Volume 403, Issue 10445
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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Volume 403, Issue 10423WORLD 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]…
Volume 401, Issue 10385
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.]…
Volume 399, Issue 10347
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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Volume 399, Issue 10330WORLD REPORT Robert Califf will have to face several controversial health issues in his second tenure as commissioner. Susan Jaffe reports from Washington, DC.
Volume 398, Issue 10315
Volume 395 Number 10231 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.]
…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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Volume 389, Number 10088WORLD 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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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] …
Susan Jaffe | Washington Correspondent for The Lancet | 28th September 2016
s. 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] 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] …
Volume 386, Number 10009 12 August 2015
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]…
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]
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.
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]
Volume 379, Issue 9828
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.