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FDA names former pharmaceutical company executive to oversee US drug program

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.
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Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW251, a Novel Glypican 3-Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate
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COVID rising in California. How bad will this summer be?
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time35 minutes ago

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COVID rising in California. How bad will this summer be?

COVID-19 is once again on the rise in California. It remains to be seen whether this latest uptick foreshadows the sort of misery seen last year — when the state was walloped by its worst summertime surge since 2022 — or proves fleeting. But officials and experts say it's nevertheless a reminder of the seasonal potency of the still-circulating virus. 'We definitely are seeing an uptick in the summer,' Dr. Erica Pan, director of the California Department of Public Health and the state health officer, said during a recent webinar. As has often been the case with COVID, the latest increase in infections is not playing out uniformly across the state. The uptick was first registered in Northern California and only started being seen in Southern California more recently. 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The California Department of Public Health recommends that everyone age 6 months and up 'should have access and the choice to receive currently authorized COVID-19 vaccines, with an emphasis on protecting higher-risk individuals, such as infants and toddlers, pregnant individuals and others with risks for serious disease,' Pan said. That's stronger than the latest federal guidance, which reflects recent recommendations issued by the Trump administration. The Trump administration dropped the recommendation that healthy children and healthy pregnant women be vaccinated for COVID-19. In formal documents, health officials offer 'no guidance' as to whether pregnant women should get the vaccine, and ask that parents talk with a healthcare provider before getting the vaccine for their children. 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A number of health groups, including the American Academy of Pediatrics and American Public Health Assn., have sued Kennedy in federal court, alleging he violated federal law by changing COVID-19 vaccine recommendations without scientific evidence. In California, an estimated 37% of seniors have received at least one dose of the latest version of the COVID-19 vaccine, which was released in September. The rate is around 50% for much of the San Francisco Bay Area. Senior vaccine coverage is roughly 40% in San Diego, Ventura, Santa Barbara and Sacramento counties, and around 30% in Los Angeles, Orange, Riverside and San Bernardino counties. 'Insurance coverage for COVID-19 vaccines is still in place,' Pan said. A number of medical professional and scientific organizations are aligning to support scientific-based vaccine recommendations, Pan said, including the American Academy of Pediatrics, the American Medical Assn. and AHIP, an association of health insurance plans. Alarmed at the Trump administration's changes around vaccine policy, the Center for Infectious Disease Research and Policy at the University of Minnesota has launched a 'vaccine integrity project,' which aims 'to make recommendations for how vaccine use can remain grounded in the best available science, free from external influence,' according to a university statement. California health officials are also warning that the proposed federal budget threatens to cut deep into public health. The federal government is proposing to halve the budget for the CDC, Pan said this month, from $9.2 billion to $4.3 billion. About 80% of the CDC's funding goes to state and local health agencies, Pan said. Nearly half of the budget for the California Department of Public Health comes from the federal government, and about two-thirds of the state's public health department budget is given to local health agencies. The proposed federal budget would eliminate key centers and programs, such as the National Center for Chronic Disease Prevention and Health Promotion, as well as grants for hospital preparedness and preventive health and health services, Pan said. The proposal also suggests reducing by more than half funding for public health emergency preparedness, from $735 million to $350 million, Pan said. In June, a COVID-19 immunization grant was not extended to California and expired, according to the state Department of Public Health. 'These federal funding cuts mean everyone in Los Angeles County will be at increased risk for transmitting and contracting infectious diseases,' the L.A. County Department of Public Health said in a statement to The Times. The agency said it not only works to prevent and control infectious diseases, but also inspects more than 57,000 food facilities and restaurants, tests and issues alerts about beach water quality, looks over safety issues at healthcare facilities and responds to public health emergencies, such as the region's recent wildfires. 'The President's proposed budget ... would continue a dismantling of core public health activities and severely reduce funding for federal public health grant programs, including a 55% cut to the CDC, our main source of federal grant funds,' the L.A. County Department of Public Health said. L.A. County could lose more than $200 million in annual public health funding under the budget proposal, the agency added, which would eliminate or significantly cut funding for public health emergency preparedness, chronic disease prevention, vaccination efforts and worker safety programs. Among the concerns is the sudden termination of more than $45 million in previously awarded federal grant funds that support infectious disease control efforts and lab capacity, vaccination campaigns and substance use prevention. A federal court has temporarily paused the Trump administration's efforts to claw back those federal funds, the county said. 'But if we do not win this case, that funding will be abruptly terminated, leading to layoffs of dozens of contract employees, terminated purchase orders, and reductions in funding for [community-based organizations] supported by these funds,' the county said.

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