Editor’s Note: U.S. Sen. Ron Johnson (R-WI) has introduced the Trickett Wendler Right to Try Act of 2017. The bill would ensure the effectiveness of state right-to-try laws, which aim to expand treatment options for terminally ill patients. Right-to-try laws have passed in 33 states since May 2014, most recently in Ohio in January 2017.
The combination of national and state right-to-try legislation would protect from recrimination terminally ill patients, along with their physicians and manufacturers of drugs and medical devices, who try to extend and improve their lives using experimental treatments only partially approved by the U.S. Food and Drug Administration (FDA).
Hamilton: How does Republican control of the White House and Congress improve the prospect of passing national right-to-try legislation in 2017?
Sen. Johnson: This really is a bipartisan issue. Two-thirds of the states have adopted right-to-try laws, and several more may pass laws this year. So far, over 4,000 legislators have voted in favor of right-to-try legislation. That’s about 97 percent of all the legislators of all parties who have had a chance to vote on such laws. The current version of my bill has 44 cosponsors in the Senate, and Vice President [Mike] Pence supported and signed a state right-to-try law while he was governor of Indiana. He has also committed publicly that he and the president are behind right-to-try.
Hamilton: How would state and national right-to-try laws expand treatment access for terminally ill patients, compared to FDA’s existing Compassionate Use program?
Johnson: This would not affect the Compassionate Use program. The Trickett Wendler Right to Try Act would provide more options to terminally ill patients who have no other alternatives. It expands the protections to patients, doctors, and companies, which will encourage more participation. Ultimately, it empowers terminally ill patients to make decisions for themselves.
Hamilton: Why is a national right-to-try law necessary to ensure state right-to-try laws protect patients, doctors, and treatment developers?
Johnson: Individual states still have to make their own decisions about whether to adopt a state right-to-try law. This bill says that if a state adopts such a law, the federal government will not stand in its way. State regulation of medical products is preempted by federal law. My bill would change that for patients who have no alternative but are informed of the risks and are willing to try experimental treatments.
Hamilton: President Donald Trump announced his intention on March 10 to nominate Dr. Scott Gottlieb as FDA commissioner. Is this a good sign for advocates of right-to-try?
Johnson: I have been a fan of Dr. Gottlieb’s writing and views. He will be a breath of fresh air at the FDA, who will advocate for greater patient choice instead of more government control.
Hamilton: Dr. Henry Miller, former director of the FDA’s Office of Biotechnology, wrote in The Wall Street Journal in March that your proposal “would enable patients to request the drugs after only the most meager safety testing.” Is a drug’s passage of Phase I testing an adequate measure of whether patients should be allowed to try it?
Johnson: Any drug administered under right-to-try has to not only complete Phase I testing but also be continuing on in the approval process. That is, it is a drug the sponsors believe shows promise and is likely to be approved eventually. The real litmus test is whether a patient facing a significant mortality risk and no alternatives, together with his or her physician and the [drug] company, believe there is a reasonable chance of improvement based on available evidence.
Hamilton: After passing right-to-try laws to help terminally ill patients, what additional reforms should Congress and FDA adopt to expand experimental treatment options for non-terminally ill patients?
Johnson: The ultimate answer comes down to reducing the cost of developing and approving successful treatments. The average cost to bring to market a new prescription drug is more than $2.5 billion, a number that continues to increase. With advances in computing and other technology, this number should be going down, not up. Advances in personalized medicine could mean incredible benefits for all patients, but we’ll need an FDA that doesn’t cling to old models of how to evaluate effectiveness, and we in Congress need to be more flexible toward patients looking for hope.
Michael T. Hamilton ([email protected], @MikeFreeMarket) is a Heartland Institute research fellow and managing editor of Health Care News, author of the weekly Consumer Power Report, and host of the Health Care News Podcast.
Senate Bill 204: Trickett Wendler Right to Try Act of 2017: https://www.heartland.org/publications-resources/publications/s-204-trickett-wendler-right-to-try-act-of-2017
Michael T. Hamilton, “Unalienable ‘Right to Try’ Deserves Protection by Feds and All 50 States,” Townhall.com, July 4, 2016: https://townhall.com/columnists/michaelhamilton/2016/07/04/unalienable-right-to-try-deserves-protection-by-feds-and-all-50-states-n2186275
Sean Parnell, “Lindsay Boyd: Right to Try,” Health Care News Podcast, The Heartland Institute, January 23, 2015: https://www.heartland.org/multimedia/podcasts/lindsay-boyd-right-to-try
Gregory Conko and Bartley J. Madden, Free to Choose Medicine, The Federalist Society, October 1, 2013: https://www.heartland.org/publications-resources/publications/free-to-choose-medicine
Sen. Ron Johnson (R-WI): https://www.ronjohnson.senate.gov
Dr. Scott Gottlieb, presumptive nominee for FDA commissioner: http://www.aei.org/scholar/scott-gottlieb/
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