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Why is the FDA funded in part by the companies it regulates?

The FDA receives almost half its funding from companies it regulates, such as drug and medical device makers. Is this something you should be concerned about?

Exterior of the Pfizer World headquarters building. Pfizer produced the first COVID-19 vaccine to gain emergency use authorization. Sam Aronov/Pacific Press/LightRocket via Getty Images

The Food and Drug Administration has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated. Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug.

As a pharmacist and medication and dietary supplement safety researcher, I understand the vital role that the FDA plays in ensuring the safety of medications and medical devices.

But I, along with many others, now wonder: Was this move a clever win-win for the manufacturers and the public, or did it place patient safety second to corporate profitability? It is critical that the U.S. public understand the positive and negative ramifications so the nation can strike the right balance.

Black and white photo of men crowded around a conference table.
Members of the German public prosecutor’s office announce that pharmaceutical company executives will go on trial over the thalidomide case March 15, 1967. Keystone/Getty Images

The FDA blocks thalidomide

Americans in the early 20th century were outraged when they found out that manufacturers used poor-quality methods for producing food and medication, and used unsafe, ineffective and undisclosed addictive ingredients in medications. The resulting Food, Drug and Cosmetic Act of 1938 gave the taxpayer-funded Food and Drug Administration new authority to protect the U.S. consumer.

One of the FDA’s most shining successes occurred in the late 1950s when the agency refused to approve thalidomide. By 1960, 46 countries allowed pregnant women to use thalidomide to treat morning sickness, but the FDA refused on the grounds that the studies were insufficient to demonstrate safety. Debilitating birth defects resulting from thalidomide arose in Europe and elsewhere in 1961. President John F. Kennedy heralded the FDA in 1962 for its stance. An FDA driven by the data – and not corporate pressure – prevented a major tragedy.

Protesters with makeshift tombstones demonstrate.
AIDS activists protest the slow approvals process for drugs to treat HIV/AIDS on Oct. 11, 1988 in Rockville, Md. Peter Ansin/Getty Images

How AIDS changed how the FDA is funded

The FDA continued its work fully funded by U.S. taxpayers for many years until this model was upended by a new infectious disease. The first U.S. case of HIV-induced AIDS occurred in 1981. It was rapidly spreading, with devastating complications like blindness, dementia, severe respiratory diseases and rare cancers. Well-known sports stars and celebrities died of AIDS-related complications. AIDS activists were incensed about long delays in getting experimental HIV drugs studied and approved by the FDA.

In 1992, in response to intense pressure, Congress passed the Prescription Drug User Fee Act. It was signed into law by President George H.W. Bush.

With the act, the FDA moved from a fully taxpayer-funded entity to one funded through tax dollars and new prescription drug user fees. Manufacturers pay these fees when submitting applications to the FDA for drug review and annual user fees based on the number of approved drugs they have on the market. However, it is a complex formula with waivers, refunds and exemptions based on the category of drugs being approved and the total number of drugs in the manufacturers portfolio.

Over time, other user fees for generic, over-the-counter, biosimilar, animal and animal generic drugs, as well as for medical devices, were created. As time passed, the FDA’s funding has increasingly come from the industries that it regulates. Of the FDA’s total US$5.9 billion budget, 45% comes from user fees, but 65% of the funding for human drug regulatory activities are derived from user fees. These user fee programs must be reauthorized every five years by Congress, and the current agreement remains in effect through September 2022.

Have user fees worked?

The FDA and the drug or device manufacturers negotiate the user fees. They also negotiate performance measures that the FDA has to meet to collect them, and proposed changes in FDA processes. Performance measures include things such as how quickly the FDA responds to meeting requests, how quickly it generates correspondence, and how long it takes from submission of a new drug application until the FDA approves or refuses to approve a drug or product.

Because of the additional funding generated by user fees and performance measures that the FDA has to meet, the FDA is quicker and more willing to discuss what it wants to see in an application with manufacturers. It also offers clearer guidance for manufacturers. In 1987, it took 29 months from the time a new drug application was filed by the manufacturer for the FDA to decide whether to approve a medication in the U.S. In 2014, it only took 13 months and by 2018, it was down to 10 months.

