Category: FDA

Are Trump’s drug pricing policies saving anyone money?

Volume 407, Issue 10543
23 May 2026
WORLD REPORT   Experts question the effectiveness of the Trump administration’s strategies to cut pharmaceutical costs in the USA.  Washington Correspondent Susan Jaffe reports. 
To lower prescription drug costs for Americans, the Trump Administration wielded tariff threats to gain confidential price agreements with pharmaceutical companies and promises from other countries to pay more for drugs. The lower prices are displayed on the government’s TrumpRx website but critics say that only a few brand name drugs are discounted exclusively on the website. They also say there is no guarantee that drug makers will apply any increased revenue from overseas sales to voluntarily cut prices in the USA.  [Continued here.]

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Health experts condemn US vaccine recommendations

Volume 406, Issue 10510
27 September 2025
WORLD REPORT  The Advisory Committee on Vaccine Practices’ recommendations for COVID-19 vaccination prompt questions and concern. Washington Correspondent Susan Jaffe reports.  
The first meeting of a vaccine advisory committee with all 12 of Health and Human Services (HHS) Secretary Robert F Kennedy Jr.’s handpicked members — bypassing the usual vetting process — produced confusing recommendations, condemned by medical associations and public health experts. Even some members were puzzled at times: they decided to delay a vote on one proposal and approved another after earlier rejecting it. They recommended that Americans should still be vaccinated to prevent serious complications of COVID-19, but added that patients should first discuss the benefits and risks with a health-care provider. Physician groups and public health advocates say the prerequisite is unnecessary and will restrict access. [Continued here.]
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CDC is “in the ICU right now” former officials say

Volume 406, Issue 10508
13 September 2025
WORLD REPORT  Senior officials say HHS Secretary Robert F Kennedy Jr is eviscerating the CDC. Washington Correspondent Susan Jaffe reports.    
The US Centers for Disease Control and Prevention (CDC) implosion was months in the making, senior officials tell The Lancet after they resigned in protest following the dismissal of CDC Director Susan Monarez by Health and Human Services (HHS) Secretary Robert F Kennedy Jr. They describe a gutted agency so damaged that it might not be able to fulfil its core mission to protect Americans from public health threats.  An HHS spokeswoman called their comments “the gripes of disgruntled former employees.”  [Continued here.]
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Trump works towards US tariffs on drug imports

Volume 405, Issue 10490
10 May 2025
WORLD REPORT    Observers warn of the negative health consequences if US President Donald Trump follows through on his promise to impose tariffs on pharmaceuticals. Susan Jaffe reports.  

Prescription drugs were excluded from US President Donald Trump’s tariffs that have rocked global markets and fuelled trade wars. But two recent actions signal the administration’s intention to eliminate that protection. Last month, Trump ordered the Department of Commerce to investigate whether the USA’s dependence on imported pharmaceuticals is a potential national security threat. If so, imposing tariffs would be a likely defence against imports.  [Continued here.]…

Can the FDA fulfil its mission with a smaller workforce?

Volume 405, Issue 10488
26 April 2025
WORLD REPORT    The US Food and Drug Administration’s new commissioner promises to restore public trust despite mass layoffs. Washington Correspondent Susan Jaffe reports. 

Martin Makary fielded questions for nearly 2 h from a Senate committee last month before winning approval to take the helm as commissioner at the Food and Drug Administration (FDA). His early actions have provided some additional answers about how he will likely run an agency that impacts Americans’ daily lives but is depleted by the forced departure of at least 3500 scientists and other staff. [Continued here.]…

Robert Kennedy Jr’s Promises

Volume 405, Issue 10480
1 March 2025
WORLD REPORT    To earn enough Senate votes for confirmation as Secretary of the US Department of Health and Human Services (HHS), Robert F Kennedy Jr made some surprising promises for someone aspiring to become the nation’s top health official. He had to reassure a few sceptical Republican senators that he would not overturn years of accepted public health policies, medical practice, and scientific consensus. And yet, in just the short time since assuming his new post on Feb 13, Kennedy’s actions—and inaction—appear to undermine those commitments as thousands of HHS employees are laid off under President Donald Trump’s executive orders shrinking the size and cost of government. [Continued here.]

 

 

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Trump agenda ignites legal challenges

Volume 405, Issue 10477
8 February 2025 
WORLD REPORT  After just 3 weeks in the White House, US President Donald Trump’s executive orders have caused chaos and concern—and now, resistance. Susan Jaffe reports from Washington, DC.

