Tag: Food and Drug Administration

Cyclospora in the USA: why is it so hard to stop?

Volume 407, Issue 10553
01 August 2026
WORLD REPORT  The epidemiological challenges of the parasite have been compounded by recent cutbacks at US health agencies. Susan Jaffe reports from Washington DC. 

“Make America Healthy Again” is more than a slogan for Health and Human Services Secretary Robert F Kennedy Jr, who has pledged to make Americans’ food supply safe and improve their nutrition. However, the recordbreaking outbreaks of cyclosporiasis across the USA are proving how difficult it is to keep those promises, especially after the agencies responsible for protecting health have been depleted by staff reductions and funding cuts. [Continued here.]

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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.]…

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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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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Trump administration begins to confront the opioid crisis

 Volume 390, Number 10108   
11 November 2017

 

WORLD REPORT    As the Presidential Commission releases its recommendations, Trump moves closer to defining his policies against the opioid epidemic  Susan Jaffe, The Lancet’s Washington correspondent, reports.  

“Having failed to recognise how this epidemic was going to grow in proportion and take vigorous enough action, we need to be willing to be far more vigorous so we don’t continue with that mistake,” said Food and Drug Administration Commissioner Scott Gottlieb.   [full story here]

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Scott Gottlieb sworn in to head the FDA

lancet cover 2Volume 389, Number  10084 

27 May 2017 

WORLD REPORT    Scott Gottlieb becomes commissioner of the FDA, as the agency’s role is threatened by an administration adverse to regulation.  Susan Jaffe, The Lancet’s Washington correspondent, reports.

Only 6 months ago, Scott Gottlieb was still a resident fellow at the American Enterprise Institute, a conservative thinktank, when he presented testimony to a US Senate committee investigating prescription drug prices. Before he began, he volunteered that he was “a reformed government bureaucrat, having worked at FDA [US Food and Drug Administration] for a number of years”. He blamed astonishing price hikes—500% in the case of Mylan’s EpiPen—on “regulatory failures stemming from FDA policy, and I think that policy can be fixed”.

Gottlieb was sworn in as the 23rd commissioner of the FDA after being approved earlier this month by the US Senate, over the strong objections of most Democrats. Now Gottlieb will have a chance to fix a daunting array of policies. [Continued here] …

NIH hopes funding increases will continue

 lancet cover 2Volume 387, Number  10019
13 February 2016
WORLD REPORT   The US National Institutes of Health welcomed a record budget boost that might be the start of more sustained support. The Lancet’s Washington correspondent, Susan Jaffe, reports.

The US Congress recently approved the largest single increase in funding for the National Institutes of Health (NIH) in 12 years—a US$2 billion raise that was twice as much as President Barack Obama requested. But almost as soon as NIH supporters stopped cheering, they began to worry about next year’s budget, and the challenge of a new public health threat, Zika virus.

NIH Director Francis Collins told The Lancet that the funding boost “was enormously gratifying”. But if it is “a one-hit wonder”, he said “it won’t be sufficient to take full advantage of the remarkable scientific opportunities and talent that is out there”.   [Continued here] [podcast here]

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Shkreli pleads the Fifth on drug price hikes

Susan Jaffe | Washington Correspondent for The Lancet | 10th February 2016

Like many Americans, members of Congress are frustrated and angry about the huge spikes in prescription drug prices. While a congressional hearing held last week to investigate the practice united Democrats and Republicans in outrage, it did not reveal potential solutions.

     The unwilling star witness was Martin Shkreli, the former head of Turing Pharmaceuticals who was responsible for the company’s decision to raise the price of Daraprim, used to treat toxoplasmosis, a parasitic infection that affects HIV patients, from $13.50 to $750 a pill. [Continued here]  …

Budget boon for biomedical research

Susan Jaffe | Washington Correspondent for The Lancet | 31st December 2015

budget 123115The US Congress has become famous for political gridlock  but sThe Lancet USA blog logohortly before going home for the holidays, members approved a 2,009-page budget for fiscal year 2016 with generous increases for some key health and science agencies, most notably the ailing National Institutes of Health. [Continued here.]…

21st Century Cures Act progresses through US Congress

image Volume 385, Issue 9983,    30 May 2015

WORLD REPORT A bill to speed up the translation of biomedical discoveries is getting wide support, but some argue that it is not adequately funded.   Susan Jaffe, The Lancet’s Washington correspondent, reports.

