Dr. Vinay Prasad’s Reinstatement at FDA, a Blow to MAHA, and a Death Knell for ‘Right-to-Try’
The promise of “Right-to-Try” — signed into law under U.S. President Donald President Trump — was meant to provide terminally ill Americans access to experimental therapies when all else fails.
Under the “Make America Healthy Again” (MAHA) banner, we expected bold leadership that prioritized patient access, not political theatrics.
But now, Dr. Vinay Prasad’s reinstatement at the FDA is a disturbing signal that politics, not policy, drives our health reforms.
Prasad, who served as director of the FDA’s biologics division for less than three months, was forced out after ordering a shipment pause on Elevidys, the only FDA-approved Duchenne gene therapy.
The move inspired backlash from patient families and conservative activists — including Laura Loomer, who labeled him a “leftist saboteur.”
Now, after intervention from HHS Secretary RFK Jr. and FDA Commissioner Makary, a political win by alliance, he’s back in power—oversight resurrected by influence, not merit.
This reversal is not just a personnel matter.
It reflects a disturbing regression in how the FDA enacts — and can be swayed from — its own rules.
Investors responded predictably: Sarepta stock plunged 5.2%, Replimune lost 15.1%, highlighting the market’s fear that regulatory decisions now teeter on internal power plays.
Still, the regulatory fallout runs deeper. Prasad’s tenure oversaw the denial of promising gene therapies based not on safety, but needless technicalities:
- RP-1 (Replimune) met breakthrough thresholds and had a 33% response rate yet was rejected for “trial design heterogeneity.”
- Capricor’s deramiocel therapy was sandbagged — despite meeting endpoint goals — over manufacturing concerns met by the sponsor.
- Elevidys was abruptly paused, then partially reinstated only for ambulatory youth, leaving critically ill patients stranded — belied by MAHA’s pledge to empower suffering families.
These failures weren’t policy but inertia.
Prasad’s regressive approach placed form over function — derailing progress where science called for acceleration.
In rigged regulatory systems, timing becomes a death sentence.
MAHA’s mandate demanded no such barrier.
Now, with Prasad back, we face the certainty that deliberate process will trample patient urgency again.
If we want MAHA to mean anything, the following must happen immediately:
- Publish real-time CRL summaries—let the public know why a therapy is blocked before lives dissipate in ambiguity.
- Define clear, objective Right-to-Try eligibility criteria, beyond vague “case-by-case” catchphrases — failure to define is betrayal.
- Enforce expedited review protocols for terminal-use therapies, with performance metrics and accountability for missing deadlines.
This reinstatement is not a policy reset; it’s a Brand narrowing of hope. Patients and innovators need consistency — not resumes staged by political patronage.
Let’s be clear: public health policy and regulatory leadership cannot be passengers to internal factionalism.
If the FDA functions by balance of influence — not evidence-based outcomes — then MAHA’s legacy is reduced to optics. And that betrayal costs lives.
The Right-to-Try is not a slogan.
It’s a survivor’s lifeline. If opponents can hijack it so easily, then we must reclaim it — through reform, not rhetoric.
Lives hang in the balance. MAHA must respond — or become a political footnote.
Charlie Kolean has worked as a senior policy adviser for state legislators, multinational corporations, and think tanks. Mr. Kolean has been involved in politics for over a decade as an activist, candidate, political consultant, and party leader. He was a bundler on the Trump Finance Victory Committee, and is a member of the American Association of Political Consultants. Read more of his reports — Here.
© 2025 Newsmax. All rights reserved.
