STAT+: Drug makers sue HHS over a discount program serving low-income populations
In a clutch of lawsuits, three drug makers argue the federal government is wrong to…
Category: government agencies
Opinion: ICE must provide Covid-19 vaccines to all detained migrants
After months of public health and political debates on vaccine prioritization for incarcerated populations, Covid-19…
STAT+: In a last-minute, intra-agency scuffle, HHS overrules FDA pick for a key position
WASHINGTON — Health secretary Alex Azar suddenly appointed a new top lawyer at the Food…
STAT+: Commerce Department agency proposes eliminating ‘march-in rights’ as a tool to lower drug prices
In a little-noticed move, a Commerce Department unit has proposed a new rule that would…
For people with type 1 diabetes, CDC guidelines for Covid-19 vaccine priority are puzzling
Laura Woerner has diligently managed her type 1 diabetes since she was diagnosed at age…
STAT+: Tennessee to become the first state to run a closed Medicaid drug formulary
In a first-of-its-kind move, the Trump administration will allow Tennessee officials to restrict medicines covered…
STAT+: FDA advisory panel meetings became ‘rarer and tougher’ in 2020
Among the myriad changes wrought by the Covid-19 pandemic, Food and Drug Administration advisory committee…
Opinion: Proposed new rules for a J-1 visa will hinder America’s fight against Covid-19
As Covid-19 infections once again surge across the United States, one of the biggest obstacles…
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STAT+: The health tech tracker for the first quarter: 13 important events to watch
It will be a quarter unlike any other in recent memory for the health tech…
STAT+: 3 freshman lawmakers for health wonks to watch
WASHINGTON — Members of Congress have a habit of contorting their resumes to find a…
STAT+: A former FDA chief, brimming with experience but lacking in niceties, surprises Washington by winning Biden’s trust
WASHINGTON — David Kessler is not the obvious choice for any role in the Biden…
Opinion: Did the FDA understaff its review of the Pfizer/BioNTech vaccine?
In what is arguably the most important decision the Food and Drug Administration has made…
Pfizer decision to turn off temperature sensors forced scramble to ensure Covid-19 vaccines kept ultra-cold
A last-minute snafu this fall threatened to disrupt the smooth rollout of the first Covid-19…
STAT+: State attorneys general urge HHS to penalize drug makers for cutting discounts to hospitals
More than two dozen state attorneys general are urging federal authorities to fine several large…
FDA approves genetically altering pigs, to potentially make food, drugs, and transplants safer
Genetically engineering pigs so they lack a certain sugar on the surface of their cells…
STAT+: Hospital groups sue HHS for failing to stop drug makers from cutting medication discounts
A group of hospital associations filed a lawsuit accusing the Department of Health and Human…
Opinion: India’s drug regulator has failed the pandemic stress test. The U.S. should take notice
The Covid-19 pandemic has served as a stress test for drug regulators across the world….
STAT+: Biden’s HHS pick, Becerra, has taken in more campaign cash from health groups than any other industry
WASHINGTON — Xavier Becerra, President-elect Biden’s pick to lead the Department of Health and Human…
STAT+: Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug
A federal watchdog is being asked to investigate the Food and Drug Administration for an…
STAT+: Families tell U.N. Vertex is violating human rights with cystic fibrosis drug pricing
In an unusual move, a coalition of cystic fibrosis patients and their families have filed…
STAT+: FDA finds fault with a Bristol plant, but it may not upset key approval of a cancer drug
The Food and Drug Administration found problems during a recent inspection of a Bristol Myers…
Opinion: A new rule that protects VA clinicians who practice across state lines should kick off a movement
Amid the pandemonium of a turbulent election and a resurgent virus, the Department of Veterans…
STAT+: A payoff for U.S. taxpayers? CDC may have claims on remdesivir patents held by Gilead
Six years ago, a team of scientists at the Centers for Disease Control and Prevention…
STAT+: FTC says the number of pay-to-delay cases remains low, but vows to keep watch
Although more drug makers are settling patent infringement lawsuits, the U.S. Federal Trade Commission found…
Public health experts are pressuring Biden to include health expertise in his cabinet
Prominent public health experts are pressuring President-elect Biden and his team to include a doctor…
STAT+: FDA spikes a drug approval program that inadvertently led to price hikes and shortages
After years of mounting criticism, the federal government is planning to end a controversial program…
STAT+: Which pricey drugs will Trump’s international pricing policy target?
