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 400, Issue 10362
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The only treatment in the USA to prevent premature births is ineffective and should be withdrawn from the market, according to the Food and Drug Administration’s (FDA) Obstetrics, Reproductive and Urologic Drug Advisory Committee.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.]
…Volume 400, Issue 10346
WORLD REPORT A patchwork of state laws replace abortion rights once guaranteed by Roe v Wade. Susan Jaffe reports from Washington, DC.
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Volume 400, Issue 10345
2 July 2022
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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 10335
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.
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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 399, Issue 10321
WORLD REPORT The founder of Theranos was found guilty of defrauding some investors, but cleared of charges that she misled patients. Susan Jaffe reports.
Volume 398, Issue 10315
Volume 398, Issue 10294
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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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Volume 396, Number 10260 31 October 2020
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.]…
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.]
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Volume 394 Number 10213 30 November 2019 
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.
Some physicians and patient advocates are concerned that the pursuit of lower Part B drug prices could endanger very sick Medicare Advantage patients if they can’t be treated promptly with the medicine that was their doctor’s first choice.
Starting next year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to treat cancer, rheumatoid arthritis, macular degeneration and other serious diseases.
Under the new rules from Medicare, these private Medicare insurance plans could require patients to try cheaper drugs first. If those are not 
effective, then the patients could receive the more expensive medication prescribed by their doctors.
Insurers use such “step therapy” to control drug costs in the employer-based insurance market as well as in Medicare’s stand-alone Part D prescription drug benefit, which generally covers medicine purchased at retail pharmacies or through the mail. The new option allows the private Medicare plans — an alternative to traditional, government-run Medicare — to extend that cost-control strategy to these physician-administered drugs.
…Critics of the new policy, part of the administration’s efforts to fulfill President Donald Trump’s promise to cut drug prices, say it lacks some crucial details, including how to determine when a less expensive drug isn’t effective. [Continued at Kaiser Health News and NPR]
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Volume 391, Number 10136
2 June 2018
WORLD REPORT The president’s wide-ranging plan to reduce prescription drug prices won’t be easy to achieve, experts say. Susan Jaffe, The Lancet’s Washington correspondent, reports.
“We will have tougher negotiation, more competition, and much lower prices at the pharmacy counter. And it will start to take effect very soon“, said President Donald Trump.
How soon will depend on what steps the administration takes on its own, through regulations and other mandates, and what changes can only be achieved through new laws enacted by Congress, which will increasingly be preoccupied by November’s election. [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 390, Number 10108
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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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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Volume 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 co
nservative 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] …
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] …