WASHINGTON — With President Trump’s signature, a measure offering terminally ill patients expanded access to unapproved treatments became the law of the land on Wednesday, ending a protracted legislative debate over whether it would help eliminate bureaucratic hurdles or simply offer the desperate a sense of false hope.
Surrounded by patients with life-threatening illnesses and their families, Trump used the 30-minute signing ceremony to make lofty promises about how “tremendous” the new law would be. He promised it would help scores of people get faster “access to experimental treatments that could improve or even cure their conditions.”
“We will be saving — I don’t even want to say thousands because I think it’s going to be much more — thousands and thousands, hundreds of thousands, we’re going to be saving tremendous numbers of lives,” Trump said. “There were no options, and now you have hope.”
He reveled in the accomplishment, a rare delivery of one of the many health care promises he made on the campaign trail. He also spoke off the cuff about how much he loved the bill’s name, “right to try,” and gave repeated hugs to 9-year-old Jordan McLinn, an Indiana native with muscular dystrophy who has been an advocate of the law for years.
More than 100 others, including Vice President Mike Pence, Health and Human Services Secretary Alex Azar, Food and Drug Administration Commissioner Scott Gottlieb, and federal and state lawmakers who supported the bill, like Sens. Ron Johnson (R-Wis.) and Joe Donnelly (D-Ind.) and Reps. Michael Burgess (R-Texas) and Brian Fitpatrick (R-Pa.), joined Trump a the basement auditorium in the Eisenhower Executive Office Building for the ceremony.
Opponents of the law say Trump’s promises to help thousands or even hundreds of thousands are grossly unrealistic. It isn’t clear that any patients have successfully utilized the dozens of state laws that attempt to give patients a similar pathway for expanded treatments.
The pomp and celebration of Wednesday’s signing ceremony — with its half-dozen standing ovations for Trump, Pence, and the families present — stands in contrast to the tumultuous, years-long journey the bill took to get to the White House. The legislation’s earliest champion, Johnson, has been pushing for its passage since his 2016 Senate campaign. He ultimately achieved his priority by threatening to derail a separate bipartisan law that renewed expiring funding for thousands of jobs at FDA.
The legislation languished until January, when Trump called for its passage in his State of the Union address. He and Pence, a longtime supporter of the movement, have been persistent advocates for quick action. Though key House Republicans and Gottlieb repeatedly and even recently expressed concerns with that legislation and worked to release an updated draft, the House eventually passed the Johnson bill when it became clear the new version would not make it through the Senate quickly.
Supporters say the new law gives dying patients an important reprieve from overly cumbersome FDA rules, and from what they call a slow-moving bureaucracy that can delay access to time-sensitive treatments.
Opponents have cautioned that the legislation will undermine FDA’s authority and open vulnerable, desperate patients up to “snake oil salesmen.” They point out, too, that the FDA already has a process in place for approving such requests and grants some 99 percent of them, often within a short time frame.
It is the FDA that will have to take the next steps to implement the legislation — and Trump on Wednesday didn’t miss the chance to press Gottlieb to move quickly.
“Scott, can you start immediately? We don’t want to start tomorrow,” he said to the FDA commissioner. “What time is it now? How about in 15 minutes?”
In a statement, Gottlieb said the agency stands ready to implement the new law “in a way that seeks to protect [patients’] autonomy, their safety, and the safety of others following in their paths.”
“We recognize the important balance between making sure patients have the assurances Congress intends, while enabling timely access to promising treatments in these devastating circumstances. And we’ll implement this new law consistent with these longstanding values,” he said.