FDA taps biotech industry veteran as RFK Jr.'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."
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The Hill
2 hours ago
- The Hill
Coke with cane sugar may not be that big of a MAHA victory
Coca-Cola is going to offer a cane sugar version of its signature beverage, rather than one sweetened with corn syrup. Major segments of the food industry, including General Mills and Heinz, have pledged to remove certain colored dyes from their products. The fast-food chain Steak 'n Shake is making french fries in beef tallow rather than vegetable oil. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has claimed them all as significant victories for his 'make America healthy again' (MAHA) movement as part of its quest to reform the U.S. food supply. 'Froot Loops is finally following its nose — toward common sense,' Kennedy said on social platform X after cereal-maker WK Kellogg Co. agreed to remove synthetic dyes from its cereal by 2027. 'I urge more companies to step up and join the movement to Make America Healthy Again.' But nutrition and food policy experts say the moves are a far cry from actually making America healthier. While they praised the administration and MAHA for drawing attention to what they said is a broken food system, the victories touted thus far have been largely symbolic and rely on the goodwill of an industry that is eager to appear helpful to avoid strict government regulation. 'I think if we're really curious about improving public health, some of the small health initiatives, like … replacing high fructose corn syrup with cane sugar, are really not where the administration should be channeling their efforts and leveraging the power that they do have,' said Priya Fielding-Singh, director of policy and programs at the George Washington University Global Food Institute. 'I think they should be focusing their efforts on initiatives that actually address the root of the problem, which is essentially a food system that promotes excess sugar, salt and fat,' Fielding-Singh said. Health officials and GOP lawmakers have taken to conservative media in recent weeks to tout the commitments from food and beverage companies to remove synthetic dyes. According to the HHS, nearly 35 percent of the industry has made such a commitment. But there's been no force behind the companies' actions, which experts said is an issue. 'Simply switching from synthetic to natural colors will not make these products less likely to cause obesity,' said Jerold Mande, a former senior official during three administrations at the Food and Drug Administration (FDA), the Department of Agriculture and the Occupational Safety and Health Administration. Barry Popkin, a nutrition professor at the University of North Carolina Gillings School of Global Public Health, said Kennedy could make a major statement by banning all colors and dyes. It wouldn't directly make Americans healthy, but it would go a long way toward making ultra-processed food look less appealing. 'All this voluntary stuff only goes so far. It really does minimal impact,' Popkin said. 'Unless he goes to the FDA and has the FDA change a regulation … there's nothing.' Kennedy has also singled out the use of high-fructose corn syrup as a major contributor to diabetes and obesity. He has previously called it 'poison,' an epithet he repeated in late April when talking about sugar. When Steak 'n Shake said earlier this month it was going to sell Coca-Cola with real cane sugar, Kennedy praised the move. 'MAHA is winning,' Kennedy posted on X. But experts said there's no substantial difference in the benefits of using cane sugar as a substitute for high-fructose corn syrup. 'At the end of the day, a Coke is still a can of Coke. It's not a fruit or a vegetable, right? And so if you're not shifting consumption away from these higher calorie, lower nutrient processed foods, toward nutrient dense, health promoting foods, then you're not actually going to be shifting the health of Americans in the right direction,' Fielding-Singh said. But if Kennedy thinks sugar is poison, 'they're both sugar and would both be poison, in his words,' said Mande, who is now CEO of Nourish Science. Health officials argue industry cooperation is key to the MAHA agenda. 'Working with industry is the best place to start. And we believe in industry to do the right thing when called upon,' Food and Drug Administration Commissioner Marty Makary and Centers for Medicare and Medicaid Services Administrator Mehmet Oz wrote in a joint op-ed in The Wall Street Journal. 'Our agencies are in a strong position to show Americans which companies are doing the right thing when it comes to popular reforms. By the time we're done, we will have built new relationships and be better positioned to hold them accountable,' Makary and Oz wrote. Yet there is plenty the agency can, and should do, that industry has pushed back against. Aviva Musicus, science director of the nonprofit Center for Science in the Public Interest, said MAHA is wasting its political capital. 'It's striking that we haven't seen the administration use policy to improve the food system. It's solely relying on voluntary industry commitments that we've seen repeatedly fail in the past,' Musicus said. 'In pushing the food industry to change, Trump and RFK Jr. have a chance to live up to their promises to fight chronic disease. Coca-Cola is at the table, but they're wasting the opportunity to actually improve health. The administration should focus on less sugar, not different sugar,' Musicus added. Popkin said he would like to see warning labels on ultra-processed foods high in sodium, added sugar and saturated fat. Kennedy 'hasn't tackled ultra-processed food yet. That'll be where he could make an impact on health in the U.S. and all the non-communicable diseases, including obesity. But he hasn't gone there yet,' Popkin said. The coming months will reveal more on the MAHA movement's plans to change how Americans eat. New dietary guidelines will be released 'in the next several months,' Kennedy said recently. In addition, a second MAHA report focused on policy recommendations is expected in August. 'We have to be considering that there could be real potential down the road,' Popkin said. 'But [there's been] nothing yet. That document will tell us if there ever be.'
