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
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.
Regeneron wins gene therapy nod, signs MFN pact
With help from Robert King President Donald Trump signed an executive order to lower drug prices last May, and since then, 17 major drugmakers have signed on to his most-favored-nation deal. | Jim Watson/AFP via Getty Images ANOTHER MFN DEAL — The final major drugmaker President Donald Trump had pressed to accept a most-favored-nation deal has signed an agreement with the administration, bringing the number of participating firms to 17.
Mark Cuban is moving on from Kamala Harris Original
Harris signaled earlier this month she’s seriously considering entering the 2028 Democratic field. “Listen, I might, I might. I’m thinking about it,” Harris told the Rev. Al Sharpton at the National Action Network convention in New York. Cuban, a Harris surrogate during the last campaign cycle, said he’s not trying to promote a specific candidate now. “I’m trying to change how fucked up this health care industry is right now, and that’s all I care about,” he said.
Psychedelic drugs get the FDA fast-track
With help from Amanda Chu, Amanda Friedman, Simon J. Levien and Alice Miranda Ollstein FDA Commissioner Marty Makary, center, flanked by NIH Director Jay Bhattacharya, left, and HHS Secretary Robert F. Kennedy Jr., discusses the potential benefits of psychedelic therapies. | Julia Demaree Nikhinson/AP Photo A PSYCHEDELICS ‘BREAKTHROUGH’?
What's in an IV bag?
MAHA MEETS IV BAGS — More than a year has passed since HHS Secretary Robert F. Kennedy Jr. took office and swept the Make America Healthy Again agenda into center stage. That movement has caught the attention of a ubiquitous corner of the medical device industry that has long pressed states and the federal government to pursue regulations and laws that would restrict the use of a chemical in IV bags that it says harms developmental and reproductive health. B.
New poll reveals a country divided on vaccines
GROWING VACCINE DOUBT — The POLITICO Poll made a stark finding last month in a survey of more than 3,800 Americans about a variety of health issues: Vaccine skepticism is widespread among adults, your morning host reports. The March poll, conducted by Public First, suggests that one of Health Secretary Robert F. Kennedy Jr.’s long-held views is more commonplace in the U.S. than perhaps once thought.
More Americans doubt vaccine safety than trust it, POLITICO Poll finds
More Americans doubt vaccine safety than trust it, POLITICO Poll finds Politico April 14, 2026 By Lauren Gardner Health Secretary Robert F. Kennedy Jr.’s views are commonplace across the land. Vaccine skepticism among Americans is widespread, The POLITICO Poll found, indicating that one of Health Secretary Robert F. Kennedy Jr.’s animating priorities is gaining traction.
More Americans doubt vaccine safety than trust it, POLITICO Poll finds Original
Nearly half of U.S. adults surveyed last month signaled they think the science on vaccines remains up for debate and that it’s damaging to require people to receive them, rather than that the science is clear and it is dangerous to challenge it. A clear partisan divide exists among vaccine skeptics. Six in 10 Republicans surveyed favored administering fewer vaccines, compared to three in 10 Democrats.
RFK Jr. revamps vaccine panel charter
UNCHARTERED TERRITORY — Health Secretary Robert F. Kennedy Jr. has signed an updated charter document for the CDC's vaccine advisory panel that underscores its role in considering vaccine safety risks and broadens membership qualifications to include areas that could invite skeptics on board, Lauren and POLITICO's Sophie Gardner report. The Advisory Committee on Immunization Practices' charter, which guides its mission and makeup, is supposed to be renewed every two years on April 1.
RFK Jr. amends guidelines for key vaccine panel
A federal judge put the Advisory Committee on Immunization Practices on ice last month. The changes could help Kennedy find a way around that decision.
Top drug lobbyist to depart PhRMA at year end Original
A pharmaceutical industry consultant granted anonymity to discuss the news said it was disclosed at a PhRMA board call Wednesday morning that was scheduled on Monday evening. “There was an unplanned board call for Steve where he talked about staying on until the end of the year, but this will be his last year as CEO,” the pharmaceutical industry consultant said. “No successor was mentioned.” The announcement caps roughly a decade for Ubi atop the powerful brand drug lobby.
FDA seeks more power over drug ads, advisory panels
FDA Commissioner Marty Makary's budget proposal for fiscal 2027 requests more control over advisory committees. | Drew Angerer/AFP via Getty Images BUDGET NUGGETS — The Trump administration dropped its fiscal 2027 budget request Friday, and the massive document release includes some notable legislative proposals for the FDA as the White House looks to build on the Make America Healthy Again agenda heading into the midterms.
Trump’s pharma tariffs: Big hits, bigger loopholes
With help from Alice Miranda Ollstein President Donald Trump's tariff plan targets mostly brand names but spares generics and rare-disease treatments. | Evan Vucci/AP TARIFF DAY — The Trump administration unveiled its plan to place tariffs on imported drugs Thursday. The caveat? There are a lot of exemptions.
Gilead accused of blocking global access to HIV drug
Doctors Without Borders is urging Gilead to sell its HIV prevention drug directly to them to broaden its global access, but so far the drugmaker isn't cooperating. | Karel Prinsloo/AP Photo HIV DRUG STANDOFF — Pharmaceutical company Gilead Sciences has refused to directly sell its HIV prevention drug lenacapavir to Doctors Without Borders for use in its worldwide efforts to combat the disease, the global humanitarian group said.
MAHA fans want action Trump hasn’t delivered
Nearly 70 percent of those who support HHS Secretary Robert F. Kennedy Jr.'s MAHA movement think regulators like the FDA don't act in the public interest, according to a new POLITICO poll. | Alex Wong/Getty Images PHARMA ON MY MIND — A supermajority of American adults favor challenging big pharmaceutical companies, according to a new POLITICO poll, but they’re closely divided on which political party is up to the task.
HHS could face a vaccine injury lawsuit
HHS Secretary Robert F. Kennedy Jr.'s agency is being threatened with a lawsuit if its vaccine injury program doesn't update the list of injuries associated with vaccinations. | George Walker IV/AP Photo THE NEXT VICP FRONTIER? A longtime legal ally of Health Secretary Robert F.
Kennedy’s latest MAHA-approved plan could supercharge peptide boom Original
Kennedy didn’t specify what the FDA will do, referring vaguely to “some kind of new action” after the agency reviews the science around the peptides in question. But there are other signs that new regulations are likely afoot. Last summer, a group of compounding pharmacies that had sued the FDA over its restrictive peptide stance agreed to stand down when the agency said it “expects to submit” a final rule by next February addressing four peptides the companies want to produce.
FDA to seek public input on drug-priority program
FDA Commissioner Marty Makary is touting his newly established program to speed up FDA approvals of certain drugs.
Judge pauses Kennedy’s vaccine panel purge
With help from Alice Miranda Ollstein and Amanda Chu A court has put the brakes on HHS Secretary Robert F. Kennedy Jr.'s overhaul of the CDC's vaccine advisory panel. | Michael M. Santiago/Getty Images ACIP ON ICE — A Biden-appointed federal judge issued a ruling Monday to temporarily suspend most of Health Secretary Robert F.
Federal judge puts RFK Jr.’s new vaccine schedule, advisers on ice
Now Ruling on a lawsuit brought by several prominent medical organizations, a district court said the federal government had not based its decisions on science in limiting Covid shots and revising the childhood immunization schedule. In a severe blow to the Trump administration’s health agenda, a federal …
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