logo
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.
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.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Target Recall Update Issued Nationwide: Customers Urged Not to Eat Products
Target Recall Update Issued Nationwide: Customers Urged Not to Eat Products

Newsweek

time11 minutes ago

  • Newsweek

Target Recall Update Issued Nationwide: Customers Urged Not to Eat Products

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Several products stocked at Target stores nationwide have been recalled due to risks ranging from undeclared allergens to potential contamination with Listeria monocytogenes. YoCrunch Yogurts Several types of YoCrunch Yogurts have been recalled by the company due to the potential presence of plastic pieces in the dome topper, which could be a choking hazard if consumed, the Food and Drug Administration said. Out of the products stocked at Target, the affected types are the YoCrunch Low Fat Vanilla with OREO Yogurt, YoCrunch Low Fat Vanilla with M&Ms Yogurt, YoCrunch Low Fat Strawberry with M&Ms Yogurt, all in 4ct/4oz size cups. Also included are the YoCrunch Low Fat Vanilla with OREO and M&Ms Yogurt Variety Pack with 8ct/6oz size cups. The FDA said that the loose plastic pieces are only at risk of being found in the separately packaged topper, and this does not impact the separately packaged yogurt. It said that the transparent plastic pieces may have sharp edges and are between 7 and 25 mm in length. A Target shopping center storefront pictures on Oxon Hill, Maryland USA June 22, 2024. A Target shopping center storefront pictures on Oxon Hill, Maryland USA June 22, 2024. Getty Images Customers who have purchased the affected products are advised not to consume them, and can contact YoCrunch's consumer care department for information about refunds. The recall was initiated voluntarily by manufacturer Danone U.S. in cooperation with the FDA on July 11. Newsweek contacted Danone U.S. for comment via email on Thursday. RITZ Peanut Butter Cracker Sandwiches RITZ Peanut Butter Cracker Sandwiches have been recalled due to incorrect labeling that may not specify they contain peanuts. In several multi-pack varieties, some individual packs may be incorrectly labeled as the cheese variety even though it may be a peanut butter variety, the FDA notice said. All outer labels on cartons are correct. The recall notice said that the issue was a "supplier error" and that corrective actions are being taken to help ensure this issue does not recur. Out of the products stocked at Target, the recall applies to Ritz Cracker Sandwiches with Peanut Butter in the 8ct/11.04oz size, and Ritz Peanut Butter Cracker Sandwiches Family Size 27.6oz/20ct. Customers with peanut allergies are advised to not eat the products and to discard them. The manufacturer Mondelēz Global LLC announced the voluntary recall on July 8. Mondelēz confirmed that it was conducting a voluntary recall of products in an emailed statement to Newsweek and pointed to their press release for more information. Oscar Mayer Turkey Bacon Oscar Mayer Turkey Bacon in 12oz packages sold at Target are among Kraft Heinz products being recalled byb the company due to risks that they are contaminated with Listeria monocytogenes, the United States Department of Agriculture said. The recalled products have the USDA mark of inspection on them. A contamination was detected through lab testing, and no confirmed illnesses have been reported so far. Listeria infection, or listeriosis, can cause severe illness, especially in older adults, those with weakened immune systems, and pregnant women. Symptoms may include fever, muscle aches, and gastrointestinal issues, with more severe risks such as miscarriage and death for vulnerable groups. The USDA urges consumers not to eat the affected turkey bacon and to either discard it or return it to the store. Kraft Heinz told Newsweek in an emailed statement: "We are also working collaboratively with public health authorities, including the United States Department of Agriculture (USDA), to take the appropriate steps and initiate a recall. We deeply regret this situation and apologize to any consumers we have disappointed."

A drug carrying the FDA's most serious warning recalled by a Florida company
A drug carrying the FDA's most serious warning recalled by a Florida company

Miami Herald

time40 minutes ago

  • Miami Herald

A drug carrying the FDA's most serious warning recalled by a Florida company

A pharmaceutical company based in Naples with research and development division based in Coral Springs recalled a drug for failing an in-house testing of medication degradation. Lupin Pharmaceuticals' Clomipramine Hydrochloride capsules are used 'for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD),' according to the National Library of Medicine. The 2,724 recalled 100-count bottles of 25 mg capsules come from lot No. M300464 with an expiration date of June 2025. Lupin issued no press release for the June 27 recall. READ MORE: The role fake Viagra played in a 70-year-old Miami doctor losing his license Clomipramine also counts as an antidepressant and carries an FDA 'Black Box Warning' or 'Boxed Warning' on the packaging that begins: 'Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of clomipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.' If you experience a medical problem because of this or any other drug, first notify a medical professional. Then tell the FDA via the MedWatch program, either online or by calling 800-332-1088.

