The Food and Drug Administration has rehired controversial Dr. Vinay Prasad as the head of the center that regulates vaccines and biotech therapies after he was fired pursuant to an order from the White House.
Leading up to his firing, Prasad made many controversial decisions, and the White House was fed up with his obstruction of medicines and therapies used by patients with life-threatening conditions. As a result, many felt that Prasad undermined President Donald J. Trump’s landmark “Right to Try” legislation. Now that he has returned to the job, it makes sense for Prasad to use his great knowledge of biologics to expedite lifesaving medicines and therapies in an effort to repair his image.
President Donald Trump’s Right to Try Act, signed into law in 2018, is one of his first-term legacy achievements. The FDA describes the act as “one way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain investigational treatment options.” These options can only be accessed by patients with serious or life-threatening diseases or conditions. The law allows these patients to access “eligible investigational drugs.” However, if bureaucrats are obstructing access, then the law is ineffective.
When the law was passed, there was great hope among stakeholders that terminally ill patients would have the freedom to make their own choices about drugs and therapies without government obstruction.
The Competitive Enterprise Institute argued on May 21, 2018, that when the law passed, “patients only [had] access to drugs that have been approved by the FDA.” Thirty-eight states had enacted right-to-try laws that allowed “patients to have greater control over their own lives,” because these laws granted “terminally ill patients who cannot participate in clinical trials and have exhausted all other options access to medical treatments which have not yet received FDA approval.” A doctor administers these treatments and has passed a screening process. Terminally ill patients now have the right, if the FDA does its job, to make choices with expanded options.
One red flag that made Prasad a problem for the White House was his earlier opposition to Trump’s Right to Try Act. The Wall Street Journal reported on July 27, 2025, that Prasad’s prior writings have “long criticized the FDA for approving too many treatments that, in his view, provide only marginal benefits. He’s also lambasted President Trump’s first-term ‘right to try’ law, which lets terminally ill patients try experimental drugs not yet approved by the FDA.”
The president sent a strong message by removing Prasad, and the hope is that this act motivated Prasad to reverse course and implement a law he once criticized.
The Trump administration’s Presidential Personnel Office has done an excellent job of screening and putting in place the right people to implement President Donald Trump’s promises. Whether you agree or disagree with the President on the issues, one look at his Cabinet reveals he hired Secretaries who reflect the President’s views. Once Prasad’s history and actions at the FDA were studied, President Donald Trump “drove the push to oust the FDA’s top vaccine regulator, four people with knowledge of the decision,” reported Politico. FDA Commissioner Marty Makary convinced the president to hire him back.
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The FDA needs to dial back the idea of an unfair regulatory attitude as the Trump administration tries to rid the federal government of redundant, obsolete, and harmful regulations. Trump announced on January 31, 2025, a 10-to-1 deregulatory initiative. He signed an executive order that mandated “whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed.” The Office of Management and Budget was tasked to ensure standardized measurement and estimation of regulatory costs. The EO required that for fiscal 2025, the total cost of all new regulations, including repealed ones, be less than zero. This reversed the policy of the Biden administration that imposed $1.7 trillion in regulatory costs on the American people.
Now is the time for the FDA to support the law’s implementation as written and take actions favorable to patients suffering from these terrible diseases. The hope is that Dr. Prasad and Commissioner Makary learn their lesson and move forward with a view of regulation and the Right to Try Act that conforms with the president’s vision.
Peter Mihalick is a former legislative director and counsel to two Republican members of Congress.