President Trump has been clear about his goals to unleash the greatness of American industry, create life-saving medicines at a rapid pace, and empower Americans to make their own health choices. While former FDA Commissioner Marty Makary was misaligned, the Trump administration should ensure the next person to take the role is focused on this vision for America.
Makary spent years rightly criticizing the medical establishment's COVID-era failures and promised to cut through FDA bureaucracy to get life-saving drugs to patients faster. Instead, the FDA only approved 46 drugs in 2025, lower than every year in the last decade except 2022.
The Commissioner also reversed previous FDA guidance, pulling the rug out from under American companies seeking to treat rare diseases like erythropoietic protoporphyria, Hunter syndrome, and Sanfilippo syndrome. In one case, the FDA told gene therapy company uniQure it "no longer agrees" that a previously approved study plan would support approval of a Huntington's disease treatment.
Amidst the regulatory chaos, the FDA had also been missing its review deadlines for drugs. Last summer, the agency got a lot of attention when it failed to meet its deadline, delaying KalVista's oral treatment option, Ekterly, for acute attacks of hereditary angioedema (HAE).
There have been quantifiable consequences of this regulatory uncertainty. Shares of biotech firms have declined sharply due to investor concerns. Biotech companies had 190 layoff rounds by the end of Q3 2025 and130 biopharmaceutical companies have cut 13,470 jobs. Capital flowing into U.S. biotech companies was down 57% year-over-year, and by the middle of last year only seven biotech companies had managed to go public year-to-date (compared to the 30 - 40 IPOs that would signal a healthy sector).
The next FDA Commissioner must lay out a plan to reverse these trends, promising to better run this crucial agency. After all, these trends are all occurring against a backdrop of rapidly accelerating Chinese biotech ambition.
Reduced U.S. investment in drug development does not occur in a vacuum, but against a backdrop of rapidly accelerating Chinese biotech ambition. The Information Technology and Innovation Foundation notes that while clinical trial activity in China doubled over four years, the U.S. only saw a 10% increase. While Chinese oncology trials grew 146% over four years, U.S. oncology trials grew just 1.56%. China went from 5.6% of global value-added pharmaceuticals output in 2002 to 24.2% in 2019. From 2013 to 2023, Chinese biotech PCT patents increased by 720% while American entities awarded patents only increased by 67%.
If the future’s most important cures are made by and controlled by the Chinese government, the security concerns are existential. While China is heavily subsidizing its industry, we cannot continue to handicap ours.
Beyond drug approvals, Commissioner Makary, in his role, also revived the FDA paternalism that Americans have long resented and that Congress has repeatedly been asked to rein in. Under his tenure, the agency targeted flavored nicotine products – policing Americans' personal health choices while failing in its primary duty of approving safe and effective medicines.
Directly against the President’s wishes, Makary initially refused to authorize blueberry and mango vape flavors from a Los Angeles manufacturer. This displayed poor judgment in several ways. First, he went rogue, ignoring the directives from his (elected) boss. Second, flavored vapes are highly effective in reducing addiction to more harmful products. Third, these bans only create more demand for a flood of illegal Chinese vapes.
The next FDA Commissioner should assure the American people that he or she will carry out President Trump’s vision, not tell them how to live.
There is nothing groundbreaking or anti-establishment about the way the FDA was run under Makary, who was promised to be “different.” In fact, this is the same paternalistic, Washington-knows-best ideology that has plagued the federal government for decades. These are the same heavy-handed tactics that have always pitted industry against its regulators.
The American people deserve better. They deserve a commissioner with a simple mission: approve safe and effective drugs quickly, keep the agency out of Americans' personal choices, and solidify the United States’ position as leader in biotech and biopharma innovation.
Isabelle Morales is Director of Health Policy at Americans for Tax Reform.