Changes in more recent years have also increased the number of standard new drug applications approved the first time around by the FDA from 38% in 2005 to 61% in 2018. In diseases where there are not many medication options for patients, the FDA has a priority review process, where 89% of new drug applications were approved the first time around and the approvals were completed in eight months in 2018. All this occurred while the number of new drug applications have been increasing over time.

Most recently, the COVID-19 pandemic has seen the FDA provide emergency use authorization for potential treatments in a matter of weeks, not months. The infrastructure and capacity to review the available information so rapidly is due in large part to the funding from user fees.

While the number and speed of drug approvals have been increasing over time, so have the number of drugs that end up having serious safety issues coming to light after FDA approval. In one assessment, investigators looked at the number of newly approved medications that were subsequently removed from the market or had to include a new black box warning over 16 years from the year of approval. These black box warnings are the highest level of safety alert that the FDA can employ, warning users that a very serious adverse event could occur.

Before the user fee act was approved, 21% of medications were removed or had new black box warnings as compared to 27% afterwards.

Some potential reasons that more adverse effects are coming to light after drug approval include senior FDA officials overturning scientist recommendations, a lower burden of proof for medication approval, and more clinical data in new drug applications coming from foreign clinical trial sites that require additional time to assess in an environment where regulators are rushing to meet tight deadlines.

Lack of money limits FDA

User fees are a viable way to shift some of the financial burden to manufacturers who stand to make money from the approval and sale of drugs in the lucrative U.S. market. Successes have occurred and provided U.S. citizens with medication more quickly than before.

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However, without careful consideration of what is being negotiated, the FDA can become weak and ineffective, unable to protect its citizens from the next thalidomide. There are some signs that the pendulum may be swinging too far in the direction of the manufacturers. Additionally, while drug approval functions at the FDA are well funded, the FDA is insufficiently funded to protect consumers from other issues such as counterfeit drugs and dietary supplements because they cannot collect user fees to do so. In my view, these functions need to be identified and require additional taxpayer funding.

C. Michael White does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Spread & Containment

Middle-aged Americans in US are stressed and struggle with physical and mental health – other nations do better

Adults in Germany, South Korea and Mexico reported improvements in health, well-being and memory.

Middle age was often a time to enjoy life. Now, it brings stress and bad health to many Americans, especially those with lower education levels. Mike Harrington/Getty Images

Midlife was once considered a time to enjoy the fruits of one’s years of work and parenting. That is no longer true in the U.S.

Deaths of despair and chronic pain among middle-aged adults have been increasing for the past decade. Today’s middle-aged adults – ages 40 to 65 – report more daily stress and poorer physical health and psychological well-being, compared to middle-aged adults during the 1990s. These trends are most pronounced for people who attained fewer years of education.

Although these trends preclude the COVID-19 pandemic, COVID-19’s imprint promises to further exacerbate the suffering. Historical declines in the health and well-being of U.S. middle-aged adults raises two important questions: To what extent is this confined to the U.S., and will COVID-19 impact future trends?

My colleagues and I recently published a cross-national study, which is currently in press, that provides insights into how U.S. middle-aged adults are currently faring in relation to their counterparts in other nations, and what future generations can expect in the post-COVID-19 world. Our study examined cohort differences in the health, well-being and memory of U.S. middle-aged adults and whether they differed from middle-aged adults in Australia, Germany, South Korea and Mexico.

A middle-aged woman looking sad sitting in front of artwork.
Susan Stevens poses for a photograph in her daughter Toria’s room with artwork Toria left behind at their home in Lewisville, N.C. Toria died from an overdose. Eamon Queeney/For The Washington Post via Getty Images

US is an outlier among rich nations

We compared people who were born in the 1930s through the 1960s in terms of their health and well-being – such as depressive symptoms and life satisfaction – and memory in midlife.

Differences between nations were stark. For the U.S., we found a general pattern of decline. Americans born in the 1950s and 1960s experienced overall declines in well-being and memory in middle age compared to those born in the 1930s and 1940s. A similar pattern was found for Australian middle-aged adults.

In contrast, each successive cohort in Germany, South Korea and Mexico reported improvements in well-being and memory. Improvements were observed in health for each nation across cohorts, but were slowed for Americans born in the 1950s and 1960s, suggesting they improved less rapidly than their counterparts in the countries examined.

