Lauren Gardner
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FDA politics & policy reporter @POLITICO. Honorary 🇨🇦. 26.2 x5. It's pronounced "wooder." RTs ≠ ;) lgardner@politico.com and on Signal @ gardnerlm.01
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Articles by Lauren Gardner
Overton's FDA chief bid faces skeptical senators
JURY'S OUT — Heidi Overton , President Donald Trump 's pick to lead the Food and Drug Administration, appeared to satisfy none of the senators whose support is essential for her nomination to reach the chamber floor during Thursday's confirmation hearing. But don't count her out yet. Your host caught up with two of the Health Committee Republicans who hold the keys to Overton's fate after the hearing, and neither would divulge how they're leaning. Maine Sen.
Overton skirts senators' questions on abortion pill
The FDA commissioner nominee said an ongoing agency safety review would determine any regulatory changes. FDA commissioner nominee Heidi Overton walked a fine line Thursday responding to senators' questions about how she'd regulate medication abortion if confirmed, irritating Republicans and Democrats alike and complicating her path to confirmation. “According to FDA standards, the drug is safe and effective as labeled today,” Overton told Sen.
FDA nominee contradicts Trump on safety of measles vaccine
Heidi Overton told senators the measles vaccine was “not lethal.” Trump last month said it was. Heidi Overton, the White House's nominee to lead the Food and Drug Administration, told senators Thursday that the measles, mumps and rubella vaccine “is not lethal,” contradicting President Donald Trump's recent statements about the shot.
Inside Congress Live
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Senate Republicans are discussing whether to call up a data center utility costs bill as they make plans to stay in Washington next week rather than beat an early exit before the midterms. Two GOP aides who spoke on the condition of anonymity said the Senate will remain in town amid pressure from some corners of the party to send members home early to campaign.
By Josh Siegel Verified, Jordain Carney Verified, Lauren Gardner Verified, Calen Razor Verified, Kelsey Brugger Verified
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POLITICO
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Trump's latest FDA nominee faces Senate panel deciding her fate
Heidi Overton is a domestic policy adviser for the White House. Heidi Overton, President Donald Trump's pick to run the Food and Drug Administration, will face senators today who are eager to put her stances on abortion policy and vaccines on the record.
FDA panel puts Grail's cancer screening to the test
THE HOLY GRAIL — A panel of outside advisers will vote this week on whether to recommend that the Food and Drug Administration grant the first domestic premarket approval for a multicancer early-detection blood test. California-based biotech Grail, which has spent the last decade studying how to use run-of-the-mill blood work to enable widespread cancer screening, applied in January for FDA signoff on its Galleri diagnostic test for people 50 and older.
Trump's FDA pick gains steam among GOP senators
OVERTON THE HILL — Heidi Overton, President Donald Trump 's pick to be the next FDA commissioner, began meeting with Senate Republicans this week ahead of her confirmation hearing Thursday before the Health Committee “She understands the hope patients and families have for new treatments, from cancer and rare diseases to the next breakthrough for Alzheimer's,” Kansas Sen. Roger Marshall posted Tuesday on social media platform X along with a picture of their meeting.
Klomp to face Dem ire over drug-pricing deals
LET'S MAKE A DEAL — Expect Democrats to use Chris Klomp 's nomination hearing today to serve as Robert F. Kennedy Jr. 's No. 2 at the Department of Health and Human Services to spar over President Donald Trump 's drug-price deals , POLITICO's Carmen Paun reports. Trump has touted Klomp's success in getting major pharma companies to make deals with his administration to lower drug prices and to invest more in U.S. manufacturing as evidence of the Utah native's prowess as a negotiator.
Psychedelics are on the FDA's mind
The FDA is focusing more attention than usual on psychedelics this month as the prospect of the first agency approval for the drug class gets closer. GETTING PSYCHED — The agency will hold a public hearing on the potential future therapeutic use of psychedelic drugs on Monday. Regulators seek comment on several issues pertaining to their use in supervised settings, including patient safety, access considerations, data-collection best practices and provider training and credentialing.
