Latest news with #Tidmarsh
Politico
2 days ago
- Health
- Politico
Makary ally named to key FDA drug post
With help from Robert King Driving the Day CDER'S NEW LEADER — Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty Makary's pick to be the nation's top drug regulator. The new Center for Drug Evaluation and Research director has a history with Makary as a contributor to the Journal of the Academy of Public Health, an alternative journal the FDA chief helped launch. Additionally, Tidmarsh spoke at FDA headquarters during Makary's inaugural roundtable discussion on agency-regulated products, praising him for convening the unconventional event so quickly into his tenure. 'You're a person of action, and you care about the public, based on your question and making this a public event,' Tidmarsh said. The former Horizon Pharma founder helped develop the rheumatoid arthritis treatment Duexis — a combination of ibuprofen and the histamine blocker famotidine. He also founded Threshold Pharmaceuticals and was a senior employee at Coulter Pharmaceutical and SEQUUS Pharmaceuticals, according to a Stanford Medicine bio. Already at White Oak: Tidmarsh was on the FDA campus Monday for his first day. 'The number one thing I need to work on is motivating people,' Tidmarsh said in an FDA podcast posted Monday afternoon. 'That's the one thing that is most important coming here.' Tidmarsh also laid out his personal views on the FDA's role in regulating emerging technologies like gene therapies. 'In larger populations, of course, you need to demand the strong, irrefutable data of statistical and clinical significance,' Tidmarsh said. 'But there's going to be times where judgment has to come into play, especially for very small populations.' The Association for Accessible Medicines and the Biosimilars Council quickly praised the pick. 'We look forward to a collaborative partnership with Dr. Tidmarsh and the larger team at CDER to prioritize regulatory efficiency and help ensure the medicines that cost less and make up 90 percent of all prescriptions filled in the U.S. are always available for patients,' AAM CEO John Murphy said in a statement. One thing to keep an eye on is how Tidmarsh fits into an agency that has seen a number of top longtime regulators depart in the past year. 'Tidmarsh's industry background should nevertheless be reassuring to sponsors, though it may be something of a double-edged sword for him as he fits into the broader Trump administration dynamics,' TD Cowen's Rick Weissenstein wrote in a research note. IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your host has been hit hard by a nasty cold he hears is circulating on Capitol Hill. Send tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA FDA V. SAREPTA — The FDA and Sarepta Therapeutics were at odds over the agency's request that the company halt shipments of its Duchenne muscular dystrophy gene therapy, Elevidys. But late Monday, the company agreed to temporarily pause at the close of business on Tuesday. Late Friday, the company put out a news release that said it 'received an informal request' to 'voluntarily halt shipment' of the medicine. 'Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship ELEVIDYS to the ambulant population,' Sarepta said in the release. But Sarepta took a different tack Monday. 'As a patient-centric organization, the decision to voluntarily and temporarily pause shipments of ELEVIDYS was a painful one, as individuals with Duchenne are losing muscle daily and in need of disease-modifying options,' Sarepta CEO Doug Ingram said in a news release. 'It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the ELEVIDYS label supplement process.' Before the announcement by Sarepta, HHS spokesperson Andrew Nixon said the FDA was 'deeply disappointed' in the drugmaker's decision Friday. 'We are deeply troubled that the company insists on dosing additional patients with Elevidys while we investigate this concerning safety signal,' Nixon said in an email. 'FDA will remain flexible but will move swiftly when a product presents an unreasonable and significant risk and will leverage our full regulatory authority to pursue a course of action that protects patients.' LOOMER GOES AFTER PRASAD — Right-wing activist Laura Loomer is taking aim at top FDA vaccine regulator Dr. Vinay Prasad. A Sunday post on Loomer's website points to a litany of remarks Prasad made before he joined the agency earlier this year — arguing he is not aligned with President Donald Trump's agenda. 'Allowing a trojan horse wield such power is a mistake that threatens the very reforms Trump was elected to deliver,' Loomer wrote. 