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Biden administration threatens seizure of US-funded drug patents if prices too high on December 7, 2023 at 2:00 pm Business News | The Hill

Published

12 months ago

December 7, 2023

The Biden administration is rolling out a framework to enforce the government’s march-in authorities on drugs developed with taxpayer dollars, saying if drugmakers refuse to make their products “reasonably” available, then the government is prepared to give other companies license to produce those drugs at a lower cost.

Under the Bayh–Dole Act of 1980, the government retains certain rights on any products produced through a public-private partnership using federal funding. This legislation allows federal agencies that provided the funding to compel companies that make such products to provide a “nonexclusive, partially exclusive, or exclusive” license to a “responsible applicant.”

If the company refuses to grant a license for its product, the government has the authority to grant the license itself.

These are referred to as march-in rights, as they allow the federal government to “march in” and issue a license for a product on its own.

While the government has had this authority for decades, it has never exercised this right. Shortly before leaving office, the Trump administration proposed a rule that would have narrowed the terms in which march-in rights could be used, preventing them from being exercised on the basis of “business decisions” related to the “pricing of commercial goods and services.”

Though the public comment period on this rule was allowed to continue in its entirety, the Biden administration ultimately did not finalize it. The Biden White House said it is now prepared to make use of this power for the first time.

“American taxpayers pay more for research than any country in the world: hundreds of billions of dollars on research relevant to developing new drugs through the [National Institutes of Health] and other agencies. But at the same time, pharmaceutical companies charge Americans two to three times — and sometimes even more than that — for the same drugs than what they can charge in other countries,” White House domestic policy adviser Neera Tanden said in a briefing.

The issue of high-priced, taxpayer-funded drugs has frequently been brought up, most recently when it came to the cost of COVID-19 vaccines. Throughout this year, lawmakers such as Sen. Bernie Sanders (I-Vt.) grumbled over the price hikes of coronavirus vaccines from Moderna and Pfizer, arguing the investment of taxpayer funds into these medicines was meant to promote public health and not corporate profits.

The departments of Health and Human Services (HHS) and Commerce will be releasing a proposed framework stipulating that the high costs of drugs developed with taxpayer funds will contribute to whether a medication is considered to be available on a “reasonable” basis.

The two agencies said in March they would be reviewing the federal government’s march-in authorities.

“Too often, patent and other laws have been misused to inhibit or delay for years and sometimes even decades competition for generic drugs and biosimilars, which overall denies Americans access to lower-cost drugs,” Tanden said.

White House national economic adviser Lael Brainard said: “We’ll make clear that when drug companies won’t sell taxpayer funded drugs at reasonable prices, we will be prepared to allow other companies to provide those drugs for less.”

The provisions in the Bayh–Dole Act act specify that a federal agency can issue its own license of a taxpayer-funded product if it’s determined that:

The current exclusive licensee has not or is not expected to make “practical application” of the invention

It’s necessary in order to “alleviate health or safety needs”

This action is needed to meet “requirements for public use” under federal regulations

And action is needed because the product is not being “manufactured substantially” in the U.S., a requirement of the Bayh–Dole Act that can be waived if a company shows that manufacturing in the U.S. is not “commercially feasible.”

Brainard said the administration is also taking up this authority in response not only to high drug prices, but also to promote competition in the industry.

“In the pharmaceutical industry, the four largest companies control almost half of all revenues, leading to less competition and higher prices for American consumers,” Brainard said.

When asked which drugs may be subject to march-in rights, senior administration officials declined to elaborate, saying this action is not about any specific medicine. Officials said the framework reflects the interagency thinking of several agencies, including HHS and the National Institutes of Health.

Ahead of the announcement, Pharmaceutical Research and Manufacturers of America (PhRMA) spokesperson Megan Van Etten issued a statement responding to the proposed framework, saying, “This would be yet another loss for American patients who rely on public-private sector collaboration to advance new treatments and cures. The Administration is sending us back to a time when government research sat on a shelf, not benefitting anyone.”

PhRMA is one of several plaintiffs currently suing to stop Medicare price negotiation established through the Inflation Reduction Act, a measure that administration officials said this framework is building on.

The framework will be open to public comment for 60 days.

Along with this action, the administration also announced it will be launching a public inquiry into “corporate greed in health care” to stop anticompetitive mergers and practices. As such, the Justice Department, HHS and the Federal Trade Commission will be requesting information on how the control that private equity and corporations have on health care is impacting Americans.