One state's abortion ruling could affect all 50
RULING COULD UPEND STATE LAWS — Louisiana will argue before a federal appeals court today that FDA rules allowing telehealth prescription and mail delivery of the abortion drug mifepristone infringe on the state's right to prohibit the procedure within its borders, Alice reports.
FDA: Foreign clinical trials must generate high-quality data
A group of top FDA officials is cautioning that despite the globalization of clinical trials, it is critical that companies continue to enroll American patients. ENROLL AMERICANS IN TRIALS — The top regulators said that while there are benefits to expanding clinical trials worldwide, overseas trials can create new challenges — including risks to data integrity, transparency and oversight.
Trump touts new most-favored-nation deals
A bevy of nine drugmakers made the trek to the White House on Monday for a now-familiar event with President MIDSIZED DRUGMAKERS VISIT WH — Donald Trump.
The questions facing FDA pick Heidi Overton
PROGRAMMING NOTE: This newsletter will be taking a beach break next week. We'll be back to our normal schedule on Tuesday, Sept. 1. With Carmen Paun WHAT'S THE OVERTON/UNDER? President Donald Trump 's announcement this week of White House aide Heidi Overton as his pick to lead the FDA gave the pharma world something to chew on ahead of the pre-Labor Day dog days of Washington summer — though not many answers to industry's biggest questions.
Trump picks ‘good soldier' to lead FDA despite MAHA, industry misgivings
Senate Health, Education, Labor and Pensions Committee Chair Bill Cassidy has already signaled her vaccine policy work may cost her his vote.
Trump to select Heidi Overton for FDA commissioner
President Donald Trump will nominate White House official Heidi Overton to be the next commissioner of the Food and Drug Administration, according to two people familiar with the pick granted anonymity to discuss the selection. Overton has served as Trump's deputy assistant for domestic policy with a focus on health policy since he reentered office last year.
Trump to select Heidi Overton for FDA commissioner
The agency has been under acting leadership since May. The FDA has not had a Senate-confirmed leader since Marty Makary resigned earlier this year. | Jacquelyn Martin/AP 08/18/2026 08:53 PM EDT President Donald Trump will nominate White House official Heidi Overton to be the next commissioner of the Food and Drug Administration, according to two people familiar with the pick granted anonymity to discuss the selection.
The great MMR divide
With Rachel Bluth SPLITTING UP? When announcing his latest executive order on vaccines Monday, President Donald Trump seized on the section urging manufacturers to break up the combination measles, mumps and rubella vaccine — which he called, without evidence, “quite lethal” — into three separate shots. “What I've heard is that there are some people that say it is that way, and I say, ‘Well, let's say there's a 5 percent chance of it, let's split it up,'” Trump said.
For months, the administration laid low on vaccines. On Monday, Trump went there. Original
Earlier this year, the White House tried to tamp down Kennedy's appetite for vaccine overhauls. President Donald Trump, left, and Health and Human Services Secretary Robert F. Kennedy Jr. in the Oval Office before Trump signs an executive order about vaccines, on Monday, Aug. 10, 2026. | AP Photo/Jacquelyn Martin 08/11/2026 06:19 PM EDT The White House has for months sought to push Health Secretary Robert F.
A window into TrumpRx's demand
With Amanda Chu CHECKING IN ON TRUMPRX — Buried in a Securities and Exchange Commission filing is a glimpse into how a major TrumpRx partner views the financial impact of the effort to connect Americans with lower-cost drugs. GoodRx, which has certain discounts integrated into TrumpRx.gov , said in a 10-Q filing published Wednesday that initial demand is concentrated in weight loss drugs. But the overall effect of the program appears to be limited.
FDA's Moderna flu shot call
ALL EYES ON FLU — The FDA's deadline to decide on Moderna's seasonal flu vaccine application is Wednesday — a major federal health agency milestone ahead of the midterms. Moderna is seeking full approval for the vaccine's use in 50- to 64-year-olds and accelerated approval for individuals 65 and older, with a post-marketing study requirement for the latter group.
