Tag: FDA

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.]…

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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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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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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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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After a weekend of negotiations and demonstrations, shutdown disrupts health agencies

Susan Jaffe | Washington Correspondent for The Lancet | 22nd January 2018

On the first anniversary of Donald Trump’s inauguration as the 45th president of the United States on January 20, 2018, the federal government ground to a shutdown and hundreds of thousands of women and their supporters rallied against the new president in dozens of cities across the country. [Continued here.]  

 

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Science appointments in the USA

  Volume 389, Number  10088
    24 June 2017

WORLD REPORT    Slow appointments and vacant positions in federal agencies challenge the stability of research in the USA.   Susan Jaffe, The Lancet’s Washington correspondent, reports.  

     As President Donald Trump rolls out his domestic agenda, his proposed budget cuts and lingering vacancies in key federal agencies have rattled some people in the biomedical research and science community.
     “This has been the most anxious time in science that I have seen in this country”, said Rush Holt, chief operating officer at the American Association for the Advancement of Science (AAAS), which represents 250 scientific societies and academies serving 10 million members. Holt cited a litany of reasons: “fake news” that distorts science, “policy making based on wishful thinking rather than evidence, funding proposals that are nonsensical, and unfilled positions in government agencies”.  [Continued here]  

 

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Experts confident of congressional funding for US Cures Act

lancet cover 2
Volume 389,  Number 10065
14  January 2017

How future funding for the landmark 21st Century Cures Act and repeal of the Affordable Care Act may affect its success.  [Interviews with lead sponsors Representatives Fred Upton, Diana DeGette, NIH Director Francis Collins, and patient advocates.  Full article here] …

EpiPen’s price-gouging response “sickens” Congressional panel

Susan Jaffe | Washington Correspondent for The Lancet | 28th September 2016

The latest drug company chief to appear before Congress did not dodge questions by taking refuge in the Fifth Amendment’s protection against self-incrimination, as did Martin Shkreli, the former CEO of Turing Pharmaceuticalthe-lancet-usa-blog-logo1s.  But after a nearly four-hour congressional hearing last week investigating spikes in Mylan’s EpiPen prices, Maryland Democrat Elijah Cummings told Mylan CEO Heather Bresch, “You might as well have taken the Fifth, too, with the kind of information that we’ve gotten here today.” [Continued 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]  …

USA grapples with high drugs costs

 lancet cover 2Volume 386, Number  10009 
28 November 2015
WORLD REPORT   More Americans are getting health insurance, including coverage for prescription drugs, but high prices may make them inaccessible. Susan Jaffe, The Lancet’s Washington correspondent, reports.
 Patients in the USA pay more for prescription drugs than almost anywhere else in the world, forcing as many as one in four who can’t afford the high prices to go without their medicine last year, according to a Kaiser Family Foundation survey. So even though more Americans have health insurance, the new therapies and cures that can prevent more expensive health complications might be out of reach.
After several well-publicised, huge spikes in drug prices—including Turing Pharmaceutical’s increase for pyrimethamine (marketed as Daraprim) from US$13·50 to $750 a pill—the problem is drawing unprecedented attention from nearly every quarter: the Obama Administration, Congress, state officials, health insurance companies, drug makers, as well as the physicians and their patients who have clamoured for help for years. It also surfaced during this month’s Democratic presidential debate.
Heather Block, a patient advocate from Delaware who spoke at a day-long pharmaceutical forum hosted by the US Department of Health and Human Services (HHS) earlier this month, pays $9800 a month for the drugs she takes to treat breast cancer that has spread to her liver and lungs. Although she has Medicare coverage, she is still responsible for a share of her medical expenses. “Innovation is meaningless if nobody can afford it”, she said. “I still face financial insecurity and eventually bankruptcy—if I live that long.”     [Continued here ]
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21st Century Cures

lancet cover 212 August 2015
A dispatch from our Washington correspondent on the sluggish progress of the 21st Century Cures Act.
lancet test tubes 081215
Republicans and Democrats in the U.S. House of Representatives last month overwhelmingly passed the 21st Century Cures Act  aimed at speeding up drug development.  But the Senate is not expected to vote on its version until next year.
More than 80 percent of the House backed the legislation after it was unanimously — a word rarely heard on Capitol Hill — approved by the House Committee on Energy and Commerce.   In the process, the bill was revised to address concerns that drug approvals would happen a little too quickly, circumventing safety and efficacy standards. [Continued here]
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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]…

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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