The House should read the fine print on ‘Right to Try’ bill

“Right to try” laws, on the books in 37 states, claim to make it easier for terminally ill patients to access experimental drugs before they’ve been approved by the FDA. Yet in the more than three years since the first law was enacted, no one seems to have obtained any drugs via these laws that they couldn’t have gotten through the existing FDA Expanded Access Program. The laws have been a disappointment.

Actually, they are much more than that: They are fraudulent. The Supreme Court decided long ago that patients have no “right” to try experimental drugs. Also, “right to try” proponents claim that the obstacle between patients and investigational therapies is the FDA; thus, the legislation aims to rein in the authority of the FDA to regulate drugs in development in an effort to ease patients’ quests for investigational treatments. But ample evidence — including a recent study by the Government Accountability Office — has shown that the FDA’s existing Expanded Access Program has been a great success over the last several decades. The truth is that when patients are denied access to experimental drugs, it is because the companies that make them have said no, not the FDA. Right to try consistently ignores this fact.

{mosads}Advocates of this deceptive legislation are now pushing for a federal “right to try” law. A bill, S. 204, is currently before the House Energy and Commerce Committee, of which Rep. Greg Walden (R-Ore.) is chairman. The Senate ended up unanimously consenting to its passage after Sen. Ron Johnson (R-Wis.), S. 204’s sponsor, threatened to block crucial FDA funding if a vote on the bill didn’t proceed. But make no mistake: The Senate vote was not a vote of confidence for right to try. Indeed, the Senate watered its version of the bill down so much that one lawyer referred to it as “a right to try bill in name only.”

It is now the House’s turn to consider this hollow legislation. We hope representatives will recognize that right to try strips away important safeguards in the name of “helping” patients. And we hope they understand that there already exists a successful program through which patients can access experimental drugs — one that isn’t chiefly an industry and insurer liability shield. There’s a reason why some of the country’s largest and most reputable physician and patient advocacy organizations oppose this bill, including the American Society of Clinical Oncology, the Cancer Action Network of the American Cancer Society, the National Organization for Rare Disorders, and Public Citizen. In addition to the problems outlined above, S. 204 stipulates that if a patient were to die or be seriously harmed while using a drug obtained via right to try, information about the incident could not be evaluated by the FDA except under certain, select conditions. The agency ultimately decides if drugs available under right to try should be approved for use in the U.S., so blinding reviewers to this information prevents them from making a fully informed decision about a product. All of us are or will be patients, and we all should be very concerned about this feature of right to try.

Supporters of right to try in the House should consider these patient-hostile provisions; instead they are resorting to dirty tricks again. They are pressuring Walden to use legislative maneuvers to skip hearings on the bill. Without hearings and debate, legislators would not be voting on the bill’s merits but on its marketing instead. House lawmakers should wonder: What don’t right to try advocates want them to see? They are no doubt afraid that right to try will be exposed for what it is: bad policy grounded in anti-regulatory ideology while wrapped in the mantle of compassion for the seriously ill and dying.

The “right to try” to save your own life sounds reasonable and right, but, as the saying goes, all that glimmers is not gold. This policy gives patients no new rights. It creates a confusing, alternate pathway alongside the FDA’s established program, and exposes patients to physical, emotional, and financial harm. There are ways to help patients access experimental drugs, but right to try is not one of them.  

Bateman-House is an assistant professor at NYU Langone Health’s Division of Medical Ethics. McBride Folkers is a research associate at the Division, and Kearns is a senior research associate at the Division.