The Dictatorship
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
President Trump spoke to Live Nation CEO before antitrust case was settled, company lawyers reveal
NEW YORK (AP) — President Donald Trump spoke personally with the chief executive of Live Nation in the weeks before the Justice Department abruptly settled its longstanding antitrust lawsuit against the entertainment giant and its Ticketmaster subsidiary, the company revealed in a court filing.
Lawyers for Live Nation told the court on Monday that Trump and the company’s CEO, Michael Rapino, spoke about the antitrust lawsuit in February, but didn’t discuss “substantive terms” of any potential settlement.
They also said that White House lawyers were involved in some of the numerous in-person meetings, videoconferences, telephone calls and written communications between the company and the Justice Department in February and March.
Just days into the March trial, the Justice Department announced a settlement that most states refused to join, saying it did not go far enough to curb the company’s dominance over concert venues and ticketing for live events though Ticketmaster.
The trial continued, and a jury concluded several weeks later that the company was a monopoly that cost concertgoers and sports fans.
The White House declined to comment on Live Nation’s disclosure, referring questions to the Justice Department, which didn’t immediately respond to messages seeking comment.
The revelation comes as the Justice Department has faced criticism that its independence has been threatened by substantial oversight or interference from the White House and the president.
The Justice Department and dozens of states originally teamed up to bring the antitrust lawsuit against Live Nation.
Among other things, the jury in New York found Ticketmaster’s anticompetitive practices led to people in 22 states paying an extra $1.72 per ticket, which the judge could order the companies to pay back.
State attorneys general who sued Live Nation said the verdict could potentially lead to lower ticket prices for music fans.
The federal government’s settlement deal included a cap on service fees at some amphitheaters, plus some new ticket-selling options for promoters and venues — potentially allowing, but not requiring, them to open doors to Ticketmaster competitors such as SeatGeek or AXS.
In April, Live Nation said in a statement that the verdict “is not the last word on this matter.”
WASHINGTON (AP) — U.S. President Donald Trump and Vice President JD Vance say their interim deal to end the war with Iran will deliver a financial windfall to American farmers.
But the Iranians deny it. And in the absence of more details, sanctions experts are flummoxed over exactly how billions of dollars’ worth of Iranian assets would make their way to the American heartland from the escrow accounts where they’ve been locked for years by U.S. sanctions.
A tentative agreement reached last week would reopen the Strait of Hormuz, through which a fifth of the world’s oil and natural gas once passed, and allow Iran to start selling its oil freely again during a 60-day period when the two countries will continue negotiating key issues. The memorandum of understanding also promised to unfreeze Iranian assets.
Trump’s deal has come under fire for failing to address the reasons the president cited for going to war with Iran on Feb. 28, including curbing Tehran’s nuclear ambitions, its missile program and its support for militant groups such as Hezbollah in Lebanon and Hamas in Gaza.
Lashing back at critics Tuesday on his Truth Social media platform, Trump said U.S. farmers would get a payday: The U.S. Treasury Department, he wrote, would release the Iranian assets “into escrow, controlled by the U.S.A., and will be used for the purchase of food and medical supplies, exclusively from the United States, including Corn, Wheat, and Soybeans from our great American farmers. These are things that are desperately needed by Iran.’’
Vance, who spoke about the proposal after high-level talks in Switzerland, and Trump say that any frozen funds and assets held outside of Iran will be used to buy U.S. crops.
But the Iranians deny that’s part of the deal. A spokesperson for the Iranian Foreign Ministry, Esmail Baghaei, said any agricultural purchases would be based on “prices and quality,’’ not terms dictated by Washington.
“It is interesting that the philosophy and goal of the war, which was the destruction of the Iranian civilization and the collapse of Iran, has become enriching American farmers,” Baghaei said.
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Iran’s ambassador in Geneva, Ali Bahreini, rejected Vance’s contention that the U.S. and Qatar would dictate how Iran uses unfrozen funds. “Iran is the only country who decides what to do with those assets,” he told reporters.
