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What you need to know about the Senate’s “right-to-try” bill

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The Senate passed a health care bill today with 94 votes. It turns out funding the FDA is way more popular than repealing Obamacare.

The Senate also approved another bill alongside the FDA funding: Sen. Ron Johnson's "right-to-try" legislation.

You might have heard of the "right-to-try" movement. The gist of it is: Terminally ill patients should be given wide latitude to try out unproven treatments if they have exhausted all their other options.

More than 30 states have passed a "right-to-try" bill, often favored by more libertarian-minded people, and now the Senate has too. Supporters portray it as a humanitarian exercise for people with no other hope that removes the risk of a bureaucracy getting in their way.

But skeptics have two big objections: first, that these bills are unnecessary because the FDA already does a good job letting terminally ill people access experimental treatments. And second, that the only thing these bills do achieve is open up patients to more risk.

Alison Bateman-House, who studies medical ethics at the New York University Langone Medical Center, walked me through the complexities.

"We have a functioning expanded access procedure through the FDA," she told me.

It might help to understand how the FDA's current program works and what it would look like under "right-to-try."

Under the FDA's current policy, patients who want to try a treatment that has cleared only the first round of clinical trials must:

  1. Find a doctor who will agree to try the therapy.
  2. Contact the drug company to ask permission to test the treatment.
  3. With that permission, fill out paperwork for the FDA and send it in.
  4. If the FDA doesn't object, the patient can try the treatment.
  5. A board at the institution where the treatment is taking place must also be notified and grant approval.
  6. The patient must grant consent and may have to pay money for the treatment.

Under the "right-to-try" bill, the process is almost exactly the same, except the FDA is removed from the equation:

  1. Find a doctor who will agree to try the therapy.
  2. Contact the drug company to ask permission to test the treatment.
  3. With that permission, the patient can try the treatment.
  4. A board at the institution where the treatment is taking place must also be notified and grant approval.
  5. The patient must grant consent and may have to pay money for the treatment.

(Please note that pharmaceutical policy is hopelessly complex, so these are the broad strokes. Also, state laws differ, so how they would interact with any new federal law could differ as well.)

A couple of things are important to note. First, based on the available data, the FDA already approves 90 percent or more of the requests it receives to try unproven therapies, and the agency usually responds in a matter of days, Bateman-House told me.

So there isn't much evidence of a pandemic of terminally ill patients being blocked from testing treatments because of bureaucratic snags.

Second, in both cases, the real hurdle is getting approval from the drug company to test a treatment. That would still be true under a "right-to-try" regime.

"You have a right to ask a drug company if you can try," Bateman-House said. "The only thing that disappears is that FDA step."

And therein lies the concern of Bateman-House and others. The existing program, which would still be in place even if "right-to-try" becomes law, allows the FDA to be an independent arbiter.

Without that federal oversight, Bateman-House believes there is a greater risk for fraud and abuse at the expense of patients.

"By getting rid of that, what you’re doing is you’re relying on a doctor and a quote-unquote drug company," she explained, "but there are no specifications about that relationship."

"For all I know, the doctor works for the drug company, owns the drug company, owns stock in the drug company, or the drug company gives the doctor kickbacks," she continued.

This is the bottom line, based on my conversation with Bateman-House:

  • The FDA already has a functioning procedure for experimental treatments.
  • The "right-to-try" bill actually leaves that procedure in place.
  • All the bill does is potentially create an alternative pathway for patients.
  • We don't even know if patients will take it.
  • If they do, because the FDA is no longer a part of the process, there is a greater risk for fraud and abuse.

"This area is already replete with confusion, and we don’t need any more confusion," Bateman-House told me. "I think patients are going to end up losing."

For more on the intricacies of "right-to-try" and the FDA funding bill, please read Sarah Karlin-Smith at Politico and my former colleagues at STAT.

Chart of the Day

health spending public/private/pocket The Nation

What makes American health insurance so unique. You should read this piece in the Nation, about the challenges of actually formulating and implementing single-payer health care, in its entirety. But this chart struck me. The point is: It's not so much that no other country has private health insurance or the United States doesn't have public insurance. It's that the United States is uniquely reliant on private coverage.

Kliff’s Notes

With research help from Caitlin Davis

Today's top news

  • “Molina Healthcare to exit ACA exchanges in Utah, Wisconsin”: “Molina Healthcare Inc. said Wednesday it will exit the Affordable Care Act’s insurance marketplaces in Utah and Wisconsin by the end of this year, citing costs that contributed to hefty losses for the health insurer in the second quarter.” —Alex Veiga, Associated Press
  • “Senate approves key FDA legislation, sending bill to Trump’s desk”: “The Senate on Thursday, without fanfare or controversy, approved legislation that will keep many Food and Drug Administration operations running and deliver a significant win to the pharmaceutical industry.” —Erin Mershon, STAT
  • “Trump rolls out new telehealth services for veterans”: “The Trump administration on Thursday announced a new effort to expand veterans' access to telehealth services around the country, which includes a new app that will let veterans make healthcare appointments from their cellphones.” —Pete Kasperowicz, Washington Examiner

Analysis and longer reads

  • “New bipartisan Obamacare push faces steep climb”: “Lamar Alexander (R-Tenn.), chairman of the Senate Committee on Health, Education, Labor and Pensions, and ranking Democrat Patty Murray of Washington are up against both time and history in their race to stabilize the shaky Obamacare markets and solidify their status as the chamber’s top deal-makers.” —Jennifer Haberkorn and Adam Cancryn, Politico
  • “Health Insurer Payments in Crosshairs”: “The health industry is heading into a pivotal few weeks that will determine whether the White House keeps making billions in payments to insurers or whether Congress will take over responsibility for them — decisions that rest on complex political calculations.” —Louise Radnofsky and Michelle Hackman, Wall Street Journal
  • “Professional Athletes And Back Surgery: A Teachable Moment On Overuse In Health Care?”: “Unnecessary expenditures for health care overuse in the United States are estimated to range from 10 percent to 30 percent of total health care spending or, at a minimum, $300 billion a year.”—William Shrank, Donna Keyser, and Anthony Delitto, Health Affairs

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