'The time to act is now — Prasad must go before he completely destroys the [Make America Healthy Again] movement and all of the hard work President Trump has put into his regulatory reform agenda.' HHS spokesperson Andrew Nixon declined to comment on the Loomer remarks. Loomer has previously targeted other influential health policy figures she sees as disloyal to Trump. In May, she called out Brian Blase, president of Paragon Health Institute, for his positions on Medicaid. Industry Intel COMING TO A TOWN NEAR YOU — U.K. pharma giant AstraZeneca announced plans to build a new, multibillion-dollar plant in Virginia to manufacture weight-loss drugs, chronic disease medicines and other drug therapies, Robert reports. The announcement on Monday in Washington is part of a larger $50 billion investment from the drugmaker to boost manufacturing and research within the country. The move comes amid threats from President Donald Trump to hit pharmaceutical companies with steep tariffs if they do not take steps to manufacture products in the U.S. 'The U.S. leads innovation in pharmaceuticals, but China is moving very quickly … and we need to continue moving as quickly as we can in the U.S. to keep this leadership,' said CEO Pascal Soriot during the event. The exact plant location remains unclear but once completed would be the 'largest single manufacturing investment in the world,' according to a release from the manufacturer. It would produce GLP-1 weight-loss drugs as well as a combination of small-molecule drugs, the company said. AstraZeneca has also pledged to expand its research and development facility in Gaithersburg, Maryland, as well as new sites to supply clinical trials. Soriot acknowledged that the potential of pharmaceutical tariffs is 'accelerating the movements, whether with us or others.' However, he added that he understood the need for a country like the U.S. to want to see products, medicines serving patients in this country to be manufactured in the country. It's a question of national security.' AROUND THE AGENCIES HEARING THEM OUT — NIH Director Jay Bhattacharya met Monday with 38 staffers who had signed an open letter to him last month, addressing their concerns about grant terminations, staff firings and the politicization of science since President Donald Trump took office, Erin reports. At a rally after the meeting, staffers who attended the roundtable described it as cordial but said Bhattacharya made no promises to reverse agency policy. Bhattacharya welcomed 'open, constructive input' on NIH's future, according to HHS spokesperson Andrew Nixon. 'The ability to question, challenge and share ideas is central to the scientific method,' he added. During the meeting, Bhattacharya said he wouldn't retaliate against NIH staffers for signing the so-called Bethesda Declaration, the name the agency employees used for the letter. The open letter was modeled after the Great Barrington Declaration, which Bhattacharya co-authored in 2020 to protest pandemic lockdowns. Hundreds of NIH staffers from every institute and center signed it, as did Nobel laureates, former NIH institute and program directors and other leaders in the scientific community. Earlier this month, the Environmental Protection Agency placed 139 employees on administrative leave for writing an open letter criticizing EPA Administrator Lee Zeldin for regulatory rollbacks, funding cuts and staff firings at the agency. What's next: Bhattacharya expressed openness about future roundtables, attendees said, but no meetings have been scheduled. Pharma Moves Sonja Fulmer, acting director of the FDA's Digital Health Center of Excellence within the Center for Devices and Radiological Health, is leaving the agency, according to an FDA employee and a former FDA employee granted anonymity to discuss the departure, POLITICO's Ruth Reader reports. Fulmer, who has been at CDRH for more than 10 years, took over for former DHCoE Director Troy Tazbaz after he left in January. HHS did not immediately return a request for comment. Document Drawer The FDA released draft guidance on the International Council for Harmonisation's guidelines for including pregnant and breastfeeding women in clinical trials. FDA Commissioner Marty Makary and agency chief of staff Jim Traficant met with Arnold Ventures to discuss 'items of mutual interest' on July 8, according to a newly posted public calendar disclosure. Makary also met with Sen. James Lankford (R-Okla.) the same day for an introductory meeting. On July 10, Makary met with Rep. Jamie Raskin (D-Md.) for an introductory meeting. WHAT WE'RE READING The New York Times' Sarah Kliff reports on health insurers denying more and more drug claims. The Congressional Budget Office said cuts to the NIH and the FDA would slow drug approval and development, POLITICO's Simon Levien reports.
Yahoo
3 days ago
- Health
- Yahoo
FDA names former pharmaceutical company executive to oversee US drug program
WASHINGTON (AP) — 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.
Los Angeles Times
3 days ago
- 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
3 days ago
- 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."
3 days ago
- Health
FDA names former pharmaceutical company executive to oversee US drug program
WASHINGTON -- 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 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.
