The FDA Reforms

It is not every day that I compliment this administration, but mark your calendars, today is such a day. I visited the FDA website and I found it inspiring. I was greeted by a list of their accomplishments featuring 40 bullet points, separated in four categories: Food, Drugs, Public Trust and Modernizing the Agency, and a lot of it makes sense. The full list can be seen here.

Reform summary at the FDA

I selected a few points that are the most pertinent for the biopharma industry to discuss:

Initiated National Priority Vouchers

The idea is to prioritize products with significant potential to address a major national priority, defined as either 1) meeting a large unmet medical need, 2) reducing downstream health care utilization, 3) addressing a public health crisis, 4) boosting domestic manufacturing, or 5) increasing medication affordability. Those programs will get extra support from the FDA throughout development and are promised an accelerated review, with a response within 1-2 months after filing.

There seem to some overlap with existing prioritization approaches such as Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review, but if that brings more medicines to market quicker, I am all for it. I also like the idea of prioritizing medicines that will be manufactured un the US, as it could create more jobs in pharma. 

Cut Red Tape to Accelerate Biosimilars

The FDA's new guidance seeks to remove the requirement for biosimilars developers to conduct comparative human clinical studies, allowing them to rely instead on analytical testing to demonstrate product similarity.

Furthermore, switching studies, where sponsors alternate between originator and biosimilar (to claim interchangeability) will not be generally recommended. This is could significantly lower the price of biosimilars. 

Stopping Unnecessary Animal Testing

The agency wants to reduce or replace animal testing requirements with a range of approaches, including AI-based computational models, cell lines and organoid toxicity testing. This means using lab-grown human “organoids” and organ-on-a-chip to test drug safety. These experiments can reveal toxic effects that could easily go undetected in animals, providing a more direct window into human responses.

The roadmap also encourages sponsors to leverage computer modeling and artificial intelligence to predict a drug’s behavior.  

Boosting Domestic Pharmaceutical Manufacturing

The FDA PreCheck program was developed to promote domestic production of critical medicines by streamlining the review of those that will be produced in the USA. This program should improve regulatory predictability and shorten time-to-market.

The FDA will support the sponsors with more frequent communications at critical development stages and help them streamline the development and license application process through pre-application meetings and early feedback. This should have a positive impact in job creation in the pharma industry.

Unleashing Cutting-Edge Gene Therapies

FDA has leveraged its growing experience with Cell and Gene Therapy (CGT) products to implement regulatory flexibilities that accommodate the unique characteristics of these innovative therapies while maintaining rigorous quality standards.

This approach allows regulatory flexibility during clinical development, including relaxed compliance with full GMP requirements prior to late-phase trials, while encouraging ongoing engagement with reviewers as CGT manufacturing continue to rapidly evolve.

Cracking Down on Misleading Pharma Ads

This initiative will enforce a format for cable TV and online ads that will be more balanced and clearly highlights the downsides of the medications as well as the benefits. This will encourage companies to spend less on marketing and create more affordability. Coming from a different country, I must say that the drug commercials are ridiculous here. It plays into the anxiety of vulnerable segments of the population and encourages widespread drug overconsumption. This will not completely stop direct-to-consumer advertising, but any step in that direction is welcome.

Launched Internal AI Tool to Help FDA Employees Work More Efficiently

The tool is called Elsa and lives on a secure cloud-based environment engineered for safety and privacy. It is currently in use to assist reading, writing and summarizing documents to enable faster comparisons. The agency plans to integrate more AI in different processes to further support the FDA’s mission.

They claim to have successfully completed the first AI-assisted scientific review pilot in May 2025 albeit sparce details have been shared. The generative AI tool allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process. Everybody uses AI, so it makes sense for the FDA regulators to use it too. It is an interesting to follow as the sponsors and regulator increase their reliance on AI for regulatory submissions and approvals.

What Smart Pharma Companies Should do in 2026

• Design programs for what FDA is becoming, not the one you are used to. FDA is explicitly signaling trust in analytics, AI, and human-relevant models over default animal studies and redundant clinical trials. Companies that re-architect development around this reality will move faster and cheaper.

• Align portfolios with national priorities Priority vouchers and domestic manufacturing incentives make it clear: regulatory speed is now tied to unmet need, affordability, public health impact, and U.S. manufacturing resilience. Strategic alignment is becoming as important as scientific merit.

• Treat CMC as a strategic weapon. FDA’s flexibility for cell and gene therapies lowers early barriers but raises the bar later. The winners will be companies that invest early in process understanding, comparability, and manufacturing agility - long before regulators are forced to ask.