Our study finds that middle-aged Americans are experiencing overall declines in key outcomes, whereas other nations are showing general improvements. Our cross-national approach points to policies that could could help alleviate the long-term effects arising from the COVID-19 pandemic.

Will COVID-19 exacerbate troubling trends?

Initial research on the short-term effects of COVID-19 is telling.

The COVID-19 pandemic has laid bare the fragility of life. Seismic shifts have been experienced in every sphere of existence. In the U.S., job loss and instability rose, household financial fragility and lack of emergency savings have been spotlighted, and children fell behind in school.

At the start of the pandemic the focus was rightly on the safety of older adults. Older adults were most vulnerable to the risks posed by COVID-19, which included mortality, social isolation and loneliness. Indeed, older adults were at higher risk, but an overlooked component has been how the mental health risks and long-haul effects will likely differ across age groups.

Yet, young adults and middle-aged adults are showing the most vulnerabilities in their well-being. Studies are documenting that they are currently reporting more psychological distress and stressors and poorer well-being, compared to older adults. COVID-19 has been exacerbating inequalities across race, gender and socioeconomic status. Women are more likely to leave the workforce, which could further strain their well-being.

A older women hugs her daughter.
Middle-aged people often have parents to take care of as well as children. Ron Levine/Getty Images

Changing views and experiences of midlife

The very nature and expectations surrounding midlife are shifting. U.S. middle-aged adults are confronting more parenting pressures than ever before, in the form of engagement in extracurricular activities and pressures for their children to succeed in school. Record numbers of young adults are moving back home with their middle-aged parents due to student loan debt and a historically challenging labor and housing market.

A direct effect of gains in life expectancy is that middle-aged adults are needing to take on more caregiving-related duties for their aging parents and other relatives, while continuing with full-time work and taking care of school-aged children. This is complicated by the fact that there is no federally mandated program for paid family leave that could cover instances of caregiving, or the birth or adoption of a child. A recent AARP report estimated that in 2020, there were 53 million caregivers whose unpaid labor was valued at US$470 billion.

The restructuring of corporate America has led to less investment in employee development and destabilization of unions. Employees now have less power and input than ever before. Although health care coverage has risen since the Affordable Care Act was enacted, notable gaps exist. High numbers of people are underinsured, which leads to more out-of-pocket expenses that eat up monthly budgets and financially strain households. President Biden’s executive order for providing a special enrollment period of the health care marketplace exchange until Aug. 15, 2021 promises to bring some relief to those in need.

Promoting a prosperous midlife

Our cross-national approach provides ample opportunities to explore ways to reverse the U.S. disadvantage and promote resilience for middle-aged adults.

The nations we studied vastly differ in their family and work policies. Paid parental leave and subsidized child care help relieve the stress and financial strain of parenting in countries such as Germany, Denmark and Sweden. Research documents how well-being is higher in both parents and nonparents in nations with more generous family leave policies.

Countries with ample paid sick and vacation days ensure that employees can take time off to care for an ailing family member. Stronger safety nets protect laid-off employees by ensuring that they have the resources available to stay on their feet.

In the U.S., health insurance is typically tied to one’s employment. Early on in the COVID-19 pandemic over 5 million people in the U.S. lost their health insurance when they lost their jobs.

During the pandemic, the U.S. government passed policy measures to aid people and businesses. The U.S. approved measures to stimulate the economy through stimulus checks, payroll protection for small businesses, expansion of unemployment benefits and health care enrollment, child tax credits, and individuals’ ability to claim forbearance for various forms of debt and housing payments. Some of these measures have been beneficial, with recent findings showing that material hardship declined and well-being improved during periods when the stimulus checks were distributed.

I believe these programs are a good start, but they need to be expanded if there is any hope of reversing these troubling trends and promoting resilience in middle-aged Americans. A recent report from the Robert Wood Johnson Foundation concluded that paid family leave has a wide range of benefits, including, but not limited to, addressing health, racial and gender inequities; helping women stay in the workforce; and assisting businesses in recruiting skilled workers. Research from Germany and the United Kingdom shows how expansions in family leave policies have lasting effects on well-being, particularly for women.