COVID-19 Is Rising Again. Here's What to Know
COVID-19 Is Rising Again. Here's What to Know

Time​ Magazine

time41 minutes ago

  • Time​ Magazine

COVID-19 Is Rising Again. Here's What to Know

As much as we want to put it behind us, COVID-19 isn't going away. Cases are currently rising across the country in a summer surge. The U.S. Centers for Disease Control and Prevention (CDC) reports that cases of COVID-19 are increasing in nine states and likely growing in another 16. The trends are estimates, as the CDC no longer conducts rigorous surveillance of cases based on results from lab tests. Fewer people are also getting tested. But the data do provide a hint of how the disease is changing over time, and new monitoring systems that track viruses in wastewater confirm the rise. The CDC says that the overall level of respiratory diseases in the U.S.— COVID-19, flu, and RSV—remains 'very low,' but that emergency room visits for COVID-19 are on the rise, accounting for 0.5% of emergency room visits in the country as of mid July, compared to 0.3% of cases at the beginning of the summer. While that may seem like a small increase, emergency room visits are a bellwether for disease trends, since they represent cases in which people are sick enough to seek care. 'We are starting to hear about more young kids or older adults showing up in the emergency room with COVID-19,' says Dr. Luis Ostrosky, chief of infectious diseases at UT Health Houston. Texas is one of the states seeing spikes in infections. Here's what experts say you need to know about the current surge in cases. Why are COVID-19 cases increasing in the summer? Unlike most respiratory diseases like the common cold and flu, which generally peak during the winter, COVID-19 tends to spike twice and sometimes three times a year: once in the fall and winter, once in spring, and another time in the summer. While viruses tend to spread more easily when people are gathered indoors during cold weather, the post-winter time periods also coincide with 'travel, vacations, and people congregating and going to events,' says Ostrosky. COVID-19 trends also depend on the emergence and spread of new variants. The latest, including NB.1.8.1, are getting better at spreading among people, which contributes to a bump in cases. Read More: What to Do About Your Red, Itchy Eyes Another factor that could be driving the surge in infections is that fewer people are getting vaccinated, for a number of reasons. U.S. health authorities recently changed COVID-19 vaccine recommendations, continuing to recommend yearly shots for older people and those who have weakened immune systems, but allowing otherwise healthy adults more leeway to decide whether to get vaccinated. Many experts, however, continue to encourage people to get them. 'What I tell my colleagues and patients is that we need to follow the evidence, and the best evidence out there is not controversial,' says Ostrosky. 'Vaccines are safe and very effective in preventing severe disease, hospitalizations, mortality, and Long COVID.' It's important for most people to get vaccinated every year to maintain good protection against severe disease, he says, and for those with weaker immune systems, including the elderly, to get vaccinated twice a year. 'I can't tell you how many times I've heard patients ask, 'Do COVID vaccines still work? Am I still supposed to get them?'' With less focus on the vaccines, education and awareness about them is dropping, he says, and that could fuel upticks in cases. Where is COVID-19 rising? According to the latest CDC estimates, the virus is growing in Arkansas, Illinois, Iowa, Kentucky, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. The agency's models find that there is a 95% chance that the epidemic is growing, which means more states could start to see increases in infections. What is the latest dominant COVID-19 variant? Omicron variants still account for all new infections in the U.S., with NB.1.8.1 responsible for 43% of cases as of the end of June. However, the CDC says the low number of cases reported to the agency means the data may not reflect the latest situation. Will the vaccine protect me from COVID-19? The current version of the vaccine targets a different, older Omicron variant, but it remains effective in protecting against severe disease because the viruses are closely related. 'Not only are they all Omicron, but they are from a specific branching of Omicron that is pretty well conserved over the past year and a half,' says Ostrosky. 'So I have pretty good confidence that the vaccine remains a good match for circulating variants.'

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store