The Dictatorship

FDA drug approvals: Makary and Prasad say one study will be enough

Published

4 months ago

February 20, 2026

FDA drug approvals: Makary and Prasad say one study will be enough

WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.

Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Macary and a top deputy, Dr. Vinay Prasadwrote in a New England Journal of Medicine piece published Wednesday.

The announcement is the latest example of Makary and his team changing longstanding FDA standards and procedures with the stated goal of slashing bureaucracy and accelerating the availability of new medicines.

Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments for new medications that serve “national interests.”

It contrasts with the FDA’s more restrictive approach to other products, including vaccines.

In their piece published Wednesday, Makary and Prasad state that dropping the two-trial requirement reflects modern advances that have made drug research “increasingly precise and scientific.”

“In this setting, overreliance on two trials no longer makes sense,” they write. “In 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”

The FDA officials predicted the shift would lead to “a surge in drug development.”

Dr. Janet Woodcock, the FDA’s former drug director, said the change makes sense and reflects the FDA’s decades-long move toward relying on one trial, combined with supporting evidence, for various life-threatening diseases, including cancer.

“The scientific point is well taken that as we move toward greater understanding of biology and disease we don’t need to do two trials all the time,” said Woodcock, who led the FDA’s drug center for about 20 years before retiring in 2024.

The two-study standard for drugs dates to the early 1960s, when Congress passed a law requiring the FDA to review data from “adequate and well-controlled investigations,” before clearing new medications. For decades, the agency interpreted that requirement as meaning at least two studies, preferably with a large number of patients and significant follow-up time.

The reason for requiring the second study was to confirm that the first trial’s results weren’t a fluke and could be reproduced.

But beginning in the 1990s, the FDA increasingly began accepting single studies for the approval of treatments for rare or fatal diseases that companies often struggle to test in large numbers of patients.

Over the last five years, roughly 60% of first-of-a-kind drugs approved each year have been cleared based on a single study. The shift reflects laws passed by Congress that directed regulators to be more flexible when reviewing drugs for serious or hard-to-treat conditions.

Woodcock said the new policy announced Wednesday will mainly impact drugs for common diseases that previously weren’t eligible for reduced testing standards.

“It’s not the cancers and the rare diseases that will be affected by this,” she noted. “The agency has been approving those on a single trial already.”

The latest approach from FDA leadership contrasts with the agency’s recent actions on vaccines, gene therapies and other treatments.

Last week, the FDA’s vaccine division, headed by Prasad, refused to accept Moderna’s application for a new mRNA flu shot, saying its clinical trial was insufficient. Then on Wednesday the agency reversed coursesaying it would review the vaccine after Moderna agreed to conduct an additional study in older people.

Separately, Prasad has rejected a string of experimental gene therapies and biotech drugs, citing the need for additional studies or more definitive evidence. The trend has weighed on the stocks of many biotech companies and clashed with Makary’s public statements promoting the speed and flexibility of the FDA’s reviews.

Woodcock said the drug industry will have to wait and see whether the FDA’s approach to promising experimental therapies changes.

“Implementation will be everything,” she said. “Since the agency’s approach is unclear, and the industry is already baffled, I don’t think this adds any illumination.”

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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.

The Dictatorship

California voters to decide billionaire tax measure in November

Published

30 minutes ago

June 26, 2026

Blue Light Newsroom

California voters to decide billionaire tax measure in November

Jun. 25, 2026, 10:25 PM EDT

California voters will consider a controversial proposal in November to temporarily raise taxes on billionaires after the labor union backing the measure announced Thursday it would forge ahead despite pressure from critics to withdraw it.

The proposal, backed by the Service Employees International Union Healthcare Workers West, would impose a one-time 5% tax on individuals whose net worth exceeds $1 billion and who were living in the state as of Jan. 1, 2026. The goal is to generate $100 billion in revenue, mainly to fund the state’s Medicaid system after federal cuts.

“I am all in on this,” union President Dave Regan said on a Zoom call, adding that opponents of the proposal are “totally out of touch.”

Democratic Gov. Gavin Newsom and many traditional allies of the union oppose the measure. They argue it is a temporary fix for an ongoing problem and that it would push the ultrawealthy to leave the state, taking the money they would contribute in income taxes with them. Newsom, who is considering a presidential run as he prepares to leave office in January, has generally opposed tax increases during his time as governor.

A coalition of healthcare, education and housing groups — including the California Medical Association and California School Boards Association — banded together last week to fight the tax.

