Op-ed views and opinions expressed are solely those of the author.

Biotech advancements often face delays due to bureaucracy, hindering the development of necessary therapies. Now is the time for us to overhaul the archaic procedural measures, including the Food and Drug Administration’s (FDA) outdated policies and procedures.  If we continue to permit bureaucracy to impede the advancement of science, then people will continue to die waiting for therapeutic advances – and that is unacceptable.

With over 30 million Americans suffering from rare diseases, 95% of whom lack approved treatments, time is of the essence. FDA approvals typically take a decade and require extensive funding, plagued by lengthy reviews and outdated standards. These patients have no options.

Our understanding of diseases and technologies has advanced substantially over the past decade, but FDA regulations haven’t changed much.  It’s imperative that our regulatory policies align with our scientific potential.  

To modernize the FDA, three key changes are crucial. First, regulatory guidelines must reflect current scientific progress. The last major update occurred over 30 years ago, while technologies like AI and gene editing have significantly advanced. Current standards often rely on outdated methods, such as in vitro testing over AI predictions and animal testing for human antibodies, which lack scientific logic. Regular guideline reviews are essential to align with technological advancements.

Second, depoliticizing the FDA is vital. Personal politics should not influence drug approvals, yet vague definitions like “reasonably likely to predict clinical benefit” in Accelerated Approval processes have allowed biases to sway decisions. The inconsistent application of these processes, such as the denial of rare disease approvals under one director and subsequent approval under another, highlights this issue. Scientific data should drive regulations, and oversight is necessary to remove personal bias.

Third, bringing humanity to the FDA means connecting decision-makers with patients. Many FDA team members have never met individuals affected by the diseases for which they evaluate treatments. This is especially true for desk scientists and groups like the Clinical Outcome Assessments, who make critical decisions without real-world patient interaction. Every FDA team member involved in drug approval should meet at least one patient to understand the human impact of their decisions.

These changes will accelerate drug development, reduce costs, and positively affect patients globally. By embracing progress and prioritizing patient needs, lives can be saved.

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Dr. Shoshana Shendelman

Dr. Shoshana Shendelma, PhD is a scientist and entrepreneur who has founded numerous biotech companies. She is a pioneer in the development of drugs and therapeutics for rare and underserved diseases. Currently she is Vice Chair of the Clinical Advisory Board of Columbia University Medical Center and Columbia University Vagelos College of Physicians and Surgeons.

Latest posts by Dr. Shoshana Shendelman (see all)

• Now is the time to modernize the antiquated FDA - May 13, 2025

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