Right-to-try is designed to weaken the FDA, law’s author says

Perceived problems with the new right-to-try law are features, not failings, according to the senator who authored the bill. (Sen. Ron Johnson)

The author of right-to-try legislation is pressuring Scott Gottlieb, M.D., to implement the law in a way that weakens the FDA. 

Writing to Gottlieb following the signing of the legislation by President Trump, Sen. Ron Johnson, R-Wisc., gave a blunt assessment of what he wants the law he authored to achieve. 

“This law intends to diminish the FDA’s power over people’s lives, not increase it,” Johnson wrote in a letter (PDF) to Gottlieb.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

Johnson applied the pressure after reading comments from Gottlieb suggesting the FDA may need to create guidelines and regulations to protect patients.

Talking to STAT last month, Gottlieb noted ways in which the patient protections baked into the law fall short of what the FDA would like to see. Gottlieb suggested the FDA could iron out the perceived shortcomings of the law with guidance and regulations, resulting in an approach that balances access to experimental drugs against patient protections while meeting the goals of legislators. 

But to Johnson the perceived problems with the law are features, not failings. The senator wants the legislation to limit the FDA’s ability to try to protect patients—and will kick up a stink if Gottlieb tries to mitigate its effect on the agency. 

“It is designed to work within existing FDA regulations, definitions and approval processes. It is not meant to grant the FDA more power or enable the FDA to write new guidance, rules or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments,” Johnson wrote.

Johnson went on to explain the intent of key features of the legislation, including the breadth of diseases to which it applies and the limitations it places on the FDA’s ability to use data generated in right-to-try contexts in regulatory decisions. The senator wants to meet with Gottlieb to further explain the intent of the law and ensure the FDA’s implementation is consistent with this thinking.

The comments support suspicions that the law is intended to weaken the FDA. Johnson and other advocates of the legislation argued it will give hope and treatment options to patients with terminal illnesses. But their opponents saw the law as undermining the FDA and traditional drug development by encouraging patients to access experimental therapies outside of closely-monitored clinical trials.

Suggested Articles

Sumitovant CEO Myrtle Potter discusses the $3 billion Roivant-Sumitomo deal, her role at Sumitovant and what's up in 2020.

Antibiotics player Summit Therapeutics is gearing up for a new clinical trial of its lead asset, an antibiotic for Clostridium difficile infection.

In this week's EuroBiotech Report, Roche's risdiplam clears another phase 3 SMA trial, Merck KGaA spinout raises cash and Korean VCs back PDC*line.