Replimune gets a favorable vote after Capricor falls short
REPLIMUNE GETS A WIN — The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 Thursday in favor of the clinical benefit of Replimune's investigational treatment for advanced melanoma, Lauren reports, a day after reaching the opposite conclusion for a separate therapy.
FDA panel to consider previously spurned drugs
A RARE REDO — An FDA advisory committee will hold two days of meetings this week to review applications for novel therapies disfavored by political appointees who have since left the agency. The Cellular, Tissue and Gene Therapy Advisory Committee will review Capricor's deramiocel to treat heart issues in Duchenne muscular dystrophy patients on Wednesday. Thursday will focus on Replimune's twice-rejected immunotherapy for advanced melanoma.
RFK Jr. promised to stop the ‘aggressive suppression' of these controversial drugs. He's making progress. Original
A panel of FDA advisers voted this week to broaden access to peptides. Health Secretary Robert F. Kennedy Jr.'s advisory panel on peptides includes several new permanent members who would benefit from loosened restrictions. | Anna Moneymaker/Getty Images 07/24/2026 02:00 PM EDT Robert F. Kennedy Jr. swears by them. Make America Healthy Again influencers say they can do everything from heal torn tendons to help drop dress sizes.
FDA advisers endorse legal path for peptides
PEP IN THE STEP — Outside advisers to the FDA voted Thursday in favor of creating a legal pathway for four peptides popular with wellness influencers and longevity clinics, despite FDA employees' warnings of limited data showing safety or efficacy, Lauren writes.
Pallone scrutinizes FDA staffing ahead of user fee negotiations
The top Democrat on the House Energy and Commerce Committee wants the Government Accountability Office to examine the impact of the Department of Government Efficiency's cuts on Food and Drug Administration staffing and use of industry user fees.
The unapproved but very online weight-loss drug
With help from Amanda Chu ARE YOU RETA FOR IT? If you cultivate your social media algorithm just right, you can find myriad websites where retatrutide — Eli Lilly's next-generation, investigational weight-loss drug — is just a few clicks away from being delivered to your door.
Another antiviral on the horizon for Ebola?
POTENTIAL EBOLA TREATMENT — An experimental antiviral therapy secured government approvals this week for compassionate use in Uganda, clearing the way for its administration there later this year amid a growing outbreak of a rare form of Ebola for which there are no approved treatments. Galidesivir acts broadly across the family of viruses to which Ebola and Marburg belong, David Foster , CEO of Island Pharmaceuticals, told POLITICO.
FDA's regulatory outlook
REG AGENDA DROPS — ICYMI, the Trump administration's 2026 regulatory agenda quietly published over the long weekend, with plenty of pharma-related items for industry and advocates of various stripes to mull over. Here are the anticipated FDA efforts that caught your host's eye, as well as items at other agencies that might interest RxP readers. Keep in mind the deadlines are targets that routinely slip. If I missed anything you think warrants scrutiny, drop me a line.
FDA unveils peptides position
PEPTIDES UNDER THE MICROSCOPE — The new roster of the FDA's advisory panel on drug compounding contains several members who would benefit from the agency endorsing broader use of peptides and other alternative wellness treatments, Lauren writes. The advisory panel helps give non-binding advice to the FDA on compounding, a practice where a pharmacy or facility alters a drug to meet the needs of an individual patient.
HHS wants to boost American clinical trial research
The Trump administration on Monday unveiled a multi-pronged effort to bolster the United States' early clinical trial ecosystem — an effort nicknamed Operation Trialblazer that HHS Secretary Robert F. Kennedy Jr. said will help return early medical research to America. BOOSTING CLINICAL TRIALS — In recent years, a growing share of early-stage clinical research has been conducted abroad.
FDA allows Colorado drug imports, in theory
THIS TIME WILL BE DIFFERENT? The FDA gave Colorado the green light Monday for its plan to import prescription drugs from Canada, making it the second state to win the agency's authorization for such a program. Still, the FDA decision begs the question: Will this actually work in practice? Colorado Gov. Jared Polis is bullish.
