Pharma, Policy

Right-to-try law intended to weaken FDA, bill’s author tells agency commissioner

The law, which President Trump signed this week, allows patients to receive experimental drugs without FDA oversight.

The author of the recently signed right-to-try bill stated in a letter to the Food and Drug Administration’s commissioner that the law was intended to diminish the agency’s regulatory oversight.

In the letter, addressed to FDA Commissioner Scott Gottlieb, Sen. Ron Johnson, R-Wisconsin, wrote, “[This] legislation is fundamentally about empowering patients to make decisions in cooperation with their doctors and the developers of potentially life-saving therapies. This law intends to diminish the FDA’s power over people’s lives, not increase it.”

The bill, which President Donald Trump signed into law Wednesday, allows terminally ill patients to obtain unapproved drugs that have passed initial safety testing in Phase I clinical trials directly from drugmakers, but without the FDA’s oversight. H.R. 5247 – dubbed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act – passed in the House of Representatives last week.

Proponents say the law is necessary to provide terminally ill patients quick access to experimental drugs they would be otherwise unable to receive due to ineligibility for clinical trials and a purported slowness in the FDA’s Expanded Access program. But critics of the law note that the FDA approves nearly all requests made under Expanded Access, while the application process has been greatly streamlined, with the application now taking less than an hour to complete.

Critics have also pointed out that right-to-try does not include the Expanded Access program’s patient-safety measures, such as institutional review board oversight and mandatory reporting requirements. Moreover, drug companies have no obligation to honor right-to-try requests, and major drug companies like Merck & Co. and Johnson & Johnson’s Janssen subsidiary have taken a negative view of the law.

An earlier version of the bill passed in the House in March. That included more safeguards, such as greater FDA oversight, stronger reporting requirements and a narrower definition of who is eligible to receive drugs under right-to-try. However, the version that became law was stripped of those provisions.

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