“The dangerous wealth tax directly threatens vital funding for education and schools, healthcare and clinics, public safety, and infrastructure projects by making California’s revenue even more volatile,” the coalition said in a statement.

Brian Brokaw, a Newsom political adviser who is leading a political committee opposing the tax, said it would “make California’s biggest challenges worse.”

“Driving away the state’s sustainable tax base for a one-time grab is bad policy and an even worse deal for 40 million Californians who will be left holding the bag,” he said in a statement.

Under the proposal, the state would spend the money generated from the tax over multiple years. The nonpartisan Legislative Analyst’s Office estimates that the proposal would generate tens of billions of dollars in the first few years, but that income tax revenues would subsequently decline by hundreds of millions of dollars annually.

Many of the Silicon Valley tech moguls who oppose the measure have already moved their assets to other states or threatened to do so to avoid the possible tax. They have also spent millions to try to defeat it.

Since the proposal was announced in October, Google co-founder Sergey Brin has donated $82 million to a political committee called Building a Better California that backs a variety of initiatives designed to blunt the billionaire tax proposal. It has raised more than $118 million, counting Brin’s contributions, from fewer than a dozen donors.

California relies on its top 1% of earnersfor nearly half of its personal income tax revenue.

The union offered to scale back its proposal last week, asking Newsom to back a 2% tax on billionaires instead. But the governor’s office said the lower rate didn’t change his stance.

The proposed tax may have piqued the interest of many Democrats because it comes at a time when they are particularly concerned about affordability, income inequality and federal cutbacks to government programs, said Martin Gilens, a political science professor at the University of California, Los Angeles.

“There’s kind of a perfect storm that sort of bolsters preexisting inclinations to be sympathetic to the idea of raising taxes on the well-to-do,” he said.

But there’s a catch. Support for ballot initiatives often declines as the election nears, and if the measure passes, it’s likely to face legal challenges, Gilens said.

The Dictatorship

Flattery, secrecy and chaos: Bill Pulte’s first week as intel chief

Published

30 minutes ago

June 26, 2026

Blue Light Newsroom

Flattery, secrecy and chaos: Bill Pulte’s first week as intel chief

Jun. 25, 2026, 7:15 PM EDT

Since taking office one week ago, Bill Pulte, the acting director of national intelligence, has busied himself on social media posting flattering photos of President Donald Trump, trivia about a former counterintelligence agent and praising his current staff.

What the Trump loyalist with no intelligence experience has not done is address the public about his plans, or calm the unease and confusion inside the Office of the Director of National Intelligence, which is being described by top officials as “chaotic” amid firings of senior personnel with threats of more to come.

One image posted to the official X account of the Office of the Director of National Intelligence, apparently artificial intelligence-generated, features Trump raising a clenched fist in the air with two B-2 stealth bombers in the sky behind him. Another is an image of the president, his fist clenched, glowering as he stands behind the Oval Office’s Resolute Desk.

In another post, Pulte, who was expected to gut the workforce of the National Counterterrorism Center, instead declared the staff there “true professionals and American patriots” after he said he spent time with them, adding “it is a privilege to work beside them.”

And in an apparent attempt at levity, Pulte reposted a message reminding Americans that Tuesday was “National Typewriter Day” and informing them of the role that a former Army counterintelligence agent played.

“Fun CI fact,” the post reads. “Former Army CI Special Agent Leroy Anderson composed ‘The Typewriter’ on October 9, 1950.”

But Pulte’s arrival has sparked anxiety and fear among the office’s workforce, three former U.S. intelligence officials told MS NOW, granted anonymity to address a sensitive topic.

They said that a half dozen political appointees were removed from their posts and several dozen staffers were sent back to their home intelligence agencies. Beyond that, little else is known about Pulte’s plans.

Rep. Jim Himes, D-Conn., the top Democrat on the House Intelligence Committee, told MS NOW that his requests for more information from the office, known by the acronym ODNI, have been rebuffed.

“I’ve been calling over there all day and can’t get my calls returned,” said Himes.

He later said, “I spoke directly to their office of congressional affairs. They said they had nothing for me.”

“It seems like it’s totally chaotic at the Office of the Director of National Intelligence,” Sen. Mark Warner, D-Va., the ranking Democrat on the Senate Intelligence Committee, said on a podcast Wednesday. “There was word that there was going to be firings and then he said he changed his mind. We don’t know.”

Marc Polymeropoulos, a former senior CIA official and now an MS NOW contributor, said that staff in the intelligence community do not know what to think.

