At the intersection of medicine and governance, recent events have exposed a fragile infrastructure supporting the US pharmaceutical system. Regulatory agencies once viewed as technocratic strongholds now find themselves entangled in political reshuffling, leadership voids, and legal uncertainty.

The FDA’s inaction on vaccine approval, the FTC’s paralyzed insulin price lawsuit, and ongoing battles over drug affordability reveal more than isolated disruptions, they reflect a system negotiating its authority, priorities and limits.

In a field where delays can cost lives and access is shaped by institutional resolve, these developments remind us that the architecture of health policy is only as strong as the values and vigilance that sustain it.

Insulin lawsuit paused

The Federal Trade Commission (FTC) has suspended its high-profile lawsuit against three major pharmacy benefit managers, CVS Caremark, Express Scripts, and Optum Rx, citing an inability to proceed after President Donald Trump fired two of the agency’s Democratic commissioners.

The remaining Republican commissioners, both rescued from the matter, leave the agency with no eligible members to oversee the case. Originally filed in 2024, the suit accused the PBMs of driving up insulin costs by pocketing rebates from manufacturers while promoting higher-priced versions to consumers.

The 105-day stay effectively halts what been a central element of a Biden-era crackdown on PBM business practices. The case’s pause arrives alongside broader concerns about the FTC’s operational capacity, as budget constraints and political reshuffling slow enforcement across key sectors.

In 2024, the agency had published critical reports on PBM conduct, and the case was expected to test the strength of antitrust tools in curbing middlemen’s influence in pharmaceutical pricing. While some lawmakers continue to push PBM reform through legislation, the litigation’s indefinite pause offers breathing room for an industry long accused of distorting drug markets.

Critics, including former FTC Chair Lina Khan, argue the delay plays directly into PBMs’ hands. As the Trump administration moves to reshape independent agencies through firings and tighter executive control, the case’s future now hinges less on legal merit and more on political will.

Temporary tariff reprieve

President Trump’s sweeping trade strategy overhaul introduced a 10% blanket tariff on imports, with sharper country-specific rates looming. For now, finished pharmaceutical products are exempt, offering brief relief to the industry and prompting a modest stock bump for companies like GSK and AstraZeneca.

But the grace period may be just that: temporary. Future levies, including a possible 25% tariff on drug imports, have been floated, and any move to include pharmaceuticals could upend long-standing protections under WTO rules. Meanwhile, ripple effects from broader tariff policies, rising input costs, supply chain instability, and geopolitical retaliation, are already taking shape.  

For drugmakers, supply chain vulnerability is the real pressure point. With 90% of US biotech firms dependent on foreign inputs for key therapies, tariff shocks risk disrupting production and delaying access to medicines. The industry is already navigating tightened pricing rules under the Inflation Reduction Act, and the added costs of reshoring could compress margins further.

Meanwhile, ongoing cuts to federal science funding are fueling a brain drain, with skilled researchers migrating to better-funded programs abroad. Even as the US pushes for greater manufacturing independence, its research ecosystem risks erosion.

For now, the pharmaceutical sector has dodged a direct hit, but the cracks are forming fast, and resilience alone may not hold.

Drug price ruling

A federal judge has dismissed Amgen’s lawsuit against Colorado’s Prescription Drug Affordability Review Board, ruling that the pharmaceutical giant failed to show it would suffer direct harm from the state’s potential cap on Enbrel, a biologic drug used to treat arthritis.

The ruling marks a temporary win for Colorado as it prepares to become the first state to formally set an “upper payment limit” (UPL) on a prescription medication it deems unaffordable. Amgen had argued that the upper payment limit would hurt its bottom line by forcing upstream price cuts, but the court found those claims speculative at best.

Judge Nina Y Wang emphasized that Colorado’s price cap would apply not at the manufacturer level, but at the point of sale to consumers, affecting how much patients, insurers, or pharmacies could pay, rather than what Amgen can charge its distributors.

In her decision, she clarified that the law targets transactions further down the supply chain, thus placing it outside the realm of direct regulation for manufacturers like Amgen. Because of this, the court concluded that Amgen lacked the standing to challenge the statute’s constitutionality.

“Instead, a UPL applies directly only to downstream transactions for the actual sales and reimbursements of the prescription drug dispensed to Colorado consumers.”

Judge Wang, District Court for the District of Colorado

While the court’s decision doesn’t close the door to future challenges, and Amgen may revise and refile its complaint, it does strengthen the legal footing of Colorado’s affordability board at a critical moment. As rulemaking proceeds, all eyes remain on how the state balances affordability, access, and innovation in what could become a national model for drug price regulation.

Insider trading

Compliance is not an accessory, it is an armor that shields markets from erosion. The SEC’s recent action against George Demos, former Vice President of Acadia Pharmaceuticals, underscores the weight of this principle.

Demos, entrusted with confidential FDA communications as a core member of the company’s drug labeling team, allegedly exploited material nonpublic information for personal financial gain. The SEC’s complaint charges Demos with violating Section 17(a) of the Securities Act of 1933, and Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder.

When the FDA failed to provide expected feedback on Acadia’s supplemental application for its Parkinson’s psychosis drug, Demos reportedly drew the only conclusion someone with his access could: the news would be negative.

Before the public announcement, he exercised and sold nearly all his vested stock options, avoiding $1.3m in losses ahead of a 45% stock plunge. The implication extend far beyond one man’s trades, they threaten the market’s foundational presumption of fairness.

While the nature of inside information varies, from subtle signals to undeniable warnings, those who trade on such knowledge tip the balance of trust and transform information into a weapon. Demos was not just a passive observer to delayed FDA communications; as part of the labeling team, he understood their gravity and timing.

In a financial ecosystem that depends on clarity and candor, there is no safe harbor for those who engineer deception from within. Whether through round-trip cash schemes or silent trades on inside knowledge, manipulation, be it flamboyant or calculated, strikes the heart of public trust.

FDA delays Novamax decision

The Food and Drug Administration (FDA) has missed its April 1 deadline to decide on full approval for Novamax’s COVID-19 vaccine, just days after the abrupt departure of Dr Peter Marks, the agency’s top vaccine official.

While Novamax’s shot remains available under emergency use authorization, full approval would have solidified its role in post-pandemic immunization strategies, especially for those preferring alternatives to mRNA vaccines.

According to The Wall Street Journal, draft approval materials had already been prepared and circulated internally, but the decision has stalled amid rising political scrutiny and tightened oversight from the Department of Health and Human Services under Secretary Robert F Kennedy Jr.

Sources familiar with the matter suggest that mounting delays are tied not only to leadership turnover but also to ongoing funding and staffing constraints that have slowed review process across the FDA.

Increased political intervention, including the requirement that all vaccine-related communications be cleared by senior Department of Health and Human Services staff, has further complicated the agency’s ability to act independently.

As trust in science-based regulatory decisions hangs in the balance, Novamax’s pending application has become a litmus test for the future of US vaccine policy.