The Hill
2 hours ago
- The Hill
The FDA must crack down on dangerous knockoff weight-loss drugs
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Politico
3 hours ago
- Politico
Playbook: A name to remember
Presented by With help from Eli Okun, Bethany Irvine and Ali Bianco Good morning. It's Sunday. This is Zack Stanton. Get in touch. THE CONVERSATION: From restricting food dyes and ultra-processed foods to tackling what he calls the 'child vaping epidemic,' FDA Commissioner Marty Makary wants to 'go bold,' he tells Playbook's Dasha Burns on today's episode of 'The Conversation.' But it's another part of their discussion that may yet prove to be the most consequential if it comes to fruition as government policy: backing research and funding into women's health. 'It does feel like the system just doesn't think specifically about the very particular needs of women's bodies and doesn't do enough research into this,' Makary told Dasha. 'We got hormone replacement therapy [for menopausal and perimenopausal women] wrong for 22 years, scaring women, saying that, you know, 'it increases your risk of dying of breast cancer' when no clinical trial has ever supported that finding,' he said. 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'The expression 'skin and bones' doesn't do it justice,' Nick Maynard, a British surgeon volunteering at the same hospital at which Zainab died, told NYT's Patrick Kingsley and colleagues. He was describing his shock at treating another infant, a skeletal 7-month-old. 'I saw the severity of malnutrition that I would not have thought possible in a civilized world. This is man-made starvation being used as a weapon of war and it will lead to many more deaths unless food and aid is let in immediately.' 'I don't know what you would call it other than mass starvation, and it's man-made, and that's very clear,' World Health Organization chief Tedros Adhanom Ghebreyesus said this week at a press conference, per WaPo. Israeli PM Benjamin Netanyahu's government repudiates that narrative. 'Israel rejects the false accusations of 'starvation' propaganda initiated by Hamas which manipulates pictures of children suffering from terminal diseases,' the Israeli foreign ministry said in a statement last night. 'It is shameful.' But it's an undeniable reality that, for Gazans, hunger has been drastically more widespread since the expiration of a six-week ceasefire in March, after which Israel reimposed a blockade on the territory. 'Beginning in late May, U.N. humanitarian efforts were replaced by the Gaza Humanitarian Foundation, an Israeli- and U.S.-backed aid distribution system,' report WaPo's Ruby Mellen and colleagues. 'Critics have warned that the foundation — which is registered as a nonprofit but is backed by entities hoping to profit from the relief effort — transports inadequate aid to Palestinians under a flawed setup that forces them to risk their lives for provisions.' Since May, Israel has allowed in an average of 69 aid trucks a day, per AP's Wafaa Shurafa and colleagues — 'far below the 500 to 600 trucks a day the U.N. says are needed for Gaza.' Today, at this very moment, we're in a brief 10-hour window during which Israel has paused military operations in parts of Gaza to allow aid into the territory, Reuters' Nidal Al-Mughrabi and colleagues report. After global outcry over the spiraling humanitarian catastrophe, Israel announced this morning that humanitarian pauses will continue on a daily basis until further notice. Key members of Netanyahu's government disagree with that decision. 'This is a capitulation to Hamas' deceitful campaign,' far-right National Security Minister Itamar Ben-Gvir said in a statement. He went on to repeat — in Reuters' words — 'his call to choke off all aid to Gaza, conquer the entire territory and encourage its Palestinian population to leave.' But the international pressure on Netanyahu is mounting. And there are key questions that could change the situation substantially: What, if anything, does President Donald Trump want to do? Will he pressure Israel to come to the table and broker a ceasefire? Trump, who is in Scotland, is due to meet tomorrow with British PM Keir Starmer. Their discussion, per the Telegraph's Dominic Penna, will focus on the U.K.