Good help is hard to find—but not impossible. So why did the Food and Drug Administration tap a Fauci-praising, anti-Trump liberal as its chief medical officer?
Last month, Dr. Vinay Prasad was named the FDA’s Chief Medical and Scientific Officer—a bizarre appointment for someone who publicly attacked President Trump and praised Anthony Fauci. After an increasing chorus of voices called for his removal, he has, thankfully, stepped down. Now we have a chance to fix what he broke.
More importantly, Prasad’s appointment contradicted President Trump’s mission of maintaining America’s dominance in the global biotech industry. Since these misguided personnel choices, the domestic biotech market has suffered. The administration’s own “Make America Biotech Accelerate” (MABA) messaging rings hollow when the very regulatory pathways that accelerate treatments are under attack from within.
Biotech is a critical industry, whose economic value—and capacity to save lives—cannot be lightly sacrificed. American biotech companies are increasingly looking overseas due to concerns about the FDA’s ability to meet deadlines and provide regulatory clarity. That means capital and investment dollars are being “offshored” when they should be staying right here in the United States.
Biotech valuations are in freefall, with the sector’s leading index trading at less than half its 2021 peak. Nearly 30 percent of small and mid-cap biotech firms are now trading at or below their cash value. Mass layoffs are accelerating: more than 14,000 job cuts were reported in 2024, with many more expected.
There are growing reports of U.S. biotech executives expanding into European markets due to the uncertainty of domestic regulation. Europe’s clinical trial share, which had fallen from 22 percent in 2013 to 12 percent in 2023, is now rebounding. Just last week, the FDA blocked Capricor Therapeutics’ muscular dystrophy treatment from advancing to clinical trials. In response, investors are now eyeing the European Economic Area as a more reliable regulatory environment, one now attracting a “sizable chunk” of American talent and funding.
European and Australian clinical trials can reduce costs by 30 to 40 percent compared to U.S.-based trials. With clinical trials costing anywhere from $161 million to $4.5 billion, those savings are too large for shareholders to ignore.
Losing biotech market dominance to allies is bad enough—but losing it to adversaries is unacceptable.
As we learned during the COVID lockdowns, outsourcing key components of our biotech supply chain is a form of medical malpractice—especially when we outsource to hostile nations. China’s biotech sector expanded from less than 1 percent of global venture capital funding in 2010 to 15 percent in 2019. Its clinical trial footprint jumped from 9 percent in 2017 to 29 percent in 2023.
Just this week, Chinese firm GenAssist announced its entry into the gene-editing market, citing “regulatory setbacks” in the United States. At the same time, Sarepta Therapeutics halted shipments of its muscular dystrophy treatment due to FDA interference. With China still refusing to take responsibility for unleashing the coronavirus, do we really want to cede biotech leadership to Beijing?
These trends have accelerated under weak leadership at the FDA—and it’s leadership that the agency desperately needs.
Dr. Prasad has openly criticized the accelerated approval pathways that are crucial for rare disease treatments. Meanwhile, the FDA has lost experienced advocates like Dr. Peter Marks, who was a longtime champion of expedited drug approval. MABA’s global potential is projected to reach $30 trillion by 2040. So why would we sabotage it from within?
Progressives like to portray themselves as defenders of democracy, but they lost the 2024 election. The American people decided they don’t get to be in charge. So why would this administration appoint someone to a critical leadership role who didn’t even support it?
Good help is hard to find—but at least now, there’s an opening for someone better.