A so-called ‘Right to Try’ bill is making its way to Alaska. Right to Try claims to provide dying patients with quick access to experimental drugs not yet approved by the Food and Drug Administration (FDA). Yet, in reality, Right to Try will do more harm to patients than good. Right to Try — introduced in both Alaska’s House and Senate by Rep. Jason Green and Sen. Bill Wielechowski, respectively — will do little to change the situation for terminal patients. Rather, we — two patient advocates and an academic — firmly believe these bills will not aid the patients it purports to help. We urge Alaskans to oppose these proposed bills, in order to help protect vulnerable patients.
On the surface, the Right to Try appears beneficial: dying patients, who have no treatment options left, will be able to access experimental drugs that may help extend their lives. The bill is little more than an empty promise, claiming patients have a right to experimental medications while holding no one accountable for upholding this right: not doctors, not drug companies, not insurers.
Not only is Right to Try an empty gesture, but it detracts from real ways to help these patients. Patients already have the right to request access to experimental medications via the FDA’s Expanded Access Program — and they have had this option since 1987. Under federal law, patients with no treatment options can petition a drug manufacturer for ‘compassionate use’ of an experimental medication.
Right to Try advocates claim this pathway is too slow, placing the blame largely on the FDA, which must approve all applications for experimental drugs for American patients. Yet, the FDA approves these requests over 99 percent of the time, and does so within days. In emergency cases, the FDA can give patients an answer within hours.
At a time when access to health care is in a precarious state for many Americans, Right to Try is fatally flawed. The law will offer patients a right to ask, or more pointedly, beg, for medication — while offering no means of producing anything tangible from that ask. Rather than help patients, this legislation seeks to scapegoat a government agency that is not the problem. The FDA has actually taken steps to streamline the process for compassionate use requests, implementing a “concierge service” to help patients and their doctors with the process and decreasing the amount of time needed to fill out paperwork for a request.
Under both Right to Try and current compassionate use policies, patients must request the drug from the manufacturer, which is where the true obstacle lies. Pharmaceutical companies are under no obligation to make their investigational drugs available to patients. Right to Try does nothing to remove this obstacle, the same barrier to access that patients already face.
To help patients, we must remember the pharmaceutical company making the new drug ultimately determines who, if anyone, gets it outside of a clinical trial. To receive access to a new drug for compassionate use means reaching out to the pharmaceutical company. These companies perform dismally in making their compassionate use policies known to both patients and physicians. According to a recent report, only 19 percent have publicly published their policies on compassionate use. Not knowing how to request access is a significant barrier for patients seeking quick access to experimental treatments. The 21st Century Cures Act, passed last December with wide bipartisan support, aims to fix this problem by mandating pharmaceutical companies to make their compassionate use policies publicly available.
Alaska’s State Senate and House need to vote no to the Right to Try bills. In justifying their rejection, senators should explain that legislative energy could — and should — be focused on encouraging transparency on the part of pharmaceutical companies when it comes to their compassionate use policies, rather than on passing an irremediably flawed Right to Try law.
As members of both the patient advocate and academic communities, we agree that Right to Try laws can’t and won’t help our loved ones, some of whom are fighting for their lives. The question remains: will legislators settle for an appealing sounding bill that isn’t worth the paper on which it’s printed — or choose to see past its rhetoric to focus on real change?
• Andrew McFadyen is the executive director of The Isaac Foundation and a member of the NYU School of Medicine’s Working Group on Compassionate Use and Pre-Approval Access. Alexandra Hall is the Managing Director and Policy, Patient Support and Industry Liaison of The Isaac Foundation. Kelly McBride Folkers is a research associate at the Division of Medical Ethics at the NYU School of Medicine.