A U.S. official dismissed the contradiction, asserting that Iranian leaders were speaking to their domestic audience. The official spoke on condition of anonymity because they were not authorized to speak on the record.
Joseph Glauber, a research fellow emeritus at the International Food Policy Research Institute, said Iran was unlikely to abandon its other trade partners on food.
Iran’s major suppliers include Brazil, India, Turkey, the European Union, Canada, Australia and Argentina, he said. Trump’s demand to buy from the U.S. would “create some hard feelings with some of our competitors.”
Under previous sanctions, the U.S. has required that money foreign countries spend on imports from Iran — such as South Korean purchases of oil and Iraqi purchases of Iranian electricity — be locked in escrow accounts and typically released only if the Treasury approves and if the proceeds go toward “non-sanctionable’’ items such as food and medicine.
On Monday, the U.S. Treasury approved the sale of Iranian oil, petrochemicals and petroleum products through Aug. 21. It did not mention any escrow accounts.
Richard Goldberg of the Foundation for Defense of Democracies, who coordinated efforts to put diplomatic pressure on Iran in the first Trump administration, said in a post on X that he would welcome “a clarification that Iran is actually restricted to only buying U.S. agricultural products.”
Richard Nephew, senior research scholar at Columbia University’s Center on Global Energy Policy, said it’s unclear what the new U.S.-Iran agreement actually means for releasing restricted Iranian assets.
Could the U.S. require that the assets be used to buy American farm products?
“Well, we can try!’’ Nephew, who helped design Iran sanctions in the Obama and Biden administrations, said by email. “All you really need to do is to tell a foreign bank that they can move the money but only to a U.S. bank to buy soybeans or whatever.”
Banks do not have to comply, he said. If they refuse, the U.S. could sanction them as well.
But it’s rare for the U.S. to conduct itself that way, he added, “in part because we don’t usually like to give the impression that we treat national security issues as a cash grab.”
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Associated Press writers Josh Boak and Michelle L. Price in Washington contributed to this report.
Wednesday marks four years since the Supreme Court issued its landmark Dobbs decisionwhich effectively overturned Roe v. Wade and repealed the constitutional right to an abortion. On “Morning Joe,” co-host Mika Brzezinski explained how the ruling set off a domino effect across the United States, affecting not just abortion-related care, but also altering “the state of women’s healthcare as a whole.”
As Brzezinski noted, states across the country have enacted harsher abortion restrictions since the 2022 ruling, with 13 outright banning the procedure with very limited exceptions. This has created a climate of fear among those who treat pregnant patients, with many healthcare providers worrying that any care involving an abortion could violate the law, even when the mother’s health is at risk.
“We are talking about people dying when they’re miscarrying because doctors are too afraid to intervene and save their lives,” Amy Littlefield, abortion access correspondent for The Nation, told MS NOW.
Brzezinski said the laws have effectively limited women’s “access to lifesaving healthcare.”
The MS NOW host reflected on some high-profile stories of pregnant women who faced delayed care in states with near-total abortion bans, noting “the numbers of cases that we’ve covered here on the show of women who have had their lives threatened, have been forced to give birth to dying or dead babies, and then, by the way, denied the access to ever create life again, because they became sterilized in the process.”
“There’s an image I can’t get out of my head,” Brzezinski added, before sharing reporting from ProPublica about Porsha Ngumezi, a 35-year-old mother who died in Texas in 2023 after not receiving timely care for a miscarriage.
“For months afterward, Porsha’s 3-year-old son would chase after women who looked like her on the street, shouting, ‘That’s Mommy!’” Brzezinski said. “That’s the detail I can’t forget. I can’t stop imagining that little boy chasing after strangers on the street. And that story repeats itself.”
You can watch Brzezinski’s full comments in the clip at the top of the page.
Allison Detzel is an editor/producer for MS NOW. She was previously a segment producer for “AYMAN” and “The Mehdi Hasan Show.”
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