Terminal Patients Deserve Autonomy Over FDA Paternalism in Treatment Access
Source: "Patients with rare diseases need an FDA partner, not another gatekeeper | Fox News." September 28, 2026. www.foxnews.com
The Gist
A 25-year-old with a fatal muscle-wasting disease argues that the FDA should stop acting like an obstacle and instead become a partner to patients like him who are running out of time. He says if he and his doctor agree a risky, unproven treatment is worth trying, the FDA shouldn't be the one to say no—and he wants the next FDA leader to actually listen to patients instead of just regulating from a distance.
Conclusion
The next FDA commissioner should adopt a patient-centered philosophy that grants patients with terminal or rare diseases—together with their doctors—greater authority to decide on acceptable treatment risks, rather than having the FDA act as the final gatekeeper.
Premises
- Patients with progressive, terminal diseases like Duchenne muscular dystrophy face constant loss of function and time; every year of regulatory delay causes irreversible harm.
- When a patient understands the risks, their physician understands the risks, and there is real evidence a treatment could help, the regulatory system should lean toward partnership rather than paternalism.
- Congress has already recognized this principle through the Right to Try Act (2018) and is seeking to extend it further through Right to Try 2.0.
- The FDA's own accelerated approval pathway demonstrates that the agency already acknowledges that waiting for traditional clinical endpoints can cost patients irreplaceable time.
- Practical burdens of accessing treatment (e.g., traveling for clinical trials) compound the harm of a slow, centralized regulatory system for patients who are physically deteriorating.
- Patients living with these diseases possess direct, lived expertise about their conditions that should inform FDA policy and personnel decisions, not just outside clinical data.
Assumptions
- Patients facing terminal or severe rare diseases are capable of making informed decisions about acceptable risk levels for experimental treatments.
- Physician and patient agreement on risk provides an adequate safeguard against harm, reducing the need for centralized regulatory approval.
- Greater patient autonomy in treatment access will lead to net positive outcomes rather than exploitation or false hope.
- The current FDA culture is more paternalistic than necessary given existing scientific and clinical evidence standards.
- Personnel choices (such as appointing a biotech-experienced deputy commissioner) will meaningfully shift FDA culture toward patient-centered practices.