“Everyone is in the same boat and unsure of what is going on,” he said. “That said, there is no love lost for the DNI, as many believe that there is redundancy that does need to be cut.”

The other former U.S. intelligence officials said they agree that the Office of the Director of National Intelligence is in need of reform. The agency was created after a lack of information sharing among U.S. intelligence agencies played a role in the failure to stop the Sept. 11, 2001, attacks. ODNI’s mission is to ensure that the country’s now 18 different intelligence agencies share information with one another.

But the former intelligence officials said Pulte is patently unqualified to design or carry out those reforms.

“As with many things Trump alights upon, there is a sliver of truth here but he goes about addressing it in the worst possible way,” a former senior U.S. intelligence official told MS NOW, granted anonymity over concerns of retaliation. “But mass firings without any kind of sense of what you are trying to accomplish is addressing it in the most ham-handed way.”

That former official, as well as Warner and Himes, have said they fear that Pulte’s mission is to use his position as the nation’s top intelligence official to help Trump interfere in the midterm elections in November.

Pulte, who simultaneously serves as the Trump administration’s top federal housing official as head of the Federal Housing Finance Agency, used government mortgage information to file several criminal referrals against Democrats whom Trump considered enemies, including Sen. Adam Schiff of California and New York State Attorney General Letitia James. None of Pulte’s referrals have resulted in criminal convictions.

One fear expressed by Warner and some former intelligence officials is that Pulte may try to falsely claim that his office has found evidence that foreign governments are secretly funding Democratic candidates.

One way he could do that, they say, is by falsely claiming foreign actors have hacked U.S. voting machines and altered vote totals in favor of Democrats. And Pulte and FBI agents could seize voting machines, ballots and election records in November — as Gabbard did in Fulton County, Georgia, last year at Trump’s behest — as part of voter fraud investigations that please the president.

“I have to tell you, I was extraordinarily concerned about the former director of national intelligence, Tulsi Gabbard, interfering in our election,” Warner told NPR earlier this month. “The concerns I had with Tulsi Gabbard now, upon reflection, look small versus the concerns I have with Bill Pulte.”

David Rohde is the senior national security reporter for MS NOW and a two-time winner of the Pulitzer Prize for International Reporting. Previously he was the senior executive editor for national security and law for NBC News.

The Dictatorship

Barack Obama says Trump gives him a ‘room in his head’

Published

30 minutes ago

June 26, 2026

Blue Light Newsroom

Barack Obama says Trump gives him a ‘room in his head’

Jun. 25, 2026, 5:37 PM EDT

Former President Barack Obama slammed President Donald Trump for obsessing over him while serving in the nation’s highest office.

“I obviously, you know, have a room in his head. A suite in his head,” Obama said an an episode of the podcast “All The Smoke,” posted Wednesday.

“Look, first of all, when I was president, the last thing I had time to do was worry about what somebody said, or what my predecessor did,” Obama told the two hosts, former NBA players Matt Barnes and Stephen Jackson. “They’re gone. I’ve got work to do.”

Trump has a long history of publicly insulting the former president, often invoking Obama’s middle name, Hussein.

Trump has also heavily promoted the false and racist “birther” conspiracy theory, which claimed that Obama was ineligible to serve as president because he was born in Kenya rather than the United States.

Earlier this year, Trump drew criticism after sharing a racist artificial intelligence-generated video on his Truth Social account depicting the former president and former first lady Michelle Obama as apes. The video was later deleted, and Trump did not apologize.

Before launching the war against Iran with Israel on Feb. 28, Trump repeatedly criticized the Joint Comprehensive Plan of Action, the 2015 diplomatic agreement primarily negotiated by Obama that also limited Iran’s nuclear capabilities in exchange for sweeping economic sanctions relief.

More recently, Trump trashed the newly debuted Obama Presidential Center in Chicago as a “very unattractive building” and “total disaster,” adding that when his presidential library opens, it will be “on time, on budget, best location in Miami.”

Without mentioning Trump by name, Obama criticized leaders who fixate on their predecessors, characterizing their priorities as misplaced.

“If you’re doing the job right, everyday, you’ve got five, ten things that are real hard. And you have to be constantly focused,” Obama said.

“The idea that I’d be worrying about somebody who came before and me trying to measure, ‘What’s he done today?’ Constantly worrying about that is a strange thing to me. It shows me somebody who’s not focused on the American people and the job they’re supposed to do.”

Erum Salam is a breaking news reporter for MS NOW, with a focus on how global events and foreign policy shape U.S. politics. She previously was a breaking news reporter for The Guardian.