Updated at 10:43 a.m. ET

Administration, Business, Health Care, News, Bayh-Dole Act, Department of Commerce, Department of Health and Human Services, Department of Justice, drug costs, federal funding, Federal Trade Commission, Inflation Reduction Act, march-in rights, National Institutes of Health, pharmaceutical industry, prescription drug costs The Biden administration is rolling out a framework to enforce the government’s march-in authorities on drugs developed with taxpayer dollars, saying if drugmakers refuse to make their products “reasonably” available, then the government is prepared to give other companies license to produce those drugs at a lower cost. Under the Bayh–Dole Act of 1980, the…

Business

The Cities Bracing for Trump’s Immigration Crackdown

Published

3 weeks ago

November 8, 2024

Bolanle Media Staff

In the wake of Donald Trump’s recent election victory and his promise of “the largest deportation operation in American history,” several major U.S. cities are bracing for potentially seismic shifts in their economic and social landscapes. As the nation grapples with the implications of this proposed policy, urban centers that have long been havens for immigrant communities find themselves at the epicenter of a looming storm.

Los Angeles, often dubbed the “City of Angels,” stands to lose more than its celestial nickname suggests. As a primary gateway for immigrants, the city’s vibrant tapestry of cultures and its economic engine could face significant disruption. From the bustling streets of Koreatown to the sun-drenched orchards of the Central Valley, the absence of undocumented workers could leave gaping holes in the city’s workforce and cultural identity.

Across the country, New York City, with its iconic skyline and melting pot reputation, faces its own reckoning. The Big Apple’s 5.9 million immigrants, many of whom are undocumented, form the backbone of industries ranging from construction to healthcare. The potential exodus could transform neighborhoods like Jackson Heights and Flushing, altering the very essence of what makes New York a global city.In the Sunshine State, Miami’s tropical allure belies the turbulent times ahead. Home to 2.5 million immigrants, the city’s economy relies heavily on sectors like tourism and hospitality – industries where undocumented workers often fill crucial roles. The potential deportation of these workers could send shockwaves through Miami’s economic ecosystem, from South Beach’s glitzy hotels to the agricultural heartlands of South Florida.

Chicago, the “City of Big Shoulders,” may find those shoulders significantly weakened. With 1.7 million immigrants in its metropolitan area, the Windy City’s diverse neighborhoods and industries face an uncertain future. From the meatpacking plants to the tech startups, Chicago’s economic resilience could be tested like never before.

In the Lone Star State, Houston and Dallas stand as twin testaments to the complexities of immigration policy. These Texas titans, each home to large immigrant populations, could see their booming economies stumble. The construction sites that dot their ever-expanding skylines and the service industries that keep these cities humming could face unprecedented labor shortages.

Out West, the San Francisco Bay Area’s reputation as a bastion of innovation and progress could be challenged. The region’s tech industry, often reliant on immigrant talent, might find itself grappling with a new reality. From Silicon Valley’s coding campuses to the agricultural expanses of the Central Valley, California’s economic powerhouse could face a reckoning. Phoenix, rising from the Sonoran Desert, could see its growth trajectory altered. As Arizona’s urban center, it stands at the forefront of the immigration debate, potentially facing not just economic impacts but social and political upheaval as well.

These cities, along with others like San Diego and Las Vegas, are not just facing potential economic disruptions. They are staring down the barrel of profound social change. Family separations, community fragmentation, and the erosion of cultural enclaves built over generations are all possible consequences of mass deportations. Moreover, the fiscal implications are staggering. Undocumented immigrants contribute billions in taxes annually, often without receiving the full benefits of their contributions. Their sudden absence could leave gaping holes in city budgets, potentially affecting public services and infrastructure projects.

As these urban centers brace for impact, the debate rages on. Supporters of stricter immigration policies argue for the need to enforce laws and protect American jobs. Critics warn of economic devastation and the unraveling of America’s urban fabric. What’s clear is that America’s cities stand at a crossroads. The coming months and years will likely reshape urban landscapes in ways both visible and invisible. From the foods we eat to the services we rely on, from the neighborhoods we call home to the very character of our cities, the impacts of this proposed immigration crackdown could be far-reaching and long-lasting. As the nation watches and waits, these cities – vibrant, diverse, and economically vital – find themselves on the front lines of a policy that could redefine what it means to be an American city in the 21st century.

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Business

How Trump’s Deportation Plans Could Reshape Major Cities

Published

3 weeks ago

November 8, 2024

Bolanle Media Staff

In the wake of Donald Trump’s recent election victory, his ambitious plans for mass deportations have thrust America’s urban centers into the spotlight. As the nation grapples with the potential implications of what Trump calls “the largest deportation operation in American history,” cities across the country are bracing for significant changes that could reshape their economic, social, and cultural landscapes.

The stakes are particularly high for metropolitan areas like New York, Los Angeles, Houston, Dallas, and Miami, which host the largest populations of unauthorized immigrants. These cities, along with other major urban hubs such as Chicago, Washington D.C., and San Francisco, stand at the forefront of a looming transformation that could reverberate throughout the nation.

