Obamacare repeal might be stuck in limbo land, but conservative activists notched a smaller health-care victory yesterday as Congress passed and sent to President Trump’s desk a “right to try” bill making it easier for critically ill patients to access experimental medicines.
After months of political wrangling and partisan bickering, the House passed a version of the measure approved by the Senate. Approved by a 250-to-169 vote largely along party lines, the bill is designed to give patients an alternative way to obtain drugs not approved by the Food and Drug Administration. "Patients would be eligible for right-to-try if they had a 'life-threatening illness' and had exhausted all available treatment options," The Washington Post's Laurie McGinley reports. “The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.”
What’s ironic about the whole thing is that by refusing to support a narrower bill the House had passed, Democrats are sitting by and watching a broader version – which they could have previously objected to but didn’t — become law. These two bill versions were in play:
1. A limited bill from Rep. Greg Walden (R-Ore.), which would have permitted the process only for patients likely to die “within a matter of months” or who have a disease likely to lead to “severely premature death" along with giving the FDA more oversight.
2. The version the House passed yesterday, originally sponsored by Sen. Ron Johnson (R-Wis.), which contains a broader pathway for more patients to access medications before they’re fully approved, and didn’t get as much input from the FDA.
Nearly every House Republican — and a few dozen Democrats — voted to pass the Walden bill in March, only to see things subsequently stall. Top Senate Democrat Chuck Schumer blocked the Walden bill from coming to the floor, even though he hadn’t put up a fight when its more sweeping cousin, the Johnson bill, passed the Senate by unanimous consent last August. That's why the House passed the Johnson version yesterday, so it could bypass the Senate and send it straight to the White House for a final signature.
When I asked Schumer’s office about his after-the-fact opposition, a spokesman pointed to comments the minority leader made on the Senate floor in March.
“The key is we need to ensure there are safety mechanisms in place when we do this,” Schumer said. “A significant part of that is making sure the FDA is part of the process.”
So what does FDA Commissioner Scott Gottlieb — whose agency would be putting the whole thing in motion — think of “right to try”? He appears casually supportive.
In the past, Gottlieb has stressed the agency has a pathway through its “expanded access” program to let terminally ill patients try experimental drugs. Last fall, he told a House subcommittee that most of the treatments allowed via this program are ineffective.
Gottlieb appeared more favorable to “right to try” in a Stat News interview last week, indicating he would have preferred the Walden bill, but feels the FDA can also work within the Johnson bill to ensure patient safety.
“In terms of making sure that it balances [access to experimental drugs] against appropriate patient protections, I think the Walden bill gives us less work to do,” Gottlieb told Stat. “With the Johnson bill, we’d have to do a little bit more … in guidance and perhaps in regulation to achieve some of those goals, and I think those are the goals that Congress wants us to achieve.”
Gottlieb tweeted this yesterday:
When the House passes #RightToTry legislation I stand ready to implement it in a way that achieves Congress’ intent to promote access and protect patients; and build on #FDA’s longstanding commitment to these important goals #RTT— Scott Gottlieb, M.D. (@SGottliebFDA) May 22, 2018
And in February:
#RightToTry policies rooted in strong desire to help patients facing terminal illnesses access experimental therapies with hope these treatments will help. #FDA shares the administration’s goal to help patients facing terminal diagnosis access promising treatments in their fight— Scott Gottlieb, M.D. (@SGottliebFDA) February 11, 2018
So if you go with Gottlieb’s take, it’s probably fair to say the bill’s real-world impact will probably be more muted than either its proponents or critics charge.
Koch-land has been spending big on promoting “right to try” as the salvo for seriously ill Americans. Its flagship group, Americans for Prosperity, ran digital ads in January and last month launched a six-figure TV and digital campaign calling on Congress to pass the legislation. The bills have been hugely popular at the state level, with Nebraska this month becoming the 40th state to pass “right to try” into law.
It’s also a pet project for Vice President Pence, who has personally advocated on Capitol Hill. And President Trump has chimed in, calling for “right to try” in his State of the Union address and again when announcing his drug pricing initiative two weeks ago.