“There’s nothing unusual about an executive order”, said Professor Emeritus Laurence Tribe, an expert in constitutional law at Harvard Law School. “What is unusual is for the President of the United States to say, ‘I can do anything I want, as long as I package it in an executive order. I can exercise not only the power to enforce the laws, which is basically what the executive branch does, but also the power to ignore law.’ ”  Lawsuits have been filed to block executive orders affecting federal funding, workforce protections, closing the US Agency for International Development, and information on government websites including the Center for Disease Control and Prevention.[Full article here, includes links to updates on legal actions and executive orders.]

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US Supreme Court protects access to abortion medication

Volume 403, Issue 10445
22 June 2024 

WORLD REPORT  Justices did not address claims that mifepristone endangered patients and that its approval by the FDA was flawed. Opponents vow to continue the legal fight. Susan Jaffe reports [continued here].

 

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Imported drugs unlikely to lower US prices any time soon

Volume 403, Issue 10423
20 January 2024 

WORLD REPORT  Americans pay some of the highest prices in the world for prescription drugs, but the decision by the US Food and Drug Administration to allow Florida to import cheaper medications from Canada won’t cut prices any time soon. Although the ruling represents a shift in the decades-long fight for drug importation, opposition from the US pharmaceutical industry, Canadian health officials, and others is expected to block implementation at every stage. [Susan Jaffe reports, here]…

Drug developers caution against US mifepristone ban

Volume 401, Issue 10385
22 April 2023 

 

WORLD REPORT     A lawsuit against the FDA embroils pharmaceutical companies in debates over access to
abortion. Susan Jaffe reports from Washington, DC.

Less than 1 year after the US Supreme Court ended its 1973 constitutional guarantee to an abortion and told state lawmakers that they could decide whether a person ends their pregnancy, abortion is now back before the court. But this fresh legal challenge has dragged the nation’s entire drug approval system along with it, rousing a powerful lobbying group and economic force that has mostly managed to avoid the fray—the pharmaceutical industry. [Continued here.]…

FDA panel says preterm birth drug should be withdrawn

Volume 400, Issue 10362
29 October 2022 

 

WORLD REPORT  Makena has been given to hundreds of thousands of patients over the past 11 years. Susan Jaffe reports from Washington, DC.  

The only treatment in the USA to prevent premature births is ineffective and should be withdrawn from the market, according to the Food and Drug Administration’s (FDA) Obstetrics, Reproductive and Urologic Drug Advisory Committee. The recommendation has renewed scrutiny of a special drug approval process that raises patients’ hopes by allowing them to take medications that have not been fully tested for efficacy and safety [Continued here.] 

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“Chaos” for patients and providers after US abortion ruling

Volume 400, Issue 10346
9 July 2022 

 

WORLD REPORT  A patchwork of state laws replace abortion rights once guaranteed by Roe v Wade. Susan Jaffe reports from Washington, DC.

The US Supreme Court’s bombshell decision overturning Roe v Wade on June 24, 2022, assures Americans that each state can choose whether and under what conditions its residents have a right to a safe and legal abortion. So far, the result is an incoherent and volatile jumble:16 states have severely restricted or banned the procedure and bans in ten more states are likely to take effect in a matter of weeks. [Continued here.]  

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Federal abortion rights end, but not legal challenges

Volume 400, Issue 10345
2 July 2022

WORLD  REPORT  The US Supreme Court’s decision to overturn Roe v Wade is due to spark further court cases. Susan Jaffe reports from Washington, DC. 

The Supreme Court’s momentous decision to abolish the half-century-old federal right to abortion not only rapidly reconfigures the political and legal landscape in the USA, threatening a host of other long-held personal freedoms. The seismic shift also ignites new legal battles within states that ban or severely restrict abortions, only 4 months before the mid-term elections that will establish which party controls Congress for the next 2 years.  Put simply, the ruling is “the legal equivalent of a nuclear bomb”, according to legal affairs correspondent for National Public Radio and veteran Supreme Court observer, Nina Totenberg. [Continued here.] 

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US Infant formula crisis increases scrutiny of the FDA

Volume 399, Issue 10347
11 June 2022 

 

WORLD REPORT Both Republican and Democrat legislators have called for changes following a shortage of breastmilk substitute. Susan Jaffe reports from Washington, DC..  

The leading US producer of infant formula resumed partial operations on June 4 following a 4-month shutdown, but it may take several more weeks before supplies return to normal, along with the shortage-induced panic and desperation of American parents. When the US Food and Drug Administration (FDA) can regain trust in its ability to police the nation’s food manufacturers is another matter.

