Category: FDA

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FDA panel says preterm birth drug should be withdrawn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The only treatment in the USA to prevent premature births is ineffective and should be withdrawn from the market, according to the Food and Drug Administration’s (FDA) Obstetrics, Reproductive and Urologic Drug Advisory Committee.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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New Medicare Advantage Tool To Lower Drug Prices Puts Crimp In Patients’ Choices

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.

By Susan Jaffe  | Kaiser Health News | September 17, 2018 | This KHN story also ran on 

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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Trump unveils plan to cut drug prices

 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.]…

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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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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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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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] …

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] …

Biomedical research bill becomes law, but critics raise concerns over long-term implementation

Susan Jaffe | Washington Correspondent for The Lancet | 14 December 2016

The 21st Century Cures Act that President Barack Obama signed into law this week dedicates – but doesnthe-lancet-usa-blog-logo1‘t guarantee – billions of dollars to accelerating the discovery of new drugs and medical devices and getting them to patents more quickly, as well as supporting opioid addiction treatment and reforms in mental health care.

President Barack Obama signs the 21st Century Cures Act, Tuesday, Dec. 13, 2016. (Photo by Susan Jaffe)

The overwhelming support for the law marks a stark contrast from the Affordable Care Act, another landmark health reform bill Obama signed in the second year of his presidency.  Republicans promise to repeal it as soon as the new Congress convenes next month and Donald Trump is sworn in as president. But before the promised elimination of the ACA, Congress took nearly $5 billion from its Prevention and Public Health Fund to pay for most of the law.[Continued here.]

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