A new sunscreen on the horizon
The FDA is expected to approve a chemical-based sunscreen for the first time. | Kazuhiro Nogi/AFP via Getty Images DAY IN THE SUN — The FDA could sign off on a new chemical sunscreen filter as soon as this week, Lauren writes, a development that doctors and industry alike say could help steer more consumers toward the sun-protection products.
Pharma, patients seek clarity on new vouchers
A public FDA meeting united both critics and boosters of its Commissioner's National Priority Voucher pilot program on one point: Make the criteria clear. | Andrew Harnik/AP Photo ‘PRIORITY’ FOR WHOM? Drug industry representatives and patient and consumer advocates testifying to FDA officials Thursday agreed on one aspect of the agency’s controversial review program for so-called “national” priorities: Leaders need to be clearer about which drugs are eligible and how they’ll be chosen.
A&T Well and Pump Marks 20 Years Serving Raleigh-Area Well Systems
A&T Well and Pump Raleigh, North Carolina A&T Well and Pump Truck in Raleigh, NC A&T Well and Pump, a Raleigh-based well service company, is marking 20 years in business, reflecting continued demand for well repair and well pump replacement. RALEIGH, NC, UNITED STATES, June 3, 2026 /EINPresswire.com/ -- A&T Well and Pump, a Raleigh-based well service company, is marking 20 years in business, reflecting continued demand for well repair and well pump replacement across the region.
House, Senate set up FDA funding action
The effort to fund the FDA for the next fiscal year continues to march forward this week in both chambers of Congress. FDA APPROPS WEEK — The House Rules Committee is slated to meet today at 4 p.m. to set up a rule for a slate of bills that includes fiscal 2027 funding for the Food and Drug Administration. House Majority Leader Steve Scalise 's (R-La.) weekly schedule states the legislation will be considered later this week pursuant to a rule.
FDA panel lays out new Covid vaccine formulation recommendation
With help from Robert King The Food and Drug Administration's outside advisers met to discuss recommending updates to the Covid-19 vaccine. | REUTERS COVID STRAIN SELECTION — The FDA’s outside vaccine advisers overwhelmingly recommended Thursday that the agency direct manufacturers to base their 2026-2027 formulas on the dominant XFG Covid variant.
FDA panel to consider Covid shot update
An FDA advisory committee is expected to recommend which strain of Covid-19 should be included in next season's vaccine. | Paul White/AP Photo COVID SHOTS ON DECK — The FDA’s outside vaccine advisers plan to convene Thursday to recommend which Covid-19 strain vaccine manufacturers should target for the 2026-2027 season’s products, all while the country’s vaccine infrastructure remains in flux.
The search for a Bundibugyo Ebola vaccine
With help from Carmen Paun and Robert King The World Health Organization is working to review and align research for vaccines, drugs and diagnostics for the strain. | Fabrice Coffrini/AFP via Getty Images THE SEARCH FOR A BUNDIBUGYO SHOT — The Ebola outbreak in central Africa sparked by the rare Bundibugyo strain, for which no vaccines or therapies are licensed, has triggered urgency to get a shot in the pipeline, Carmen writes.
What Ebola and hantavirus are revealing about America’s public health system Original
That mistrust could be particularly pronounced within President Donald Trump’s base, including some Make America Healthy Again supporters who embraced the so-called medical freedom movement during Covid.
Pharma’s legal assault on Medicare negotiations hits a SCOTUS wall Original
“This is a strong signal from the Supreme Court that constitutional arguments are not going to cut it” on the topic, he added. To date, the Centers for Medicare and Medicaid Services has completed two negotiation cycles spanning 25 drugs, saving seniors and the government billions of dollars. Democrats, who passed the law during the Biden administration, say they eventually plan to expand the list of drugs eligible for Medicare price negotiation.
