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Regulatory News | 11 January 2018 | By Michael Mezher
In a perspective published in the New England Journal of Medicine on Wednesday, bioethicists Holly Fernandez Lynch and Steven Joffe of the University of Pennsylvania warn that federal "right-to-try" legislation could undermine the US Food and Drug Administration's (FDA) public health mission and will have a limited impact on improving patient access to investigational products.
The debate around right-to-try centers around patients' ability to access unapproved drugs to treat serious or life-threatening diseases outside of a clinical trial. While proponents of right-to-try argue that FDA is a barrier to patient access, FDA and critics of right-to-try laws have countered that the agency approves nearly all of the thousands of expanded access requests it receives each year.
So far, 38 states have passed right-to-try laws, and in August 2017, the US Senate passed a bill known as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, which seeks to bring right-to-try to the federal level.
The House is currently working on its own right-to-try bill, sponsored by Rep. Andy Biggs (R-AZ), which Politicoreports Vice President Mike Pence is pushing to see passed.
Lynch and Joffe say federal right-to-try legislation will "sharply curtail the FDA's oversight," though they also argue that the legislation's actual impact would likely be limited as it would not compel drugmakers to provide greater access to unapproved products.
Speaking to Focus, Lynch said she believes the legislation could give patients false hope "that they've been given a federal right-to-try experimental medicines and then companies still refuse to provide access."
Lynch also said she doesn't believe drugmakers are necessarily unjustified in refusing expanded access requests, as their focus is on getting their product to market for the broader patient population. For smaller companies, dedicating staff and resources to patients outside of a clinical trial is often unfeasible.
But in the public debate over right-to-try, Lynch said the pharmaceutical industry has been "remarkably quiet."
"It's a shame because I think what's happened is that we have this whole debate about FDA, and whether FDA is getting in the way, but actually FDA is not getting in the way, they approve the vast majority of these requests," she said.
Lynch and Joffe acknowledge that there are barriers to accessing unapproved treatments, but contend that the ones addressed by right-to-try laws are not the ones that are "rate-limiting" to patients, and that some of those "barriers" provide tangible safety benefits.
In its expanded access program, FDA often recommends changes to the proposed treatment protocol based on safety information that would be unavailable to the requesting physician at the time.
"Proponents of right-to-try are really focused on patient autonomy, and in order to promote autonomy you need to have adequate information, and I think that's something that's going to be lacking in the right-to-try context," Lynch said.
Tags: Right-to-Try, Expanded Access