W

ASHINGTON — 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.”

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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.

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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.

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  • Wow – the snide sneering tone of your article is so disappointing… Trump made “lofty” promises about how “tremendous” the new law would be”… but I am not surprised. The media can’t be trusted to provide impartial reporting on anything President Trump does. Don’t you understand that all you are doing is alienating your readers and making them feel animosity towards you and your publication when you write like this. We will always side with Trump over the leftwing elitist because we understand he is trying to put Average Americans first, and in this particular case – he’s simply signing into law something that is aimed at helping those that are in desperate need life saving medical treatment – many of which have already expended all other options. How irresponsible of Erin Mershon for writing like this, and for statnews for printing it.

    • They are incapable of hiding the hate. Also, they hope the tone of the story will influence their readers. This is activism. the pen is their sword

    • You are being perhaps a bit harsh? Very few health and drug reporters have the technical background and experience to meaningful value judgments about the pronouncements of regulators or producers. And bad news on health dont sell ads . . .

    • The article summarizes the history of the bill, the arguments of proponents and opponents, describes which politicians (D or R) have been prime supporters, and describes the president’s degree of involvement. It focuses on the latest news, the signing. Here’s a direct quote, allowing the president to speak for himself:

      “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.”

      And your takeaway is that the author must be some kind of leftwing elitist to include in their description of the signing such things as:

      “Trump made “lofty” promises about how “tremendous” the new law would be”

      Wow, how terribly that misrepresents the president (see the quote). You must feel very oppressed to be faces with such extreme partisanship and hostility. Do you need your safe zone? It seems there are snowflakes on both sides of the political spectrum. (And yes, I criticize left wing snowflakes as well; my own advocacy is more about rational vs irrational than left vs right. I would be and have been just as critical of similar hypersensitivity from a left leaning “snowflake”)

      And you proudly tell us that you will always side with Trump in these cases. But you think that the author is the one introducing strong political partisanship into the narrative.

      What I find on both left and right extremes is that anything balanced or moderate, acknowledging both pro and con viewpoints, is perceived as slanted towards the opposite because it’s not sufficiently biased towards their side and dares to suggest that there can be more than one side to an issue. This is heresy to anyone certain that their own position is completely right and no deviation from their party line should be tolerated. Sadly, we can find too many such extremists on both sides, poisoning our politics into polarized gridlock.

  • Enough with the nasty commentary. How about just reporting it and let people get their own opinion.

  • A “snake-oil” piece of legislation signed by none other, Snake-oil in chief, con man. Perfect.
    Won’t do anything other than give false hope, at best, and at worst, encourage terrible science. Well done.

    • How on Earth do you know what this will or “won’t” do? What a joke your comment is. If this saves ONE life, it’s worth it.

  • Interesting subject, but the absurd comments about the president killed it, and I stopped reading. Report and let the people decide for themselves. That used to be journalism. We don’t want you to “teach ” us. We just want to read your darn article without being preached to.

  • The author seems almost comically unprofessional and self-indulgent here in making multiple off-point random digs at Trump when the story is about a broadly popular measure with a lot of bipartisan support designed to help the terminally ill. I don’t happen to like Trump myself but he is not a major part of this story and the writer’s hostility to the president should not be front and center in a piece like this. Sheesh.

    • To the contrary, President Trump had been actively involved in the campaign to pass this legislation, notwithstanding hesitation among lawmakers, republican and democrat alike. And Erin is hardly off-point to accurately commentate that this legislation becoming law is, “…a rare delivery of one of the many health care promises he made on the campaign trail.”

    • Yes, Nicholas, Erin accurately pointed out that one fact. Apparently you missed all the parts that were condescending and dripping with insult. As someone else stated, the media doesn’t even TRY to hide it’s bias against and hatred of the President. And no, I didn’t vote for Trump.

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