From Vice President Pence:
Great to welcome Jordan McLinn back to the @WhiteHouse today. We look forward to the House passing #RightToTry this afternoon to give seriously ill patients a fighting chance. This brave young man is an inspiration to me and many others. Way to go Jordan! pic.twitter.com/RVvSbrQ2RQ— Vice President Mike Pence (@VP) May 22, 2018
From Sen. Johnson:
From Rep. Marsha Blackburn (R-Tenn.):
Patients, parents & loved ones dealing with terminal illness deserve a #RightToTry. As a co-sponsor in the House, I’m thrilled to be voting for the Right To Try bill that gives Americans greater access to experimental medicines. Looking forward to @POTUS signing into law! pic.twitter.com/M4DIDeyDR8— Marsha Blackburn (@MarshaBlackburn) May 22, 2018
The fact that Trump and Pence got so involved may have soured Schumer and Democrats on “right to try,” advocates charge. “Schumer doesn’t want to give the president a win, that is what this is about,” Starlee Coleman, senior policy adviser to the Goldwater Institute, the legislation’s chief champion, told me. “It is totally political.”
As for outside opponents — which include patient groups and four former FDA commissioners — they’re even more upset Congress ultimately passed the more lenient Johnson bill than the narrower Walden bill. More than 100 advocacy groups sent a letter to House members yesterday, asking them to oppose “right to try” because it would “allow unproven therapies to be given to patients without FDA notification for up to a full year.”
“The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current expanded access process,” the American Cancer Society Cancer Action Network, the National Organization for Rare Disorders and other groups wrote.
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AHH: Late yesterday afternoon, the Department of Health and Human Services proposed an awaited rule change banning recipients of Title X family planning funds from providing abortions or referring for them. Just hours later, Trump touted the move at a gala hosted by leading antiabortion group Susan B. Anthony List and urged for further the movement's goals by electing more antiabortion Republicans in November. “Every day between now and November we must work together to elect more lawmakers who share our values...and proudly stand for life,” Trump said.
The president also criticized four moderate Democratic senators -- Jon Tester of Montana, Heidi Heitkamp of North Dakota, Claire McCaskill of Missouri and Debbie Stabenow of Michigan -- who voted against a 20-week abortion ban earlier this year. These senators voted "in favor of late-term abortion," the president said. "We are nine votes away from passing the 20-week abortion bill in the Senate. So we have to get them out of there."
OOF: The death rate for prostate cancer has stopped decreasing, after a two-decade decline, and new research has found increasing incidences of advanced stages of the disease. The trend coincides with a decline in screening for the disease, though it’s not clear if that caused the shift, our colleague Laurie McGinley reports.
The new research has reignited debate over screening for prostate cancer through prostate-specific antigen (PSA) tests. In 2012, a federal advisory committee discouraged routine use of PSA tests for all men, but this month, the U.S. Preventive Services Task Force took the position that screening provides a small benefit for some men ages 55 to 69.
“Critics of the 2012 recommendation blamed it for the rise in advanced prostate cancer cases, saying doctors had missed opportunities to focus on the disease at an early stage,” Laurie writes. “Others disagreed, saying the impact of the 2012 action wouldn’t show up in death rates so soon.”
OUCH: The Virginia Senate reconvened Tuesday for a possible vote on expanding Medicaid, but no bill immediately came to the floor as Democrats pulled back from a threat to deploy a “nuclear” procedural move, The Post's Laura Vozzella reports. Instead, the Senate will return in a week, a delay billed as a way to give senators more time to study the latest Medicaid expansion plan, which was announced the day before by a key GOP senator and the House’s budget chief.
The delay came with a change in tone from Senate Majority Leader Thomas Norment Jr., who for the first time publicly acknowledged that expansion is likely to pass the Senate -- even though Senate Republican leaders have so far delayed a floor vote, frustrating Democrats. The House has already backed the plan. The state would be the 33rd to expand Medicaid under the Affordable Care Act.
“I think there will be a dispositive vote next week,” Norment told reporters. “I think there is a probability it will pass. The question is, in what form?”
— The Trump administration got a nod yesterday to go ahead with its cuts to the Children's Health Insurance Program from the Government Accountability Office, which okayed the administration's proposal to cancel more than $7 billion in unused cash from the insurance program for low-income kids.
“In a report sent to congressional offices Tuesday morning, the GAO approved the vast majority of the administration’s $15.3 billion plan to cancel spending,” Politico's Sarah Ferris reports. “With that legal approval, the White House’s plan for so-called rescissions will likely retain its filibuster-proof powers in the GOP-controlled Senate, easing the way for potential passage with a simple majority vote.”