-U.S. trade deal, further support for Ukraine and the urgent need for a ceasefire in Gaza. Pressure is mounting within the U.S., too, as the humanitarian disaster has stirred people across the political spectrum. Growing numbers of Democrats — including staunch defenders of Israel — are speaking out, as POLITICO's Gigi Ewing and Ben Johansen report. And conservative Ross Douthat used his influential Sunday NYT column today to write that 'Israel's warmaking at this moment is unjust.' Aid groups have welcomed the news of Israel's daily 10-hour pause during which they can bring food into the territory — the World Food Program says it has enough food en route to Gaza to feed the entire population for three months, per Haaretz — but broadly believe that a ceasefire is 'likely the only way to end the crisis,' NYT's Aaron Boxerman writes. Today, that 10-hour pause will end at 8 p.m. local time, or 1 p.m. Eastern. By then, perhaps, food will have been distributed and medicine delivered to hospitals. It will have come too late for Zainab Abu Halib. But there still may be time for others. 'I don't know what to say anymore,' her mother told CNN yesterday. 'How many innocent babies like Zainab should be starved to death so the world wakes up?' SUNDAY BEST … — Commerce Secretary Howard Lutnick on the tariff deadline coming up Friday, on 'Fox News Sunday': 'No extensions, no more grace periods. Aug. 1, the tariffs are set. They'll go into place. 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But the desperation is real, NBC's Adam Edelman reports from the National Governors Association summer meeting in Colorado Springs. Hawaii Gov. Josh Green says outright that Republicans are trying to steal the election and Dems must 'fight fire with fire.' 2. RACE FOR THE STATES: Republican operatives in Pennsylvania are in panic mode about another potential Doug Mastriano gubernatorial bid — and whether his down-ballot effect could cost the GOP the House, POLITICO's Holly Otterbein reports. Their fear is that the far-right state senator could again win a primary and again get clobbered by Josh Shapiro, who's now the popular incumbent. State Treasurer Stacy Garrity could be the establishment Republican pick. Some Trump advisers are concerned, and local Republicans hope Trump will endorse Garrity. But Mastriano says that's not true: 'I have President Trump's direct line,' he writes. 'And he ain't saying this.' On the left coast: In California, some Democrats are batting about similar — if much less dire — concerns about a potential Kamala Harris gubernatorial bid, CNN's Isaac Dovere reports. Harris has plenty of enthusiastic allies, but her critics worry that she'll be saddled with Joe Biden-era baggage and motivate Republicans to turn out, damaging Democrats in swing House races. 3. THE LEGACY OF DOGE: At the NGA meeting, HHS Secretary Robert F. Kennedy Jr. offered a rare candid glimpse into the budgetary tensions that may exist within the Trump administration, POLITICO's Shia Kapos writes in. Kennedy acknowledged he's hardly enthusiastic about the cuts being taken to his agency. 'If it were up to me, I wouldn't cut anything in my department,' he told the governors and attendees during the meeting yesterday. 'With the exception of maybe [Education Secretary] Linda McMahon, there's nobody else in the Cabinet who wants to see any of their budgets cut.' McMahon spoke at the conference Friday. The comment earned the biggest laugh of the day — a light moment in a conference that was otherwise focused on serious stuff. Kennedy also talked about chronic disease, healthful school lunches and the mystery of peanut allergies. What he didn't talk about: his take on vaccines. The summer gathering also featured tech billionaire Mark Cuban, who spoke about artificial intelligence, and Mehmet Oz, now the top official at the Centers for Medicare and Medicaid Services, who huddled with governors behind closed doors. Also in the DOGE house: The Department of Government Efficiency is now using an AI tool to rifle through hundreds of thousands of federal regulations — with the goal of cutting half of them outright by determining which rules aren't required by law, WaPo's Hannah Natanson and colleagues scooped. Administration spokespeople say no final decisions have yet been made. 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As Hegseth focused on polygraph tests to root out leakers to the press this spring, the White House ordered his team to stop when Hegseth senior adviser Patrick Weaver (a Stephen Miller ally) told them he was worried about being targeted, WaPo's Dan Lamothe and Ellen Nakashima scooped. And Hegseth has refused to promote Lt. Gen. Douglas Sims — first over suspicion of leaking, of which Sims was cleared, and then over Sims' ties to Mark Milley, NYT's Greg Jaffe and colleagues report. Even an intervention by Joint Chiefs of Staff Chair Gen. Dan 'Razin' Caine couldn't move Hegseth on Sims, who's now likely to retire. 