An ambitious bipartisan plan to accelerate medical innovation in the USA is moving ahead in a Congress famous for political gridlock.

The proposed 21st Century Cures Act was approved unanimously on May 21 by the US House of Representatives’ Committee on Energy and Commerce. The massive bill would promote discovery of new medicines and get them to patients more quickly. But the bill’s bipartisan support nearly collapsed when Democrats insisted on additional funds for the two federal agencies intricately involved in carrying out the bill’s far-reaching provisions.

Behind-the-scenes discussions finally yielded an infusion of US$10 billion over 5 years for the National Institutes of Health (NIH). Shortly before the committee vote, $550 million over 5 years was added for the Food and Drug Administration (FDA), which is responsible for ensuring new treatments are safe and effective. …But funding for both agencies did not come easy, is still uncertain, and might fall far short of what is needed.  [Continued full text or PDF]…

US FDA: the Margaret Hamburg years

lancet cover 2

Volume 385, Issue 9970, 28 February 2015

WORLD REPORT US Food and Drug Administration commissioner Margaret Hamburg is stepping down after nearly 6 years in office. The Lancet‘s Washington correspondent, Susan Jaffe, reports on her achievements.

Margaret Hamburg

At the end of March, Margaret Hamburg is leaving what has got to be one of the toughest unelected US Government jobs outside of the Pentagon—commissioner of the US Food and Drug Administration (FDA).

A champion of science-based regulation and streamlined approvals for breakthrough drugs, the Harvard-trained physician is one of the two longest-serving FDA commissioners in five decades.

The FDA is responsible for the safety of 20% of the products Americans buy, including more than US$1 trillion dollars worth of goods that might seem to have little in common, such as artificial hips, dietary supplements, gene therapy, surgical lasers, prescription drugs for human beings and animals, nanotechnology products, cosmetics, blood and biologics products, tobacco, and—last but not least—most of the food we eat (excluding meat and poultry, which are the domain of the agriculture department). The agency has 16 000 employees. [article continued in full text or PDF]

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image Volume 381, Issue 9882, Pages 1975 – 1976, 8 June 2013

WORLD REPORT Health and science agencies in the USA have been operating on reduced budgets, enforced by sequestration, for just over 3 months Susan Jaffe reports from Washington, DC.

The automatic budget cuts known as sequestration that the US Congress approved in 2011 were intended to be so onerous that they would never happen. Lawmakers would surely find a more reasonable way to save at least US$1·2 trillion over the next decade before the cuts would begin in 2013. Instead, Republicans and Democrats could not agree on an alternative, and the first wave of cuts, totalling $85 billion through to September, 2013, are phasing in for most non-defence US Government operations. Everything from White House tours to the most promising cancer research have been limited by a lack of funding.

..Many services provided by the US Department of Health and Human Services (HHS) are affected, including programmes at the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), and medical research funded by the National Institutes of Health (NIH). Even the Affordable Care Act (ACA)—President Barack Obama’s landmark health reform law—will feel the impact, with supporters worried that enrolment for next year’s new health insurance coverage will have a difficult start in October. [FULL STORY AS PDF]

 

US sequester hits health and science programmes

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A new law passed in July to strengthen the work of the US Food and Drug Administration may hit some serious barriers to implementation. Susan Jaffe reports from Washington, DC.

image WORLD REPORT   Volume 380, Issue 9852, Pages 1458 – 1459, 27 October 2012

The massive drug and medical device safety bill that won extraordinary near-unanimous support in the US Congress—despite a budget crisis and a contentious political campaign—is facing major challenges less than 3 months after President Barack Obama signed it into law in July. And in the process, prospects may be fading for additional reforms. [MORE]

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image Volume 379, Issue 9828, Page 1775, 12 May 2012

The US Food and Drug Administration is calling for greater reliance on global partners to improve the safety of America’s foreign imports. Susan Jaffe reports from Washington, DC.

In its latest effort to promote a global strategy for protecting Americans against unsafe imported pharmaceutical, food, and medical products, the US Food and Drug Administration (FDA) has called for unprecedented international cooperation to cope with seemingly overwhelming challenges. FULL STORY