A version of this story first appeared in D.C. Diagnosis, STAT’s weekly newsletter about the…
Opinion: OSHA’s ‘absurd reinterpretation’ of a regulation regarding workers and Covid-19
Workplace exposures continue to be a major driver of the coronavirus pandemic, something that the…
STAT+: NIH fails to disclose enough details about drug licensing, watchdog report finds
Amid increasing debate over the cost of prescription drugs, a federal watchdog agency found the…
Pfizer, BioNTech to submit formal application to FDA to authorize Covid-19 vaccine
The drug maker Pfizer and its German partner BioNTech said they plan to apply Friday…
STAT+: FDA vows to disclose data used to support emergency drug authorizations
In response to blistering criticism, the Food and Drug Administration committed to publicly disclosing reviews…
STAT Plus: The health tech tracker for the fourth quarter: 14 pivotal industry events to watch
Welcome to STAT’s Health Tech Tracker, a ledger of all the major data readouts, product…
STAT Plus: For two decades, the FDA approval process for opioids had numerous shortcomings, study finds
Over more than two decades, the Food and Drug Administration approved opioid painkillers based on…
Opinion: Increase transparency at the FDA: We need sunlight to fight the pandemic
The Food and Drug Administration has issued a number of contentious decisions during the Covid-19…
STAT Plus: An FDA safety program is failing to stem the opioid crisis — and manufacturers are mostly to blame
A mandated safety program regulators rely on to minimize opioid abuse and misuse is not…
STAT Plus: The 8 most important leaders of Operation Warp Speed
Below are the eight most important people leading Operation Warp Speed. It is based on…
New document reveals scope and structure of Operation Warp Speed and underscores vast military involvement
WASHINGTON — When President Trump unveiled Operation Warp Speed in May, he declared that it…
New research finds unapproved drugs in brain-boosting supplements
The supplement aisle is rife with “nootropics,” “smart drugs” and “cognitive enhancers” that claim to…
STAT Plus: HHS criticizes Lilly for seeking to curtail discounts for safety-net hospitals
In a stern rebuke, the Department of Health and Human Services has taken Eli Lilly…
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STAT Plus: FDA proposes a ‘modest’ change to a rule for policing off-label marketing
After years of controversy, the Food and Drug Administration has issued a proposed rule to…
STAT+ Conversations: The D.C. Diagnosis
Each week, STAT Plus subscribers get exclusive access to live discussions with STAT reporters and…
Listen: The CDC’s credibility crisis, pandemic PR, and virtual conference malaise
How should governments talk about Covid-19? Can the Centers for Disease Control and Prevention rebuild…
Trump’s attacks highlight CDC’s stumbles on public health messaging
WASHINGTON — Robert Redfield’s statement was unambiguous: A Covid-19 vaccine, he said, might not be…
STAT Plus: FDA warns Sprout for failing to mention risks in radio ad for Addyi
The Food and Drug Administration has admonished Sprout Pharmaceuticals for running a radio ad that…
Top health official echoes Trump’s Covid-19 views, drawing accusations of politicizing U.S. mental health agency
Reopen the schools, diminish the seriousness of the coronavirus pandemic, and the economy comes first….
Public trust in CDC, Fauci, and other top health officials is evaporating, poll finds
WASHINGTON — A new poll paints a bleak picture of Americans’ views toward the coronavirus…
STAT Plus: Blueprint Medicines wins U.S. approval for genetically targeted lung cancer drug
The Food and Drug Administration on Friday approved a new drug from Blueprint Medicines for…
STAT Plus: A second U.S. agency will review if Moderna disclosed federal funding in vaccine patents
A second U.S. government agency is now reviewing whether Moderna (MRNA) properly disclosed millions of…
FDA intrigue, Covid-19 vaccine timelines, and editing elected officials
Should the FDA commissioner resign? How fast can vaccine trials move? And what do Chelsea…
Prominent biotech leaders release Covid-19 guidelines calling for FDA independence, data transparency
WASHINGTON — A group of prominent biotech CEOs are calling on their peers and the…