On the campaign trail, President-elect Trump ran on his record of expanding consumer and patient choice. He even went out of his way during his debate with President Biden to tout a 2018 law he signed giving terminally ill patients a "Right to Try," promising medications unapproved by the Food and Drug Administration (FDA). However, it remains unclear whether the President-elect will push the notoriously risk-averse FDA to get its act together.

Key Trump allies such as Robert F. Kennedy, Jr. (RFK, Jr.) seem to want even more FDA rules, despite scant evidence that costly regulations have made things any safer for consumers. The new administration should put consumers and patients first and reject calls for more red tape at the FDA.

It's hard to square the Trump deregulatory agenda with allies' muddled messaging on FDA reform. RFK, Jr., who the President-elect will nominate to lead the Department of Health and Human Services, believes too many medications with safety issues are being approved due to the unwarranted clout of pharmaceutical companies. He claims user fees place "bureaucrats' purse strings in the hands of the pharmaceutical industry," resulting in a free-wheeling regulatory environment. This "Wild West" idea of drug approvals is not rooted in reality. Between 2017 and 2023, the FDA issued more than 230 denials of drug applications, citing everything from labeling issues to manufacturing deficiencies. Only 10 percent of medications that have made it to preliminary clinical trials will ever see the shelves of a pharmacy. In other words, there is no corporate-sponsored "golden ticket" to drug approval.

It's only reasonable to ask why so many medications are rejected by regulators. A few examples from recent years shine light on a deeply dysfunctional process. One poorly reasoned rejection centered around a medication called omburtamab, designed to treat a rare pediatric brain cancer. Agency officials expressed concern that the datasets used to study the drug were too old to be reliably interpreted, even though the FDA acknowledged that, according to the evidence, patients taking omburtamab live 7-12 months longer than their non-medicated peers.

In January, the agency axed a drug called zolbetuximab, which holds significant promise in treating gastric/gastroesophageal cancer. The issue with the medication was neither safety nor efficacy, the two traditional benchmarks for drug approval. According to clinical trial results, the medication improved median progression-free and overall cancer survival by 2-3 months compared to just chemotherapy. The drug was held up because of "unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility."

These supposed "deficiencies" were not an issue for the Japanese Pharmaceuticals and Medical Devices Agency, which green-lit the drug in March. It took the FDA seven months after the Japanese approval to finally grant American patients access to the life-extending medication. In its October 18 press release announcing the approval, the FDA boasted that the application "was granted priority review, fast track, and orphan drug designation." When the U.S. is still falling behind international approval times even after applying three different types of preferential treatment, there is clearly a need for reform.

Meanwhile, drugs granted interim accelerated approval have been closely scrutinized by the FDA before being granted full approval. According to a 2022 study published in the journal Therapeutic Innovation & Regulatory Science, only 14 out of 167 (8.4 percent) medications granted accelerated approvals by the FDA between 2012 and 2021 were withdrawn from the market. Far more medications (51) were ultimately granted full approval by the agency following large-scale evidence confirming the medications' clinical benefits. The study authors conclude, "the accelerated approval program has been largely successful... recent FDA actions show that the agency is appropriately managing the program when a drug approved under accelerated approval fails to confirm a clinical benefit."

The FDA should expand its accelerated approval programs and critically examine flawed drug rejection decisions. The Trump administration could kickstart this process, but only with the right agency leadership with the right mentality. President-elect Trump can make America healthy again by rejecting calls for greater regulation.