32TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 REGULATION Recent policy changes by the Trump administration have presented both challenges and opportunities for the biotechnology and pharmaceutical industries, which are facing up to the prospect of a 25%+ hike in tariffs this year – a measure aimed at boosting domestic production. The tariffs imposed on the drug industry are the latest in a series of actions designed to accelerate innovation and reduce costs. Longer-term reforms also intend to fast-track drug approvals and relax regulatory oversight of digital health tools, But the policy shifts have been met with both praise and concern, not least the US Food and Drug Administration’s (FDA) increasingly flexible approach to drug approvals. Reforms such as the expanded Accelerated Approval Pathway (AAP) and a push for adaptive clinical trial designs have allowed pharmaceutical companies to bring treatments to market more quickly. The question now is whether these policies are creating a more efficient, innovation-driven regulatory framework—or if they risk undermining critical safeguards designed to protect public health. AAP as a priority The AAP ensured that Aduhelm (aducanumab), a drug used to treat Alzheimer’s was approved in 2021 despite question marks over its efficacy and reliance on amyloid plaque biomarkers rather than clear cognitive improvement. Likewise, new cancer immunotherapies, such as pembrolizumab received accelerated approval for multiple indications based on biomarker-driven data. Other notable regulatory changes place an emphasis on digital health and innovation, in which concerted efforts have been made to pushed for greater integration of digital health tools and telemedicine within regulatory frameworks. By promoting a more flexible approach, the FDA have been able to keep pace with rapid technological advancements. “We [the FDA] have a lot of quantitatively gifted people and people with experience in digital technologies and computing at every level,” said ex-FDA Commissioner Robert Califf, MD in a 2024 interview published in JAMA. “…there are whole new areas that we’re going to have to stay abreast of. It’s very well understood that it’s
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