White House Backs “Right To Try” Law for Terminally Ill Patients
Rules related to access to experimental treatments would be relaxed
The White House is giving a big boost to proponents of a federal Right to Try law that they contend would give terminally ill patients easier access to medicines that haven’t won approval from the Food and Drug Administration.
Some supporters of the bill met Tuesday with Vice President Mike Pence, and last week they won a supportive statement from President Donald Trump, who has been contending that too many FDA rules in general pose unnecessary hurdles to drug approval. FDA data show that almost all terminal patients who seek access to drugs do receive them, but backers of the proposed law say there are too many hurdles to experimental treatments.
For more than two decades, the FDA has had a “compassionate use” program available for people with terminal illnesses. Peter Lurie, an FDA associate commissioner, testified last fall before a Senate committee that the FDA had authorized more than 99% of requests for access to drugs between 2010 and 2015. In fiscal year 2015, the agency got more than 1,200 such requestsand approved all but 10 of them, FDA statistics show.
The Goldwater Institute, a conservative think tank urging such legislation, said the FDA’s data show there are many people who have found the process of seeking unapproved drugs too daunting. “There is no possible way that only [about] 1,000 people per year want to try to save their own lives,” a spokeswoman said. “We just fundamentally do not believe that you should have to apply to the government for permission to try to save your own life.”
Rep. Andy Biggs (R., Ariz.), a sponsor of the legislation in the House, said the FDA’s compassionate-use program “is overly complicated, bureaucratic and takes too long for approval.”
Sen. Ron Johnson (R., Wis.) is a sponsor of the bill in the Senate, and his office said there now are 42 co-sponsors.
Such a law, if it passed, is among many measures Mr. Trump is urging to dispense with FDA rules that he says get in the way of innovation. “We’re going to be changing a lot of the rules” at the FDA, he said last week, adding that he plans to do away with about 80% of them. But consumer advocates contend most of those rules are essential to keep drugs safe.
Mr. Trump hasn’t yet named a new FDA commissioner.
A terminally ill patient, Matthew Bellina, testified before the same Senate panel last fall that proponents of the law don’t want to “undermine the FDA or relax the standards that must be met” for drug approval. “We simply believe that we can do better at getting promising treatments to sick and dying Americans,” he testified.
The FDA came under severe criticism three decades ago from AIDS patients who said dying people at least should get a chance to try experimental medicines. The agency has greatly expanded such access since then, broadening approval standards in cases like oncology drugs for patients who wouldn’t otherwise live.
Write to Thomas M. Burton at firstname.lastname@example.org