The agency’s failure to respond quickly to health hazards at the Abbott Nutrition facility in Sturgis, MI, that released potentially contaminated formula across the country has provoked rare bipartisan outrage in Congress and equally rare apologies from the manufacturer. The shutdown and resulting shortage have also prompted calls for major changes in the FDA’s food safety division, along with questions about why one supplier dominates the market. [Continued here.]  

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Medicare covers new Alzheimer’s drug, but there is a catch

Volume 399, Issue 10335
23 April 2022 

 

WORLD REPORT  The federal health plan for older Americans will pay for the controversial new drug aducanumab only for patients participating in clinical trials.  Susan Jaffe reports.  

The Biden administration’s long-awaited decision to pay for a controversial new Alzheimer’s disease treatment, aducanumab, will not make it easier for many older Americans with Medicare health insurance to get it. [Continued here.] 

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Califf takes the helm at the US FDA, again

Volume 399, Issue 10330
19 March 2022 

WORLD REPORT   Robert Califf will have to face several controversial health issues in his second tenure as commissioner. Susan Jaffe reports from Washington, DC.  

Califf takes over amid a lull in the COVID-19 pandemic and an array of hotly debated issues 9 months before a congressional election. The
election results could shrink, if not eliminate, the Democratic majority President Joe Biden needs to propel his health agenda, including the relaunched cancer moonshot and the Advanced Research Projects Agency for Health that would accelerate the development of medical treatments. [Plus new COVID-19 tests and treatments, opioid misuse, accelerated approval process, abortion pill conflict, continued here.] 
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Holmes verdicts prompt questions over justice for patients

Volume 399, Issue 10321
15 January 2022

 

WORLD REPORT   The founder of Theranos was found guilty of defrauding some investors, but cleared of charges that she misled patients. Susan Jaffe reports.

On Jan 3, a federal jury in California found Elizabeth Holmes, creator of the blood-testing startup Theranos, guilty of lying to some of her investors about a portable blood analyser that she claimed would transform health care. It could run dozens of tests from a fingerprick of blood, she said, and deliver dependable results quickly. However, government prosecutors’ account of Holmes’s empty promises and hype failed to convince the jury that she also deceived patients and their doctors who depended on her device’s inaccurate readings. [Continued here.]  
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Theranos founder counters fraud charges in federal trial

Volume 398, Issue 10315
27 November 2021

 

WORLD REPORT   Federal prosecutors charged Theranos’ founder Elizabeth Holmes and former Theranos president Ramesh Balwani with wire fraud and conspiracy to commit wire fraud, alleging that they deceived investors and patients and their doctors by claiming that Theranos’s machine could produce accurate test results from blood collected in its tiny “nanotainer” device instead of several vials. But witnesses for the prosecution testified that the devices did not operate as promised…. “When something is brought forward as the next new thing regardless of whether it’s a drug or device, it needs to go through the process of rigorous scientific and clinical testing, then presented to the scientific community for peer review and ultimately publication”, said Roy Silverstein a haematologist and chair of medicine at the Medical College of Wisconsin. “And I’m not aware of any single publication that ever came out of this Theranos technology.” [Full story here.]  

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US FDA defends approval of Alzheimer’s disease drug

Volume 398, Issue 10294
3 July 2021

 

WORLD REPORT An avalanche of criticism has forced the US Food and Drug Administration to defend its decision to grant accelerated approval for aducanumab, the first new Alzheimer’s disease treatment in two decades. “It will be a very long time before we ever figure out whether or not this drug really works”, said Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School who resigned in protest from an FDA advisory panel that recommended against approval.[Continued here.]

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US drug importation plan hits snag

Volume 397, Issue 10291
12 June 2021

WORLD REPORT The Biden administration says it has “no timeline” for deciding if states can import cheap drugs from Canada. 

President Joe Biden’s administration said last week that it won’t decide whether to allow states to import drugs from Canada anytime soon, if ever. Biden supported drug importation during the presidential campaign, as did his opponent, Donald Trump, to mitigate sky-rocketing drug costs in the USA. Americans pay more per capita for prescription drugs than any other country…. [Continued here.]

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US election 2020: the future of the Affordable Care Act

Volume 396, Number 10260     31 October 2020 

WORLD REPORT   President Donald Trump pledges to replace the Affordable Care Act while his Democratic opponent Joe Biden offers detailed proposals to improve it. Susan Jaffe reports from Washington, DC.

