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# Woodcock Urges Stronger FDA Role in Updating Generic Labels
- URL: https://www.fdaweb.com/woodcock-urges-stronger-fda-role-in-updating-generic-labels/
- Published: 2025-11-21T12:00:00.000Z
- Updated: 2026-09-14T15:27:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160262

Former FDA principal deputy commissioner **Janet Woodcock** and policy experts from Duke University are calling on the agency to adopt new tools and pathways to support evidence-based drug repurposing, arguing that the current system — built around commercial drug sponsors — prevents many proven new uses of generic medicines from ever reaching patients.

In a guest [commentary](https://www.biocentury.com/article/657654/fda-should-take-a-more-active-role-in-updating-drug-labels-when-there-s-strong-evidence?ref=fdaweb.com) published on *BioCentury*, Woodcock, **Beth Boyer**, and **Mia Williams** of the Duke-Margolis Institute for Health Policy said the U.S. regulatory framework leaves non-traditional developers such as academics, patient groups, and nonprofits without a viable route to update drug labels, even when strong clinical evidence supports a new use. Without label updates, insurers often decline coverage, clinicians may be unaware of emerging evidence, and patients lose access to potential therapies, particularly in rare diseases.

“Every year, promising new uses for generic drugs emerge … yet most never reach patients,” the authors wrote, attributing the gap not to science, but to regulations designed for for-profit pharmaceutical companies. With most generics offering little commercial return, drugmakers rarely invest in repurposing studies, leaving much of the work to groups that lack regulatory expertise and resources.

The commentary highlights success stories — such as sirolimus for autoimmune lymphoproliferative syndrome — but says repurposing remains “underused” despite its potential to lower drug costs, accelerate treatment development, and address unmet needs in rare diseases.

Woodcock and her coauthors outlined three major steps FDA could take:

**1\. Expand education and guidance for non-traditional developers**

The authors urged FDA to establish dedicated programs, workshops, and advisory support to help academic and nonprofit groups design studies and assemble data in line with regulatory expectations. But they noted that without a new regulatory mechanism, these groups would still need industry partners to pursue label changes.

**2\. Create alternative regulatory pathways**

They proposed new options that would allow non-traditional developers to independently seek label updates without having to generate chemistry or manufacturing data already held by FDA. One model, a “labeling-only” pathway, would permit developers to reference existing generic drug files. Another possibility is formalizing a process to use citizen petitions to prompt FDA scientific reviews that could lead to public notices endorsing new uses. They also suggested piloting a “Repurposing Evidence Pathway” — a staffed review program dedicated to evaluating strong evidence for new indications of generic drugs.

**3\. Launch a coordinated federal repurposing initiative**

Under a broader HHS-led effort, health agencies could collaborate to fund and conduct repurposing trials, develop standardized protocols, and ensure that Medicare and Medicaid would cover FDA-endorsed new uses. Such an initiative could focus on areas of high public health need.

The authors said these reforms would not lower FDA’s evidentiary standards, but would modernize outdated processes that prevent effective treatments from reaching patients.

Woodcock, who spent nearly 40 years at FDA, said repurposing offers the government a chance to deliver “faster, cheaper treatments” without sacrificing safety. Updating drug labels when strong evidence exists, she said, aligns with FDA’s public health mandate.

The authors concluded that unlocking the full potential of generics will require a cultural shift at FDA and recognition that the agency must support not only traditional pharmaceutical sponsors, but also the growing number of patient-driven and academic efforts to advance new uses for existing drugs.