Middle-aged adults form the backbone of society. They constitute large segments of the workforce while having to simultaneously bridge younger and older generations through caregiving-related duties. Ensuring their success, productivity, health and well-being through these various programs promises to have cascading effects on their families and society as a whole.

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Frank J. Infurna receives funding from the National Institute on Aging and previously from the John Templeton Foundation. The content is solely his responsibility and does not necessarily represent the official views of the funding agencies.

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Commodities

Euro 2020 – a football tournament where the big players come from China and the US

Much of the money that pays for the competition is spent to build global brands.

Simon Lehmann / Alamy Stock Photo

With Euro 2020 now under way after a year of pandemic delay, football fans will be hoping for great performances from Europe’s finest players. Some of us will watch the tournament unfold on our Hisense televisions, and many will choose to order in some half time refreshments, maybe via the Just Eat delivery service, possibly sent using a Vivo mobile phone.

Sustained by cans of Heineken, as goals are scored, supporters will upload celebration clips on to TikTok. And after the final, what better way to recharge than by arranging a holiday on Booking.com, perhaps flying on Qatar Airways.

For while fans will have their eyes firmly fixed on the efforts of players worth billions of pounds on the field, another big money game will be taking place off it. The Euros is one of the world’s biggest sport events, and a bonanza for corporate sponsors and partners (just a few of which are mentioned above).

In return for being exposed to the eyes of the world, Euros sponsors pay huge amounts of money. Just how much is difficult to say, as fees are commercially sensitive data. But in one case – that of Alipay (part of the Alibaba empire) – it is believed the Chinese company paid £176 million for an eight year deal.

UEFA has sold these deals in three ways: National Team Football Official Sponsors, Euro 2020 Official Sponsors, and Euro 2020 Official Licensees. And the origins of the companies and brands sponsoring this year’s event are a clear indication of how the beautiful game is valued by the corporate world.

Alongside UEFA partners such as FedEx and Konami, each of the national teams bring their own roster of sponsors, which makes for quite a cluttered selection of brands competing for attention. There’s England’s £50 million, five-year contract with BT, for example, while the Germans will bring Lufthansa to the tournament, Carlsberg will promote its association with Denmark and South Korea’s Hyundai will be represented by the Czech Republic.

The list goes on (and on). To capture the complex network of sponsors at Euro 2020 we created a network graphic of some of the most prominent and significant deals on show over the coming weeks. For reasons of clarity, we wern’t able to include every sponsor, but the range on display is revealing.

Graphic of Euro 2020 teams and sponsors.
Euro 2020 teams and associated sponsors. Paul Widdop and Simon Chadwick, Author provided

What becomes immediately clear is that although the UEFA European Championship is a continental tournament, its commercial reach is truly global. A significant number of sponsors are either not European or else have divisions that operate way beyond the borders of Europe.

At the same time, the sponsorship portfolio shows us that football is at the heart of the entertainment, lifestyle and digital economies. Gone are the days of motor-oil and office photocopier sponsorships. Instead we see a profusion of drinks brands, confectionery products and airlines.

In addition, the sponsorship of teams appears to go hand-in-hand with the promotion of national identity and national industry. “Brand Germany” for instance, is strongly represented by some of the country’s most important corporations, including Adidas and Volkswagen.

The appearance of Gazprom meanwhile, reflects the increasing use by nations of sponsorship as a geopolitical instrument. Indeed, the state owned Russian gas company has recently put its associations with UEFA and others to influential use.

Europe’s own goal

Equally, “Brand China” is now a major industrial and political power, and home to five of UEFA’s biggest tournament sponsors (Alipay, Antchain, Hisense, TikTok and Vivo).

Corporate America continues to endure too, represented by the likes of Coca Cola and IMG. The US has always been the home of contemporary sport sponsorship, and the country’s businesses continue to derive significant commercial value from it.

In fact, the underdogs in this big-money corporate competition appear to be the Europeans themselves. For an event being staged in countries including England, Italy, Spain and Romania, UEFA draws very few of its sponsors from the continent. Instead, it is clear that organisations from China and the US have both the financial muscle and the tactical brains to successfully dominate the tournament.

