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FDA Approves First Oral Alzheimer’s Drug: Legal, Ethical, and Policy Considerations in Drug Approval

On May 15, 2025, the U.S. Food and Drug Administration (FDA) approved the first-ever Oral Alzheimer's Drug, marking a significant milestone in both medical and regulatory history. The approval of this groundbreaking drug raises questions not only about the future of Alzheimer’s treatment but also about the legal and regulatory processes involved in the approval of new pharmaceuticals, especially in the context of highly politicized health issues. This article will explore the various aspects of this approval, focusing on the legal framework, potential policy ramifications, and public debates surrounding the drug’s approval. At the core of the discussion is the tension between rapid innovation in healthcare and the regulatory mechanisms that ensure drug safety and efficacy.
HomeTop News StoriesTrump Administration Enacts Sweeping Drug Price Cuts and Halts Gender-Affirming Care for...

Trump Administration Enacts Sweeping Drug Price Cuts and Halts Gender-Affirming Care for Troops

Introduction

On May 12, 2025, President Donald Trump signed two significant executive orders that have sparked widespread debate across the United States. The first order aims to drastically reduce prescription drug prices by implementing a “Most Favored Nation” (MFN) pricing model, U.S. drug price cuts with those in other developed countries. The second order halts gender-affirming care for transgender individuals in the military, citing concerns over military readiness and unit cohesion.

These actions have profound implications for healthcare policy, civil rights, and the legal landscape in the United States. They raise critical questions about the balance between federal authority and individual rights, the role of the executive branch in shaping healthcare policy, and the ongoing national discourse on transgender rights.

“These executive orders represent a significant shift in federal policy, with potential long-term consequences for both healthcare affordability and the rights of transgender individuals,” said Dr. Emily Thompson, a healthcare policy expert at the Brookings Institution.

Legal and Historical Background

Drug Pricing Reform

The U.S. has long grappled with high prescription drug prices. The MFN model, previously introduced during Trump’s first term, was designed to tie U.S. drug prices to the lowest prices paid by other developed nations. However, the initial attempt faced legal challenges and was ultimately blocked by courts due to procedural issues.

The new executive order revives this model, directing the Department of Health and Human Services (HHS) to negotiate drug prices with manufacturers within 30 days. If negotiations fail, the administration may implement regulatory actions, antitrust measures, or revoke approvals for drugs deemed unsafe or misleadingly marketed.

“The MFN approach challenges the traditional free-market principles by introducing price controls, which could have unintended consequences on drug innovation and availability,” noted Professor Jonathan Blake, a legal scholar at Harvard Law School.

Gender-Affirming Care in the Military

The Trump administration’s decision to halt gender-affirming care for transgender troops is rooted in a series of executive orders aimed at redefining federal recognition of gender identity. Executive Order 14183, titled “Prioritizing Military Excellence and Readiness,” asserts that accommodating gender identities divergent from an individual’s biological sex is inconsistent with military readiness and unit cohesion.

This policy shift reverses previous efforts to allow transgender individuals to serve openly in the military and access necessary medical care. It aligns with broader administrative actions to limit federal support for gender-affirming treatments across various agencies.

“The rollback of transgender rights in the military raises serious constitutional concerns, particularly regarding equal protection under the law,” stated Dr. Laura Simmons, a constitutional law professor at Yale University.

Case Status and Legal Proceedings

Drug Pricing Reform

The pharmaceutical industry has expressed strong opposition to the MFN pricing model, arguing that it could stifle innovation and lead to reduced access to medications. Legal challenges are anticipated, focusing on the executive branch’s authority to impose such pricing mechanisms without congressional approval.

“We are closely examining the legal basis of the executive order and considering all options to protect the interests of patients and the pharmaceutical industry,” said Stephen Ubl, CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA).

Gender-Affirming Care in the Military

Civil rights organizations have filed lawsuits challenging the ban on gender-affirming care for transgender troops. A federal judge in Maryland issued a preliminary injunction blocking the enforcement of the executive order, citing potential violations of constitutional rights.

“The court’s decision underscores the importance of protecting the rights of all service members, regardless of gender identity,” remarked Chase Strangio, Deputy Director for Transgender Justice at the ACLU.