Since winning the presidency in 2016 in large part by promising to eliminate Obamacare, otherwise known as the Affordable Care Act (ACA), Donald Trump has promised more than a dozen times that his replacement plan would be ready soon. The plan would be released in 2 weeks, a White House spokeswoman said 2 months ago.

“We’re going to have a health-care plan that will be second to none”, Trump said in 2017. “It’s going to be great and the people will see that.” And at last week’s final presidential debate, he vowed “to terminate Obamacare, [and] come up with a brand new beautiful health care”.

A decade after the ACA—President Barack Obama’s signature achievement—became law, repealing and replacing Obamacare is again central to Trump’s re-election. And improving and expanding the law is a crucial part of the campaign of his challenger, former Vice President Joe Biden. [Continued here.]     

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US election 2020: research and health institutions

Volume 396, Number 10259

24 October 2020

 

WORLD REPORT   How will the NIH, CDC, and FDA change if President Donald Trump wins a second term or if his Democratic challenger, Joe Biden, defeats him? Susan Jaffe reports from Washington, DC. 

Whoever wins the presidency needs to “restore the CDC and improve it by letting [scientists] know that they will have an opportunity to do the best science and make the best recommendations…” says James Curran, dean of the Rollins School of Public Health at Emory University in Atlanta. [Continued here.]…

Federal Regulators split on antimalarials for COVID-19

Volume 395    Number 10231     
11 April 2020                          
WORLD REPORT   US and French authorities have authorised the use of chloroquine and hydroxychloroquine, but the EU regulator and WHO say the science doesn’t support the decision. Susan Jaffe reports. 
With no “adequate, approved and available” alternative, the US Food and Drug Administration (FDA) is allowing the use of the antimalarial drugs hydroxychloroquine and chloroquine to treat coronavirus disease 2019 (COVID-19).

The FDA’s emergency use authorisation (EUA) issued last week gives physicians the option to prescribe the drugs, which President Donald Trump has recommended. However, both drugs are unproven and untested for COVID-19, and have rare but potentially deadly side-effects.  The decision bypassed the usual drug approval process including doubleblind, placebo-controlled clinical trials, stoking a worldwide debate about whether the drugs are appropriate for treating the disease.

“I think it was resorted to more out of a sense of desperation”, said Joseph Masci, an infectious disease specialist and director of global health at Elmhurst Hospital in Queens, a borough of New York City, which is at the centre of the epidemic in the USA. “It is just an indication of how sudden and massive this outbreak has been.” [Continued here.]  

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Will Trump snuff out e-cigarettes?

Volume 394       Number 10213     30 November 2019   
WORLD REPORT President Trump promised to ban flavoured e-cigarettes, but 11 weeks later, they are still on the shelves. Susan Jaffe reports from Washington. 
When US President Donald Trump announced a plan on Sept 11 to prohibit the sale of most flavoured electronic cigarettes, more than 450 people in the USA had a mysterious lung disease associated with vaping, and six had died, according to the Centers for Disease Control and Prevention (CDC). The ban would be finalised within 30 days, said Health and Human Services Secretary Alex Azar.
The number of cases of the lung disease has since soared to 2290, as of Nov 20, in 49 states, Washington, DC, and the US Virgin Islands. 47 e-cigarette smokers (vapers) have died, according to the CDC. However, as this report went to press, officials from the Trump administration would not disclose when the promised ban would be issued.
…The decision [to implement] a nationwide ban is up to President Trump. “It is a chain of command”, said Robert Califf, a professor of cardiology at Duke University School of Medicine and the FDA commissioner under Trump and former President Barack Obama. “The commissioner reports to the Secretary of Health and Human Services [HHS]and the secretary reports to the president. FDA policies are de facto policies of the Executive Branch, so if the HHS secretary or president chooses to do so, they can intercede.”  [Continued here]  
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Scott Gottlieb steps down from US FDA leadership

 Volume 393, Number 10176      

 16 March 2019       

 

WORLD REPORT   The announcement came as a surprise, prompting many to ask: Can the US FDA commissioner’s policies continue without him? Susan Jaffe reports.

Unlike some government agencies that can toil peaceably in relative obscurity, the FDA is frequently in the headlines. It is responsible for ensuring the safety of products that account for about 20 cents of every dollar US consumers spend—or US$2·5 trillion annually.  …When Gottlieb became commissioner in 2017, the agency had an estimated 1000 vacancies which has now risen to 1400.[Continued here.]
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