SCOTUS rejects pharma suits over Medicare talks
The Supreme Court declined to hear drugmakers' petitions against Medicare drug-pricing negotiations. | Scott Olson/Getty Images MEDICARE DRUG TALKS WIN — The Supreme Court on Monday delivered a major blow to the drug industry’s effort to undercut the constitutionality of Medicare’s price negotiation program, a signature Biden administration achievement that President Donald Trump’s Health Department has continued to implement.
FDA shake-up: Makary loyalists in limbo
With help from Simon J. Levien The FDA's White Oak campus in Silver Springs, Maryland, is abuzz with speculation over who will follow former FDA Commissioner Marty Makary out the door. | Andrew Harnik/AP Photo SHELVED — FDA staffers are buzzing about who in former FDA Commissioner Marty Makary’s orbit will be next to leave the agency.
RFK Jr.’s looming vaccine decisions to test White House midterm strategy Original
Meanwhile, the secretary continues to doggedly pursue research efforts to look for a connection between vaccines and autism, chronic conditions and other ailments, despite scientific evidence to the contrary.. Kennedy allies in the anti-vaccine movement expect him to hold the line. “I know you can never change his heart on this,” said Del Bigtree, who worked on Kennedy’s 2024 presidential campaign.
Makary’s time atop FDA over, Diamantas named acting commissioner
9 hours ago Shortly after Inauguration Day in 2025, Planet Money visited Little Village, a predominantly Mexican-American neighborhood in Chicago. It felt oddly quiet for what was usually a bustling part of the city, almost like a ghost town. The Trump administration had signaled it was about to do big ICE raids …
Makary’s time atop FDA over, Diamantas named acting commissioner Original
The decision to move on from Makary was months in the making, according to a senior administration official granted anonymity to discuss the Johns Hopkins surgeon’s tenure. His stint was marked by mass layoffs, persistent churn among senior leaders and policy fights with lawmakers, drugmakers and President Donald Trump. The administration official said that while the White House had to sign off on the decision, HHS Secretary Robert F. Kennedy Jr. made the call.
Makary in limbo — with a packed schedule
Despite rumors of his impending dismissal, FDA Commissioner Marty Makary has a busy schedule this week. | Francis Chung/POLITICO SIGNS OF LIFE? Washington spent much of Monday waiting for smoke signals to emerge from the White House to lend clarity on FDA Commissioner Marty Makary’s future. Instead, silence from the West Wing left the embattled agency chief room to signal he is still on the job — for now.
More cigarette alternatives ahead, hints regulator
SMOKE SIGNALS — The FDA's top tobacco regulator on Wednesday suggested the agency's recent authorizations of the first fruit-flavored vapes may not be its last move to expand access to lower-risk alternatives to combustible tobacco products.
FDA urged to update safety labels on antidepressants
An FDA official told a group of MAHA supporters that about five citizen petitions are urging the agency to update the labels of SSRIs, like Prozac, with a stronger warning about their side effects. | Darron Cummings/AP Photo SSRI SCRUTINY — An FDA official told a room of Make America Healthy Again supporters Monday that the agency needs data to make any changes to psychiatric drug labels after hours of testimony about patient experiences with adverse reactions they attribute to the medicines.
FDA moves to limit compounding of GLP-1s
The FDA says there's no need for outsourcing facilities to produce compounded versions of branded weight-loss drugs, such as Wegovy and Zepbound. | JoNel Aleccia/AP Photo FDA: NO ‘BULK’ GLP-1S — The FDA proposed Thursday not adding three active ingredients in weight-loss drugs to its so-called bulks list, which allows large compounding facilities to make knockoff versions of branded products in bulk. It’s a major setback for an industry that’s allied itself with Health Secretary Robert F.
FDA’s ‘America First’ approach to user fee talks
With help from Marcia Brown and Sophie Gardner FDA Commissioner Marty Makary has told his teams to use an "America First" approach when negotiating user fees. | Andrew Harnik/Getty Images TAKING STOCK OF USER FEE TALKS — Look no further than the FDA’s negotiations with drug and medical device firms over the next iteration of user fee programs to find evidence of the Trump administration’s “America First” approach to governing.
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