treatments made up less than 10 percent of new therapies that were approved. 'We can't take progress for granted, however,' says Pritchard. 'The FDA should continue to promote policies and practices that push forward the field so we can realize the true potential of personalized medicine.' ### About the Personalized Medicine Coalition: The Personalized Medicine Coalition is a nonprofit education and advocacy organization comprised of more than 200 institutions from across the health care spectrum, including innovators, scientists, patients, providers and payers. PMC works closely with business executives, clinicians, lawmakers and government agency officials to promote the understanding and adoption of personalized medicine concepts, services and products. For more information, please visit Kayla Brown Personalized Medicine Coalition [email protected]
Al Bawaba
08-05-2025
- Health
- Al Bawaba
FDA and OpenAI to collaborate on AI drug evaluation
Published May 8th, 2025 - 09:29 GMT ALBAWABA - The Food and Drug Administration (FDA), which is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, the food supply, cosmetics, and radiation-emitting products, has announced plans to collaborate with OpenAI, the American artificial intelligence research organization, to evaluate drugs and medications using AI. Also Read Apple, Google to sign Artificial Intelligence partnership FDA collaborates with OpenAI The FDA plans to collaborate with OpenAI with the aim of accelerating the drug development and evaluation process. The project, cderGPT, is an artificial intelligence (AI) tool developed by the Center for Drug Evaluation and Research (CDER), which regulates prescription and over-the-counter drugs in the United States. Notably, partners from Elon Musk's Drug Evaluation and Quality (DOGE) Center were also reportedly involved in the discussions. The project, cderGPT, is an artificial intelligence (AI) tool developed by the Center for Drug Evaluation and Research (CDER), which regulates prescription and over-the-counter drugs in the United States. (Shutterstock) As artificial intelligence (AI) becomes increasingly integrated into all aspects of our lives, the FDA and OpenAI aim to accelerate drug development and evaluation in the United States (US) and globally. Artificial Intelligence (AI) has the potential to streamline the drug development process, making it faster and more efficient. However, experts are raising concerns about the reliability and oversight of artificial intelligence (AI) models, particularly in high-stakes areas such as medicine. © 2000 - 2025 Al Bawaba (