Viewpoints and Commentary

Progressive / Liberal Perspectives

Advocacy groups and Democratic lawmakers have condemned the executive orders, viewing them as attacks on marginalized communities and overreach by the executive branch.

“These actions undermine the progress we’ve made in ensuring equitable healthcare access and protecting the rights of transgender individuals,” said Senator Elizabeth Warren.

Healthcare experts warn that the MFN pricing model could lead to unintended consequences, such as reduced investment in research and development.

“While lowering drug prices is a noble goal, we must be cautious not to hinder the innovation that brings new treatments to patients,” cautioned Dr. Anthony Fauci.

Conservative / Right-Leaning Perspectives

Supporters of the executive orders argue that they represent necessary steps to control healthcare costs and maintain military readiness.

“The MFN model is a bold move to stop Americans from overpaying for medications and to hold pharmaceutical companies accountable,” stated Senator Josh Hawley.

Regarding the military policy, proponents assert that it ensures focus on mission readiness and cohesion.

“Our military must prioritize effectiveness and unity, and this policy supports those objectives,” commented Representative Jim Jordan.

Comparable or Historical Cases 

In order to place the Trump administration’s May 2025 executive orders into proper context, it is instructive to examine parallel historical or legal events that provide insights into the present moment. Two major analogs offer relevant precedent: the international reference pricing model debated during the Trump and Biden administrations, and the “Don’t Ask, Don’t Tell” (DADT) policy affecting LGBTQ+ military service.

First, the Most Favored Nation (MFN) model proposed for drug pricing was initially floated in 2020 under President Trump via an executive order aimed at aligning U.S. drug costs with prices in peer nations. Legal challenges promptly followed. In Association of Community Cancer Centers v. Azar (2021), a federal district court blocked implementation, ruling that the Department of Health and Human Services (HHS) had exceeded its statutory authority and violated the Administrative Procedure Act by bypassing the required notice-and-comment period. That case highlights the judiciary’s insistence on procedural rigor even in the face of urgent public policy concerns.

A second comparative framework lies in the history of LGBTQ+ service in the U.S. military, particularly the 1993–2011 enforcement of DADT. That policy barred openly gay, lesbian, or bisexual individuals from military service and led to the discharge of over 13,000 troops. The policy was ultimately repealed via the Don’t Ask, Don’t Tell Repeal Act of 2010 (Pub.L. 111–321). Similar to the current executive order halting gender-affirming care for transgender service members, DADT was defended on grounds of military readiness and cohesion—arguments that were later discredited by internal Pentagon reports and public opinion.

“The DADT precedent teaches that discriminatory policies often collapse under the weight of legal scrutiny and cultural evolution,” noted Professor Diane Mazur, a former Air Force officer and constitutional law scholar.

Moreover, President Biden’s Executive Order 13988 in 2021 reaffirmed Title VII protections for transgender Americans under Bostock v. Clayton County (2020), a landmark U.S. Supreme Court case which held that discrimination based on gender identity constitutes unlawful sex discrimination.

In both instances—the MFN drug model and transgender military exclusions—prior legal and political outcomes suggest that broad executive actions, particularly those disrupting established norms or touching on civil rights, are subject to intense judicial and legislative pushback. Historical continuity reveals that executive overreach tends to provoke recalibration through the courts, Congress, or public consensus.

Policy Implications and Forecasting 

The dual executive orders issued by the Trump administration in May 2025 mark a pivotal intervention in both healthcare economics and military personnel policy, and their ripple effects may extend well beyond the short-term political landscape. From drug affordability to civil rights within the armed forces, these directives have catalyzed both praise and litigation.

In the case of drug pricing reform, the Most Favored Nation (MFN) strategy is likely to instigate broad systemic change if implemented. Short-term effects may include temporary price reductions on high-cost drugs purchased by Medicare and Medicaid. However, analysts from the Kaiser Family Foundation and Cato Institute caution that price controls might backfire by causing pharmaceutical manufacturers to limit product availability in the U.S. market or prioritize international sales where margins remain higher.

“There’s a delicate balance between affordability and availability—price suppression could diminish innovation and reduce access to life-saving medications,” stated Sally Pipes, President of the Pacific Research Institute.

