Fentanyl was originally synthesized in the 1960s as a medical opioid for severe pain and anesthesia, but today its illicit form dominates the U.S. opioid supply. Its extreme potency means that a lethal dose can be as little as two milligrams, making it highly dangerous. Because fentanyl is synthetically produced, there are no crop or seasonal limitations, allowing for year-round manufacture. The low cost of production means millions of doses can be created from just a few kilograms of precursor chemicals. Additionally, its easy distribution—tiny quantities can be shipped in envelopes, vehicles, or mail—makes it especially attractive to traffickers and difficult for authorities to intercept.

While Patient-Focused Drug Development (PFDD) has elevated the patient voice in healthcare, significant gaps remain in translating these insights into measurable outcomes. True patient centricity goes beyond consultation—it requires embedding patient perspectives into every stage of drug development, from trial design to post-market evaluation. Yet, challenges persist: inconsistent patient engagement, lack of standardized metrics, and limited frameworks to assess the impact of patient input on decision-making. Measuring the success of patient-centric initiatives demands clear indicators, such as improvements in patient-reported outcomes, enhanced treatment adherence, and tangible changes in clinical or regulatory decisions. Only by identifying these gaps and establishing robust metrics can we ensure that patient-centered strategies deliver meaningful results rather than symbolic gestures.

More than a decade after the Affordable Care Act expanded coverage for millions, a harsh reality remains: coverage does not equal access. Premiums continue to rise, rural care deserts are widening, and consolidated insurers and middlemen dominate every layer of the system. In this article, I explore the ACA’s most overlooked weakness—its failure to confront the structural barriers that suppress competition. From Certificate-of-Need laws to PBM pricing distortions and marketplace consolidation, these forces inflate costs and restrict care long before patients reach the exam room. To achieve true affordability and access, we must finish the job the ACA started by opening the system to innovation, transparency, and competition.

COVID-19 exposed a fragile pharmaceutical supply chain — hollowed out by decades of offshoring and rising costs. Today, the U.S. faces a choice: rebuild domestic drug manufacturing or remain dependent on foreign factories. A bold, practical solution is emerging — National Centers of Excellence for Pharmaceutical Manufacturing — shared regional hubs that provide GMP-certified facilities, workforce training, and surge capacity to ensure secure, affordable medicines made on American soil. Supported by President Trump’s recent Executive Order to restore domestic production, these centers could revive our industrial base, protect national security, and make drugs more accessible. The next crisis won’t wait — and neither should we.

Drawing on her experience as rare disease patient advocacy group SYNGAP1 Foundation’s founder and former president, Monica Weldon argues for the need to standardize genomic testing practices, warns against the possible ethical implications of individualized medicine, and makes a cause for a more holistic approach within rare disease communities.

The Promising Pathways Act 2.0 is a newly proposed bill that aims to expedite and streamline approval pathways for rare disease therapies in the US. The Act is, however, facing a number of challenges in terms of implementation. The sponsors of these niche therapies tend to be small and medium-sized biotech firms which are unable to compete with the financial might of Big Pharma and also struggle to deal with the myriad regulatory hurdles they need to jump over. Monica Weldon, a frequent PharmaBoardroom contributor and rare disease patient advocate, who helped craft the bill, explains more.