Democrats have criticized the administration's request to Congress for a budget "rescission” because it included cuts to CHIP. But the cuts wouldn't reduce the number of children with health insurance, the Congressional Budget Office has said, because the cuts would come out of CHIP's leftover and emergency funding.
— Mick Mulvaney, director of the White House Office of Management and Budget, writes in a Post op-ed that Democrats are showing "hypocrisy in its purest form" by yelling about the CHIP rescissions. Noting that Congress often claws back unspent funds, Mulvaney questions why Democrat leaders are now opposing the president's rescission plan even though they'd previously supported parts of it.
"It’s fascinating to watch Democrats in Congress spin a good-government proposal into a message of grave concern," Mulvaney writes. "In this instance, Trump is trying to return unspent government money to the taxpayers, while Democrats are demagoguing the effort as his attempt to hurt innocent children. 'Never let facts get in the way of a political attack' appears to be the Democratic mantra."
— In the several months since Trump and top Senate Republican Mitch McConnell were locked in a feud over the failed Republican effort to repeal and replace the Affordable Care Act, the pair’s relationship has markedly improved. “Now they are plotting together to keep control of the Senate in the midterm elections, with each realizing the other is crucial to his success,” our colleagues Sean Sullivan and Seung Min Kim report. “Their alliance is among the most fragile in U.S. politics, built on recent victories, including the sweeping Republican tax law and a spate of successful Senate primaries. That winning streak needs to continue to preserve the detente, numerous allies said.”
Trump and McConnell share almost no personality traits except a “deeply rooted desire to win,” Seung Min and Sean write. But certain efforts, such as their mutual success in preventing West Virginia's former coal baron Don Blankenship from getting the Republican nomination for Senate, have illustrated how critical it is for the pair’s relationship to function if the Republicans want to keep their majority this year.
“[T]he sprint toward the November elections is dotted with political land mines that could wreck their partnership and create havoc in the Republican Party,” our colleagues write. “Messy Senate races in Arizona and Mississippi could divide them and imperil the majority, while looming showdowns over government funding and Trump’s continued demands for a border wall threaten to spark new tensions.”
— The United States has pledged to provide $8 million to support the global response to the Ebola outbreak in Congo. Yesterday, HHS Secretary Alex Azar announced a $7 million commitment at the World Health Assembly in Geneva, an addition to $1 million the government pledged last week, our colleague Lena H. Sun reports. As of yesterday, 51 confirmed, probable and suspected cases and 27 deaths had been reported.
The pledge follows the World Health Organization's assertion late last week that a “vigorous response” from the international community is necessary to prevent an escalation in the outbreak. WHO said the outbreak does not yet meet the criteria to be declared an international public health emergency, though it is the most serious since the 2014 West Africa epidemic that killed more than 11,000 people.
Meanwhile, authorities began administering a vaccine for health workers in affected areas and plan to vaccinate 1,000 people in the next week. More than 7,500 doses of the vaccine have been sent to the region and another 8,000 are on the way, Lena reports.
“But enormous challenges lie ahead as officials and others race against the virus to identify people in the high-risk groups being targeted for vaccination: front-line and medical workers, persons who had contact with confirmed cases and then contacts of those contacts,” she writes. “The goal is to form a buffer of immune individuals to rapidly prevent the disease from spreading. The first batch of vaccines — one-dose shots — is enough to vaccinate 50 'rings' of 150 people, officials said.”
— A few more good reads from The Post and beyond:
- The Senate Health, Education, Labor and Pensions Committee holds an executive session on “Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018."
- The Senate Appropriations Subcommittee on Interior, Environment and Related Agencies holds a hearing on the Indian Health Service 2019 budget.
- The House Veterans Affairs Subcommittee on Economic Opportunity holds a legislative hearing.
- The Senate Banking, Housing and Urban Affairs Committee holds a hearing on the status of the “Housing Finance System."
- The House Energy and Commerce Subcommittee on Health holds a hearing on “Reauthorization of the Children’s Hospital Graduate Medical Education Program."
- The Brookings Institution holds an event on opioids.
- The Senate Finance Committee holds a hearing on rural health care on Thursday.
- The Brookings Institution holds an event on medical marijuana in the United States on May 29.
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