'Mr. Hegseth's actions could shape the military's top ranks for years to come. His insistence on absolute loyalty, backed with repeated threats of polygraphs, also creates uncertainty and mistrust that threaten to undermine the readiness and effectiveness of the force, officials said.' 6. ABOUT THAT QATAR JET: 'What Will It Cost to Renovate the 'Free' Air Force One? Don't Ask,' by NYT's David Sanger and Eric Schmitt: 'Officially, and conveniently, the price tag has been classified. But even by Washington standards, where 'black budgets' are often used as an excuse to avoid revealing the cost of outdated spy satellites and lavish end-of-year parties, the techniques being used to hide the cost of Mr. Trump's pet project are inventive. Which may explain why no one wants to discuss a mysterious, $934 million transfer of funds from one of the Pentagon's most over-budget, out-of-control projects — the modernization of America's aging, ground-based nuclear missiles.' 7. KNIVES OUT FOR PENNY PRITZKER: The leader of Harvard's Corporation and Democratic former Commerce secretary could be targeted for removal by the Trump administration in an eventual deal between Washington and Harvard, NYT's Anemona Hartocollis reports. And on campus, some professors think having Pritzker step down would be a relatively small and painless concession for Harvard to make, since it wouldn't encroach on academic autonomy. But Pritzker would have to choose to step down, and she has plenty of allies in Cambridge. 'Friends said she was unlikely to give in.' 8. BANNED AID: 'Trump administration to destroy birth control intended as aid,' by WaPo's Maham Javaid and colleagues: 'The family-planning supplies, which include more than 50,000 intrauterine devices, nearly 2 million doses of injectable contraceptives, nearly 900,000 implantable contraceptive devices and more than 2 million packets of oral birth control, are worth about $9.7 million … The government of Belgium, the United Nations and humanitarian groups say they tried to stop the destruction of the contraceptives, which they say are needed in much of the developing world.' 9. SUNDAY READ: 'ICE Took Half Their Work Force. What Do They Do Now?' by NYT's Eli Saslow: 'For more than a decade, Glenn Valley [Foods]'s production reports had told a story of steady ascendance — new hires, new manufacturing lines, new sales records for one of the fastest-growing meatpacking companies in the Midwest. But, in a matter of weeks, production had plummeted by almost 70 percent. Most of the work force was gone. Half of the maintenance crew was in the process of being deported, the director of human resources had stopped coming to work, and more than 50 employees were being held at a detention facility in rural Nebraska.' TALK OF THE TOWN LIFESTYLES OF THE RICH AND POWERFUL — 'Diary of a Foreigner in Rome,' by Air Mail's Mattia Ferraresi: 'Tilman Fertitta, the U.S. ambassador to Italy, is yet to move into Villa Taverna, according to Italian-media reports. The sumptuous Roman villa … is rumored to have been deemed a dump uninhabitable by the Texas multi-billionaire, who insists it needs major renovation. He has allegedly taken up residence on Boardwalk, his 250-foot-long yacht sailing under the flag of the Cayman Islands and moored in the port of Civitavecchia, some 60 miles north of Rome. Fertitta's helicopter commute has quickly become the latest buzz in Rome's power circles.' OUT AND ABOUT — SPOTTED in owner Mark Ein's box at the Mubadala Citi DC Open quarterfinals Friday at Carter Barron to watch Frances Tiafoe play Ben Shelton: Rep. Doris Matsui (D-Calif.), Antony Blinken, Steve Ricchetti, Venus Williams, Gerry Baker, Margaret Carlson, Gene Sperling, Sally Ein, Charlie Ein, Chloe Ein, Alli Andresen and Mary Currie. WHITE HOUSE ARRIVAL LOUNGE — Harry Jung is now senior policy adviser at the President's Council of Advisors on Digital Assets. He most recently was acting chief of staff at the Commodity Futures Trading Commission. HAPPY BIRTHDAY: Rep. Glenn 'G.T.' Thompson (R-Pa.) … Sean Savett … Priscilla Painton of Simon & Schuster … Katie Wheelbarger … Alex Wirth of Quorum … Andy Spahn … Paul McLeod … Cecilia Muñoz … retired Adm. Craig Faller … Johanna Persing … Jeremy Adler … Prime Policy Group's Stefan Bailey … John Connell of Sen. Todd Young's (R-Ind.) office … Linda Feldmann … Gaurav Parikh … Bobby Cunningham of the Vogel Group … Live Action's Lila Rose … Bobby Saparow … Jeremy Deutsch of Capitol Venture … Anna McCormack of Rep. David Rouzer's (R-N.C.) office … MSNBC's Denis Horgan … Juan Mejia … former Reps. Dave Brat (R-Va.) and Lacy Clay (D-Mo.) … Ashley Gonzalez … former Commerce Secretary Don Evans … CNN's Susan Durrwachter … former CIA Director John Deutch … Seth Waugh … Kate Thompson of the Russell Group … Air Force's Charlie McKell … Susan Phalen … Nicholas Anastácio of National Journal … Brayden Karpinski … POLITICO's Brian Tran-Dac … Andrew Grossman Send Playbookers tips to playbook@ or text us on Signal here. Playbook couldn't happen without our editor Zack Stanton, deputy Garrett Ross and Playbook Podcast producer Callan Tansill-Suddath.