This reflects broader global trends which indicate the declining presence of European industry. European companies account for a falling percentage of global output. The market capitalisation of European firms is way behind that of American corporations and is fast being caught by Chinese firms. And the world’s technological hot spots are found in places such as Shenzhen and Silicon Valley, not in Europe.

Whether the footballing squad from France, Portugal or Switzerland lifts the trophy in July, there is no doubt that the UEFA tournament will be an on field triumph for Europe.

But the forces of globalisation, digitalisation and politico-economic change, reflected in the Euros’ portfolio of sponsors, will keep on playing long after the final whistle blows. And European industry could pay the penalty with a swift exit from the global industrial competition.

Simon Chadwick works with UEFA on its Certificate in Football Management programme.

Paul Widdop ne travaille pas, ne conseille pas, ne possède pas de parts, ne reçoit pas de fonds d'une organisation qui pourrait tirer profit de cet article, et n'a déclaré aucune autre affiliation que son organisme de recherche.

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Science

EU adds another rare blood condition as side effect of AstraZeneca shot

Europe’s drug regulator on June 11 identified another rare blood condition as a potential side effect of AstraZeneca’s Covid-19 vaccine and said it was looking into cases of heart inflammation after inoculation with all coronavirus shots.

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EU adds another rare blood condition as side effect of AstraZeneca shot

(Reuters; )

Europe’s drug regulator on Friday identified another rare blood condition as a potential side effect of AstraZeneca’s (AZN.L) COVID-19 vaccine and said it was looking into cases of heart inflammation after inoculation with all coronavirus shots.

The European Medicines Agency’s (EMA) safety committee said that capillary leak syndrome must be added as a new side effect to labelling on AstraZeneca’s vaccine, known as Vaxzevria.

People who had previously sustained the condition, where fluids leak from the smallest blood vessels causing swelling and a drop in blood pressure, should not receive the shot, the EMA added.

The regulator first began looking into these cases in April and the recommendation adds to AstraZeneca’s woes after its vaccine was associated with very rare and potentially lethal cases of blood clotting that come with a low platelet count.

Last month, the EMA had advised against using the second AstraZeneca shot for people with that clotting condition, known as thrombosis with thrombocytopenia syndrome (TTS).

The committee reviewed six validated cases of capillary leak syndrome in people, mostly women, who had received Vaxzevria, including one death. Three had had a history of the condition.

A vial of AstraZeneca coronavirus vaccine is seen at a vaccination centre in Westfield Stratford City shopping centre, amid the outbreak of coronavirus disease (COVID-19), in London, Britain, February 18, 2021. REUTERS/Henry Nicholls/File Photo

AstraZeneca declined to immediately comment.

More than 78 million Vaxzevria doses have been administered in the European Union, Liechtenstein, Iceland & Norway and Britain.

Britain’s regulator, the MHRA said on Thursday it had received 8 reports of capillary leak syndrome in the context of more than 40 million doses of the AstraZeneca vaccine given, and currently does not see a causal link.

Separately, the EMA said it was continuing its probe into cases of heart inflammation known as myocarditis and pericarditis, primarily following inoculation with the Pfizer/BioNTech (PFE.N), (22UAy.DE) and Moderna mRNA shots, but also after the J&J (JNJ.N) and AstraZeneca vaccines.

U.S. health officials said on Thursday they had registered a higher-than-expected number of heart inflammation cases in young men who received a second dose of the mRNA shots, though a causal relationship could not be established. read more

Israel’s Health Ministry said this month it had found a likely link to the condition in young men who received the Pfizer/BioNTech shot. read more

Both Pfizer and Moderna have acknowldged the observations but said a causal association with their vaccines has not been established.

BioNTech said adverse events, including myocarditis and pericarditis, are being regularly and thoroughly reviewed by the companies and regulatory authorities.

“More than 300 million doses of the Pfizer-BioNTech COVID-19 vaccine have been administered globally and the benefit risk profile of our vaccine remains positive.”

The United States and Israel have been months ahead of the EU in vaccinating men below 30, who are particularly prone to heart inflammation, giving them potentially more cases to analyse.

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-advises-against-astrazeneca-shot-people-with-rare-blood-condition-2021-06-11

 

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