Close up view of the intricate detail of the U.S. Capitol Rotunda ceiling and silhouette of George Washington.
The Senate approved a bill supporting Right to Try in an effort to increase access to experimental drugs not yet approved by the U.S. Food and Drug Administration. It was part of the process of approving the FDA User Fee Reauthorization bill. Critics of Right to Try have raised concerns about the legislation, which has been passed in various forms in 37 states across the U.S.
For one thing, they point to the fact that the FDA already has a program in place to dispense medications to patients when physicians apply for them on their patients’ behalf. In a debate at the MedCity CONVERGE conference in Philadelphia this week on “Right to Try: Foolhardy or Compassionate?” Beth Roxland, Senior Consultant on Law, Ethics and Policy; Associate, Division of Medical Ethics, NYU Langone Medical School, argued the former. She pointed out that 99 percent of applicants for compassionate use, also referred to as expanded access, are given access to the medications they seek through the FDA’s Compassionate Use program. The turnaround time tends to be 24 hours.
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“I would encourage everyone to go to FDA.gov’s website and not to confuse the timeline it takes to get a drug approved [compared with] the amount of time it takes to get expanded access,” Roxland said.
Roxland also argued that Right to Try laws don’t mean the applicant automatically gets whatever experimental drug they think will save their life. It’s up to the companies to decide which patients get their drugs.
Arguing in support of the Right to Try bill, Christina Sandefur, Executive Vice President with the Goldwater Institute, said Right to Try was about keeping the government out of a decision best left to doctors and patients, although she conveniently left out the big pharma companies who also get to decide.
“The right to make your own decisions is the cornerstone of a free system,” Sandefur said.
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One notable part of the Senate bill is that manufacturers, distributors, prescribers, dispensers, possessors, have no liability regarding the treatment. So patients pay for these experimental drugs on their own, since payers would not be inclined to cover them. And if any terrible side effects happen as a result of taking that experimental medication, patients are on their own. It’s as libertarian as it gets.
The bill includes modifications from a previous version such as requiring the FDA to receive reports of adverse events arising from drugs accessed through the right to try legislation. That information can be reviewed by the FDA as part of the regulator’s decision whether or not to approve a new treatment.
It also prevents patients from being charged more than the cost of production for the drugs, according to Politico. Unlike the House version of the bill, the Senate Right to Try legislation allows patients access to medications even if they are not terminally ill.
The vote on Right to Try was part of a negotiation between the Senate bill’s author Ron Johnson (R-Wisconsin) and Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tennessee) to avoid Johnson delaying a vote on the FDA User Fee Reauthorization bill.
Photo: dkfielding, Getty Images
