Right-to-Try advocates in Congress mislead the public for political gain

This past May, in the midst of a grueling race to retain his Senate seat, Wisconsin Sen. Ron Johnson introduced the Trickett Wendler Right to Try Act of 2016. Now, trailing against former Sen. Russ Feingold, according to the most recent RealClearPolitics polling average, Johnson is publicly advocating on behalf of this politically attractive and emotionally stirring bill. In a recent issue of the Wall Street Journal, Johnson argued that Right to Try, aimed at helping terminally ill patients obtain experimental drugs that have not received approval from the Food and Drug Administration (FDA), would “give patients and families the freedom to decide for themselves how to fight their illness.” At a hearing he contended that “for the millions of patients fighting for a chance to try, we must do what we can to help them.” And while he recognized that “Right to Try is not a cure,” he claimed nonetheless “it is a way to hold on to hope.” But, given the state of his Senate race, it is worth asking whether this bill is more of a political corrective for Johnson than a policy fix for patients understandably eager to try anything that could help.

While Johnson contends this legislation would provide terminally ill patients with the right to try unapproved drugs, it would actually do no such thing. Like similar right-to-try laws that have passed in more than 30 states, Right to Try attempts to circumvent the FDA approval process by ostensibly permitting drug companies to provide unapproved drugs to terminally ill patients without first obtaining FDA permission through what is known as “expanded access” or “compassionate use.”

{mosads}But here is the rub: Right to Try does little to help terminally ill patients access experimental therapies. The FDA already has a procedure for permitting access, and it approves 99 percent of these “expanded access” petitions, a point emphasized again by the FDA at the recent hearing. Despite this fact, right-to-try advocates maintain that the FDA remains a roadblock to access. But even if FDA approval is not required, Right to Try does not obligate insurance companies to cover the cost of providing these drugs and does nothing to require or even encourage pharmaceutical companies to offer them.

As a result, if this bill became law, patients would not have a right to try experimental drugs because pharmaceutical companies would have no obligation to provide them. It might make it marginally easier for patients to petition private pharmaceutical companies to provide such drugs, by obviating the need to first appeal to the FDA, but these companies have ample reason to deny such requests. Many companies, especially smaller ones with fewer financial resources, have limited supplies, so honoring the petitions of patients could delay clinical trials and cause future patients – who might benefit if the drug were approved for market – to suffer. Moreover, the company would have to wait longer to see any return on its investment.

To be sure, Right to Try attempts to incentivize drug companies to provide experimental therapies by insulating companies from liability for any adverse effects patients experience and prohibiting the FDA from counting these events against the drug in the approval process. Yet the resource problem still remains, and asking the FDA to ignore adverse events as it evaluates whether a drug is safe and effective is negligent at best. Indeed, as FDA official Peter Lurie noted during the hearing, “Given that the Agency is charged with assessing the safety and effectiveness of medical products, the Agency cannot ignore valid scientific information.”

If Right to Try does little for patients, it certainly helps those politicians promoting it. That is because right-to-try legislation is incredibly popular. When similar legislation was on the ballot in Arizona, it passed with nearly 80 percent support. As Sen. Johnson rightly asserted, “right-to-try laws are passing with nearly unanimous support” across the country.

Instead of misleading patients for political gain, Sen. Johnson and other right-to-try advocates should focus on helping companies provide these drugs free of charge to patients in need in an equitable way. Just over one year ago, Johnson & Johnson began a pilot program in partnership with the NYU School of Medicine to establish an independent group known as the Compassionate Use Advisory Committee, or CompAC, to help them fairly evaluate patient requests. Instead of uselessly demonizing the FDA right-to-try advocates should encourage other pharmaceutical companies to follow Johnson & Johnson’s lead.

Sen. Johnson is right: Patients suffering from terminal illnesses deserve hope, wherever it can be found. But if that is the goal, then Congress should focus on policies that will actually help these people instead of pursuing legislation that merely pads their poll numbers.

Aaron C. Shapiro is a 2016 graduate of Harvard Law School. Follow him at @acshapiro.

The views expressed by authors are their own and not the views of The Hill.