The Food and Drug Administration rehired controversial Dr. Vinay Prasad as the head of the center that regulates vaccines and biotech therapies. Leading up to his firing, he made many controversial decisions, and the White House was fed up with his obstruction of the use of newly developed medicines and therapies to be used by patients with life-threatening conditions. As a result, many felt Prasad undermined President Donald Trump’s landmark Right to Try legislation. Now that he has returned to the job, it makes sense for Prasad, in an effort to repair his image, to use his great knowledge of biologics to expedite those lifesaving medicines and therapies. Doing that means resolving pending reviews in which safety isn’t the sticking point and moving with clarity on programs already deep in dialogue with the agency, such as oncolytic immunotherapies with Replimune’s RP1 in melanoma and rare-disease candidates such as Stealth BioTherapeutics’ elamipretide for Barth syndrome.
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, when the review process drifts or becomes unpredictable, patients lose access for reasons unrelated to science. The fix is timely, science-based decisions on therapies in the accelerated approval pathway. Right to Try should remain a narrow backstop for patients, with an emphasis on timely FDA approval of effective therapies so patients don’t have to rely on workaround pathways.
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 the drugs and therapies without government obstruction. The Competitive Enterprise Institute argued on May 21, 2018, that at the time 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.” These treatments are administered by a doctor and have passed a screening process. Terminally ill patients now have the right, if the FDA does its job, to make choices with expanded options, with the safest path of completing the reviews already on the docket and publish decisions promptly, rather than forcing families to rely on emergency workarounds.
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 in the first place, and the hope is that this act motivated Prasad to reverse course and implement a law he once criticized. Revisiting recent FDA rejection decisions, such as RP1 in melanoma and elamipretide for Barth syndrome, with which FDA concerns have already been engaged, is an immediate opportunity to show the agency can be exacting and responsive when patients face life-altering diseases.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
The FDA needs to keep standards high while closing well-supported applications without long and unnecessary regulatory steps, in line with the Trump administration’s effort to streamline regulations to rid the federal government of redundant, obsolete, and harmful regulations. Trump announced on Jan. 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 order required that for fiscal 2025, the total cost of all new regulations, including repealed ones, be less than zero.
Now is the time for the FDA to take actions favorable to patients suffering from terrible diseases. That means moving applications forward when the evidence is there and not letting reviews stall. Families waiting on decisions are watching closely as programs sit on the agency’s desk. Prasad and Commissioner Marty Makary should prove they’ve learned from past missteps by focusing on timely approvals, with Right to Try serving as the safety valve the president envisioned it to be.
Peter Mihalick is a former legislative director and counsel to two Republican members of Congress.
