“Right to Try” Does Not Help Patients

Co-Blogged by Christopher Robertson and Kelly McBride Folkers (research associate at the Division of Medical Ethics of the NYU School of Medicine)

In 2014, Arizonans overwhelmingly voted in favor of a ballot referendum that claimed to allow terminally ill patients the “right to try” experimental drugs that have not yet been approved by the Food and Drug Administration (FDA). Despite the policy’s broad support, it has yet to help a single patient in Arizona obtain an experimental drug that they couldn’t have gotten before. Thirty-seven other states have also passed right to try bills, but likewise have seen little real impact for patients.

“Right to try” has moved to the federal stage, as the U.S. Senate unanimously passed such a bill last August without even holding a hearing. The House Energy & Commerce Subcommittee on Health considered the bill in an October hearing, but it failed to garner much enthusiasm among committee members. Vice President Mike Pence has advocated for a federal right to try law, and he recently met with FDA Commissioner Scott Gottlieb and House leadership to encourage pass of the bill this year.

A new ad campaign in the D.C. area, funded by several special interest groups backed by Charles and David Koch, asks Congress to pass “right to try.”  The ad begins by asking, “What if we told you right now, in America, thousands of patients can’t access potentially life-saving treatments?”  Since 1987, thousands of patients and their physicians have been asking drug companies for use of their experimental drugs through a system called “expanded access.” When drug companies have agreed to provide experimental products to patients, they then apply to the FDA. The new bill frames the FDA as if it were the main barrier to accessing experimental drugs. In reality, the agency allows over 99 percent of the requests it receives to proceed, and it typically responds in days or even hours when needed.

Although the FDA hardly ever refuses a request, it does sometimes inform the doctor of better alternatives or suggest revisions in dosage, which ultimately improve a patient’s odds. After all, treating physicians are rarely experts on new products that have not yet reached the market. The new legislation seeks to eliminate FDA oversight, but doing so puts patients at greater risk of real harms.

The new law allows drug companies to charge patients for use of their investigational products, but provides no funding mechanism. It includes no requirement for insurers to pay for the products, which are typically excluded from coverage as “experimental.” Only patients who are able to pay for use of experimental drugs would be able to exercise their “right to try.” A better approach would focus on improving access in situations where a drug-in-development may be helpful.

Finally, the new law would make it impossible for injured patients to hold their doctors or drug companies accountable, even when they behave unreasonably or have deep conflicts of interest. These sorts of liability waivers are golden for lobbyists and the well-heeled special interest groups the billionaire Koch brothers support, but they undermine the basic protections that all patients deserve. It is not too much to expect independent and reasonable advice from your own physician.

All Americans want patients to have access to the lifesaving drugs they need, but there is no need to undermine the FDA’s expert role, which ensures quality science to prove safety and efficacy.  There are, however, opportunities to create incentives and reimbursements that may help patients access promising drugs in the development pipeline.

 

This entry was posted in Christopher Robertson, FDA, Health Law Policy, Liability, Pharmaceuticals, Scientific Evidence by crobertson. Bookmark the permalink.

About crobertson

Christopher Robertson is a professor at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute. Professor Robertson's research focuses on how the law can improve decisions by individuals and institutions -- attending to informational limits, conflicting interests, and cognitive biases, especially in the domain of healthcare. Blending legal, philosophical, and empirical methods, Robertson's work has been published in the New England Journal of Medicine, New York University Law Review, Cornell Law Review, Emory Law Journal, and the Journal of Empirical Legal Studies. He has received research support from the Robert Wood Johnson Foundation, and runs the Law and Behavior Research Lab at the University of Arizona. Robertson graduated magna cum laude from Harvard Law School, where he also served as a Petrie Flom fellow and lecturer. He earned a doctorate in Philosophy at Washington University in St. Louis, where he also taught bioethics. For 2013-2014, he was a visiting professor at Harvard Law School, and will visit at NYU School of Law in 2016-2017. Robertson's legal practice has focused on complex litigation involving medical and scientific disputes.