Economic Tremors

Economists warn that the proposed deportations could send shockwaves through urban economies. Mark Zandi, chief economist at Moody’s, cautions that businesses would face “significant challenges” if a substantial number of immigrants were removed. Industries such as construction, hospitality, and healthcare—pillars of urban economies—could face severe labor shortages.

Joe Brusuelas, chief economist at RSM, emphasizes the potential ripple effects: “The native-born workforce cannot meet current labor demands.” This labor gap could lead to increased wages, potentially rekindling inflation—a concern that looms large over city planners and policymakers alike.

Community Fabric Under Strain

Beyond economic considerations, the social fabric of cities hangs in the balance. Elena, a Nicaraguan immigrant in Houston, voices a fear echoed in immigrant communities across the nation: “I’m scared… This is my home.” The threat of family separations, particularly in mixed-status households, casts a long shadow over urban neighborhoods.

Immigrant advocacy groups like FIEL are mobilizing, advising clients to prepare for “anything that can happen.” This atmosphere of uncertainty could lead to decreased community engagement and cooperation with local authorities, potentially impacting public safety and community cohesion.

Cities at a Crossroads

As the debate intensifies, cities find themselves at a crossroads. Some, like New York and Los Angeles, have historically positioned themselves as “sanctuary cities,” often at odds with federal immigration enforcement. The impending clash between federal policy and local governance promises to be a defining feature of this new political landscape.

Meanwhile, the logistical challenges of implementing such a massive deportation operation remain daunting. Questions abound regarding detention facilities, transportation networks, and the sheer manpower required to carry out Trump’s vision.

Looking Ahead

As America’s urban centers brace for potential change, the full impact of Trump’s deportation plans remains to be seen. Legal challenges are all but certain, and the resilience of America’s cities will be put to the test.

What is clear is that the coming months and years will be pivotal for urban America. As Jason Miller, a senior Trump adviser, puts it, the plan is to “immediately reinstate” immigration policies from Trump’s first term. For America’s cities, this could mean a period of unprecedented change, challenge, and, potentially, transformation.

As the nation watches and waits, the story of America’s cities in the face of this ambitious deportation plan is just beginning to unfold. The outcome will undoubtedly shape the future of urban life in America for years to come.

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Business

Donald Trump Wins 2024 USA Election

Published

3 weeks ago

November 6, 2024

Bolanle Media Staff

Based on the election results, Donald Trump has indeed won the 2024 U.S. presidential election, defeating Vice President Kamala Harris. Here’s an analysis of the key statistics and implications:

Electoral College Victory

Donald Trump has secured the presidency by winning crucial battleground states and flipping some key states that were previously held by Democrats. The final Electoral College tally is still being determined, but Trump has surpassed the 270 electoral votes needed to win.

Battleground State Performance

Trump’s victory was largely secured by winning several critical swing states:

Wisconsin: Trump’s win here was pivotal in securing his path to victory.
Pennsylvania: This state flipped back to Republican control.
Georgia: Another key state that Trump managed to win back.
Michigan: Trump successfully flipped this traditionally Democratic stronghold.

Popular Vote and Voter Priorities

While the final popular vote tally is still being calculated, exit polls provide insight into voter priorities:

Economy and democracy were top concerns for voters.
Abortion and immigration also played significant roles in voter decision-making.

Congressional Control

The election results extend beyond the presidency:

Republicans are set to take back the Senate majority, securing at least 51 seats.
Control of the House of Representatives remains undetermined.

Media Implications

The outcome of this election could be seen as a challenge to mainstream media narratives for several reasons:

Polling Discrepancies: Many pre-election polls suggested a tight race or even a slight Harris advantage in key states. Trump’s victory, particularly in battleground states, may indicate that polls underestimated his support.
Narrative Shifts: Throughout the campaign, much of the mainstream media focused on Trump’s legal challenges and controversies. His victory suggests that these issues may not have resonated with voters as much as economic and policy concerns.
Voter Priorities: The emphasis on issues like the economy and immigration in voter decision-making may indicate a disconnect between media focus and voter concerns.
Electoral Predictions: Many mainstream outlets were cautious about predicting a Trump victory, even as results began to favor him. This hesitancy could be seen as a reflection of broader media skepticism about Trump’s chances.
Underestimation of Trump’s Base: The results suggest that Trump’s core support remained strong and potentially grew, despite negative coverage in much of the mainstream media.

It’s important to note that while the election outcome may challenge some media narratives, it doesn’t necessarily invalidate all mainstream reporting. The complex factors influencing voter behavior and the challenges of accurate political forecasting remain subjects of ongoing analysis and debate.

As the dust settles on this historic election, both the media and political analysts will likely engage in extensive reflection on the factors that led to Trump’s victory and the implications for future political coverage and analysis.