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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.
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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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UN report reveals alarming rise in Africa's food insecurity despite global improvements
UN report reveals alarming rise in Africa's food insecurity despite global improvements

Winnipeg Free Press

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  • Winnipeg Free Press

UN report reveals alarming rise in Africa's food insecurity despite global improvements

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B.C. government plans to cut payments for long-COVID clinics, leaving patients in the lurch
B.C. government plans to cut payments for long-COVID clinics, leaving patients in the lurch

Vancouver Sun

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  • Vancouver Sun

B.C. government plans to cut payments for long-COVID clinics, leaving patients in the lurch

A virtual clinic that treats patients for long COVID and other chronic conditions is warning that it may have to partially shut down if the province goes ahead with changes on Sept. 1 that would limit the number of patients who can take part in online group appointments. The B.C. Centre for Long COVID, ME/CFS & Fibromyalgia, run by internal medicine specialists doctors Ric Arseneau and R. Jane McKay, treats 5,000 patients for a variety of chronic diseases, such as myalgic encephalomyelitis, which causes extreme fatigue, and PoTS, a heart rate condition. After each patient goes through an initial one-on-one consultation, followup appointments can take the form of a virtual group medical visit of up to 12 patients, where either Arseneau or McKay take at least one to two questions per patient, or a group medication visit of up to 50 patients, which allows for presentations on different medications and then takes questions from patients. Start your day with a roundup of B.C.-focused news and opinion. By signing up you consent to receive the above newsletter from Postmedia Network Inc. A welcome email is on its way. If you don't see it, please check your junk folder. The next issue of Sunrise will soon be in your inbox. Please try again Interested in more newsletters? Browse here. Following the larger group sessions, patients can request prescriptions by email, which are then reviewed by one of the two physicians, according to the clinic's website. But in a June 27 letter to patients, Arseneau stated that he may have to 'abandon our clinic model' starting Sept. 1, due to upcoming changes to B.C.'s medical services plan that would limit to 20 the number of patients per group medical visit that the clinic could charge for. The letter said the changes could shift the burden for these patients' care back on to the primary health-care system and raise overall costs for the system. It also said there are few other specialized facilities capable of treating these chronic conditions and the ones that do exist already have long waiting lists. 'The result is that we will need to abandon our group-based clinic model. MSP's unwillingness to discuss the fate of our already underserviced patients results in our moving forward with a plan we were hoping to avoid,' the letter said. 'We will need to return most of your care to your primary care provider (if you have one). We will no longer be able to prescribe and provide prescription renewals through group medication visits.' In a statement, the Health Ministry said the province is tightening the rules around group telehealth appointments to ensure patients are getting one-on-one attention from a physician. During COVID-19, the limits on the number of people that could be packed into each appointment had been raised due to the inability for doctors to see patients in-person. 'Following the pandemic, the Ministry of Health and Doctors of B.C. established a collaborative virtual care working group to evaluate and recommend permanent updates to virtual care delivery. The ministry has recently begun implementing some of the approved rule changes related to group medical visits,' the statement said. 'These changes were developed in consultation and agreement with the Doctors of B.C. to ensure that requirements of group medical visits are adhered to, including the requirement for a one-to-one interaction between the physician and the patient.' According to the Medical Services Plan's payment schedule, a doctor can currently charge $7.32 a person for a half-hour telehealth group medical visit, meaning the total cost to the province for a half-hour appointment with 50 patients would be $366. An hour-long appointment would cost $732. The clinic declined an interview request. A spokesperson said they still plan to appeal to the province. 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'I think the traditional one-patient, one-physician model, and, preferably, face-to-face model is the way to go. I think you get the best information for diagnostic purposes, and from a patient perspective, you get individualized care,' said Sin. 'If you have a dental issue, would you like to go and sit in front of a group of people with dental cavities or would you like to see the dentist one-on-one?'

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