Category: FDA

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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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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US presidential candidates’ proposals to reduce drug prices

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Volume 388,  Number 10047
27 August 2016
 WORLD REPORT   US presidential candidates’ proposals to reduce drug prices Clinton and Trump seem to agree on at least some ways to bring down the cost of prescription drugs, but Clinton offers more details.   Susan Jaffe, The Lancet’s Washington correspondent, reports. [Continued here] 
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Biden Pleads for Open Data for Cancer Moonshot

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

Three months after Vice President Joe Biden convened the first meeting of the Cancer Moonshot Task Force—aimed at accelerating the-lancet-usa-blog-logo1cancer prevention, treatment and cures—he pleaded for help from people who know how to marshal massive amounts of health data to create successful businesses, or apps that can guide consumers to the best hospitals. [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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Congress Wrangles Over Funding for Zika Research

Susan Jaffe | Washington Correspondent for The Lancet | 12th February 2016

President Barack Obama asked Congress this week for more than $1.8 billion in emergency funding The Lancet USA blog logoto respond to Zika virus and administration officials wasted no time in explaining why at four congressional hearings less than two days later.

While such Capitol Hill visits are part of the budget process, the looming virus adds a new urgency to the proceedings–though not necessarily enough to deter controversy. [Continued here]…

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.]…

As drug prices go up, some point consumers up north

Susan Jaffe | Washington Correspondent for The Lancet | 8th December 2015
Pharmaceutical sticker shock has renewed American interest in drugs sold in other countries, particularly our northern neighbor.
Many Americans and even government health programs are feeling squeezed by rising drug costs, with federal officials reporting last week that US The Lancet USA blog logohealth care spending in 2014 rose at the fastest rate since 2002 “in part due to the introduction of new drug treatments for hepatitis C as well as of those used to treat cancer and multiple sclerosis.”120815
Treatments for hepatitis C, which affects around 3 million people in the USA, can cost more than $100,000, Health and Human Services Secretary Sylvia Matthews Burwell said at an unprecedented day-long conference on drug pricing HHS hosted last month.
“And that’s an issue for both patients and the organizations and governments that serve them. Since more than three out of four infected adults are baby boomers, this disease has become one of the main cost drivers for Medicare’s prescription program.  Impacts have also been significant in state Medicaid programs.”
…Prompted by the HHS conference and recent price hikes, two leading Senate Republicans, Charles Grassley of Iowa and John McCain of Arizona want Burwell to use a provision of a 2003 law to certify that drug importation is safe and would significantly reduce drug prices.  [Continued here.]
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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.
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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]…

Robert Califf: leading cardiologist is new FDA Deputy

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Volume 385, Issue 9970

28 February 2015

As the new Deputy Commissioner for Medical Products and Tobacco at the US Food and Drug Administration (FDA), world-renowned cardiologist Robert Califf arrives at a time when the FDA’s overall responsibilities have grown exponentially.  The Lancet‘s Washington correspondent, Susan Jaffe, reports.  [article continued as full text or PDF] [Podcast with Dr. Califf here.]

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US FDA: the Margaret Hamburg years

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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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US President’s science panel advises on antibiotic resistance

image Volume 384, Issue 9948, 20 September 2014 

WORLD REPORT The US President’s science council will soon publish its long-awaited report on antibiotic resistance. But will it affect the debate? Washington Correspondent Susan Jaffe reports.

Since its reformation 5 years ago, the President’s Council of Advisors on Science and Technology (PCAST) has grappled with some of the most difficult scientific controversies, including climate change and cybersecurity. In the next few weeks, the council will issue recommendations for controlling antibiotic resistance. “Antibiotic-resistant infections are associated with an additional 23 000 deaths in the USA each year”, Eric Lander, the report’s cochair, told The Lancet. The US Centers for Disease Control and Prevention (CDC) has estimated that the economic effect of antibiotic-resistant infections is at least US$50 billion annually in direct health-care costs and lost productivity. [MORE] [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 380, Issue 9848, Pages 1133 – 1134, 29 September 2012

WORLD REPORT  Comprehensive domestic health-care reform is one of the top defining issues in the campaign, overshadowing global health. Susan Jaffe reports from Washington, DC.

President Barack Obama and his rival Republican Mitt Romney would agree that the American health-care system is unsustainable, providing some of the world’s most expensive and yet fragmented care. But as they campaign for the presidency, the two candidates offer profoundly different solutions.

“The Affordable Care Act helps make sure you don’t have to worry about going broke just because one of your loved ones gets sick”, said Obama, describing his signature legislative achievement at a recent campaign stop in Colorado. “I don’t think a working mom in Denver should have to wait to get a mammogram just because money is tight”, he continued. “That’s why we passed this law. It was the right thing to do.” [more, as PDF]  

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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