President Trump was elected to challenge bureaucratic inertia and ignite American innovation — not to empower the same regulatory philosophy that hampered our national response during the COVID-19 pandemic.
Yet the recent appointment of Dr. Vinay Prasad to lead the FDA’s Center for Biologics Evaluation and Research (CBER) raises serious concerns about the direction of our nation’s health policy.
Dr. Prasad is not new to public discourse.
He's widely known for his critical views on accelerated drug approvals, emergency authorizations, and fast-track regulatory frameworks.
While his supporters describe him as a voice of caution and rigor, a closer look at his policy positions reveals a fundamental misalignment with the Trump administration’s agenda of bold, patient-focused, pro-innovation governance.
During the height of the COVID-19 pandemic, Operation Warp Speed — one of President Trump’s most successful initiatives — showed the world what's possible when government acts with urgency and confidence in American science.
Vaccines were developed in record time, critical treatments reached patients faster than ever before, and the FDA, under Trump’s leadership, was reshaped to reduce red tape and increase responsiveness.
By contrast, Dr. Prasad has been a consistent skeptic of that approach.
He opposed broad COVID-19 vaccine rollouts, including for vulnerable populations. He has argued against fast-tracked therapies for cancer, rare diseases, and other urgent conditions — claiming that "speed undermines trust."
He has voiced concerns about compassionate use and right-to-try policies, preferring more centralized control by regulatory authorities over decisions traditionally made by patients and their physicians.
Prasad’s philosophy prioritizes process over outcomes.
He seemingly believes in expanding layers of review, inserting caution at every stage, and trusting institutional consensus over entrepreneurial action.
That model might satisfy academic institutions and global health bureaucrats, but it fails to deliver results for the American people — especially those in urgent need of breakthrough treatments.
This is not theoretical.
Every regulatory slowdown has a cost.
Delays in approving cancer drugs, for example, don’t just postpone treatment—they can shorten lives. Red tape in biologics development doesn’t just inconvenience researchers — it denies hope to families waiting for cures.
President Trump understood this, which is why his administration redefined the FDA as a partner in progress, not a barrier to it.
The stakes are even higher as we enter a second Trump term. America’s global leadership in biotech is not guaranteed.
China is investing billions into its biomedical infrastructure. European regulators are vying to become the global standard-setters.
If the U.S. slows down now — if we revert to the "caution-first, innovation-later" mindset that Prasad has seemingly championed — we risk ceding ground in a sector that defines our future.
(Editor's Note: The preceding opinion column's views expressed are those of the author solely, and not of Newsmax.)
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.