Long-term forecasting is more ambiguous. Congress may seek to codify elements of the MFN model or design alternative bipartisan frameworks to regulate pharmaceutical pricing more sustainably. The increased politicization of drug policy also raises concerns about executive overreach, especially if future administrations oscillate between regulatory extremes.

Meanwhile, the ban on gender-affirming care for military personnel ignites significant civil liberties debates. The short-term impact could be deeply personal—disruption of existing treatment plans, lowered morale among transgender service members, and elevated rates of attrition. As legal battles unfold, similar to those seen during the Obama-Trump transitions, policy analysts predict heightened judicial scrutiny based on equal protection, medical ethics, and military precedent.

“This policy may ultimately erode military readiness by alienating skilled personnel and sowing division,” warned Dr. Mara Keisling, founding executive director of the National Center for Transgender Equality.

Looking ahead, the Supreme Court’s evolving jurisprudence on gender identity under Bostock v. Clayton County and related cases may define the ultimate legal boundaries of federal transgender policy. Should the Court grant certiorari in challenges to the executive order, its ruling would have profound implications for administrative law and civil rights doctrines.

More broadly, the Trump administration’s directives may encourage a reexamination of the scope and accountability of executive authority, prompting institutional reforms through statutory limitations or judicial interpretations.

Conclusion 

At the confluence of public health, executive authority, and civil rights, the Trump administration’s May 2025 executive orders have opened a new chapter in American governance. The decision to tie U.S. drug prices to those paid by foreign nations, along with the termination of gender-affirming care for military personnel, underscores an administration leveraging broad executive power to enact ideologically-driven reforms with nationwide consequences.

Legally and politically, these actions expose core tensions embedded in the U.S. constitutional structure. The MFN pricing initiative challenges market orthodoxy and questions the separation of powers, as critics argue it intrudes on congressional prerogatives to regulate commerce and appropriations. Meanwhile, the halt to gender-affirming military care intersects with constitutional guarantees under the Fifth and Fourteenth Amendments, implicating both due process and equal protection principles.

“These orders may ultimately force the judiciary to delineate the contours of executive discretion more precisely,” observed constitutional law expert Erwin Chemerinsky.

Opposing camps present coherent, if starkly divergent, rationales. Advocates hail the drug pricing directive as a populist victory against pharmaceutical profiteering. They frame the military care policy as a return to traditional values and operational focus. Critics, on the other hand, regard both as regressive measures that undermine healthcare access and civil equality.

From an institutional standpoint, the unfolding legal challenges will test the limits of agency rulemaking, particularly in the healthcare space, and may invite future legislative responses. The policy oscillations between administrations also amplify calls for more durable, bipartisan frameworks in areas like drug affordability and military inclusion.

Most crucially, these executive orders amplify the enduring national debate about the role of identity, inclusion, and healthcare in American public life. Will the country tolerate a patchwork of rights contingent on political leadership, or will it pursue legal coherence through judicial intervention or congressional consensus?

As stakeholders await court rulings and further regulatory guidance, one thing remains clear: these executive orders do not mark an endpoint, but rather a flashpoint in broader legal and moral reckonings.

“Every era presents us with tests of constitutional endurance; this is one of them,” wrote Linda Greenhouse, Pulitzer-winning legal journalist.

For Further Reading:

  1. “Trump signs order aiming to cut some U.S. drug prices to match lower ones abroad” – CNBC
    https://www.cnbc.com/2025/05/12/trump-signs-order-aiming-to-cut-some-us-drug-prices-to-match-lower-ones-abroad.html
  2. “Trump’s executive order on gender-affirming care faces legal challenges” – The New York Times
    https://www.nytimes.com/2025/02/13/us/politics/trump-gender-affirming-care-executive-order.html
  3. “Pharmaceutical industry pushes back against Trump’s drug pricing plan” – The Wall Street Journal
    https://www.wsj.com/articles/pharmaceutical-industry-pushes-back-against-trumps-drug-pricing-plan-2a5b9b28
  4. “ACLU sues Trump administration over transgender military ban” – NPR
    https://www.npr.org/2025/02/14/aclu-sues-trump-administration-over-transgender-military-ban
  5. “Analysis: The implications of Trump’s healthcare executive orders” – Politico
    https://www.politico.com/news/2025/05/13/analysis-the-implications-of-trumps-healthcare-executive-orders-00334167

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