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Capitol Checkup: Right-to-try vote; CMS gag threat; new VA pick; NIH Ebola-ready

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Capitol Checkup: Right-to-try vote; CMS gag threat; new VA pick; NIH Ebola-ready

House Republicans this week will try to push through a bill passed last year by the Senate aimed at giving critically ill patients greater access to experimental drugs beyond the U.S. Food and Drug Administration's current compassionate-use process.

Republicans have decided, for the time being, to abandon a different version of the so-called right-to-try bill passed in March by the House, which Senate Majority Leader Mitch McConnell, R-Ky., has let sit unattended by his chamber.

The House Rules Committee is expected to hold an evening session May 21 to set the terms and conditions for debating and voting on the Senate-passed bill.

FDA Commissioner Scott Gottlieb last fall objected to the Senate's bill, telling House lawmakers then that the legislation contained flawed criteria, which he said could expose more people unnecessarily to potentially dangerous side effects.

But the FDA chief has since reversed course — tweeting May 17 that he was now "comfortable" with the Senate legislation, though the bill, authored by Sen. Ron Johnson, R-Wis., has not changed since the chamber passed it in August 2017.

"To be clear, FDA supports the Johnson bill moving to [the] House floor and stands ready to implement it in a way consistent with the intent of Congress to promote access and protect patients," Gottlieb wrote on Twitter.

President Donald Trump has pressed Congress to pass the legislation and has publicly pressured Gottlieb to quickly implement it.

"Right to try is happening, right? You have that moving?" Trump said during a May 11 speech, pointing to Gottlieb.

Vice President Mike Pence has also pushed Gottlieb to work with lawmakers to get the right-to-try legislation done.

Critics of the legislation — including former biotech executive Michael Becker, president and founder of MDB Communications LLC, who has been diagnosed with terminal cancer — have argued that the measure would cut the FDA out as a gatekeeper, leaving desperately ill patients potentially exposed to "snake oil" salesmen peddling false hopes.

Rep. Frank Pallone, D-N.J., ranking member of the House Energy and Commerce Committee, has said the right-to-try movement is an "egregious attempt" to "undermine the FDA" by the libertarian Goldwater Institute.

At the October 2017 hearing, Gottlieb acknowledged that the FDA does not have the authority to force drugmakers to provide their experimental medicines to patients, and the Johnson legislation would not change that situation.

He also noted the FDA already has a long-running expanded access program, also known as compassionate use, under which regulators help terminally ill patients obtain and use investigational medicines outside of the clinical trial process.

Gottlieb said the FDA approves 99% of the 1,000 compassionate-use program applications it receives annually from patients, with most given the go-ahead within a few days and emergency requests generally granted immediately over the phone.

Last fall, Gottlieb expressed concern that the "life-threatening disease or condition" criteria in the Johnson bill may be interpreted broadly and "could sweep in a whole range of conditions for which we didn't intend," such as chronic conditions, like diabetes.

"If the goal is to make sure that we're serving the interests of patients who are facing terminal illnesses, the more we broaden this provision and the more we potentially sweep in conditions for which we might be exposing people to unwanted side effects from experimental therapies, the more we risk undermining the whole venture that we're trying to engage in here, which is to narrowly tailor something to people who really don't have good options from available therapy," he said. "I think the way this is currently written it could undermine some of the goals of the policy."

Gottlieb said the FDA's attorneys also told him "we'd have to interpret that broadly."

"I don't think that we'd be able to, as a matter of our own interpretation of the law, further narrow that," he testified. "I think if anything, we would have to interpret that fairly expansively."

Gottlieb urged the House last fall to adopt a narrower definition of patients diagnosed with a terminal illness — a request the chamber met in the bill it passed.

Now, though, House Republican leaders are tossing out their bill and are moving forward with trying to pass the Senate's version — an outcome that appears likely. And Gottlieb is backing the Johnson bill, despite his earlier testimony.

Becker told S&P Global Market Intelligence he thought Gottlieb's "about-face" was because he "fears being terminated by his boss if he doesn't help pass this legislation."

"But job security isn't a reason to pass this bill," Becker said.

He also noted that patients could lose insurance coverage if they use an unapproved medicine — a problem Johnson's bill does not address.

CMS says 'gag clauses' unacceptable

The Centers for Medicare and Medicaid Services, or CMS, on May 17 told prescription drug plans participating in the Medicare Part D program that the agency would no longer tolerate so-called gag clauses in pharmacy contracts.

The clauses prevent pharmacists from telling customers when they can pay less out-of-pocket costs for their prescription medicines by not using their insurance plans.

"We want to make it clear that CMS finds any form of 'gag clauses' unacceptable and contrary to our efforts to promote drug price transparency and lower drug prices," the agency said in a letter sent to the plans.

CMS did not say what type of actions it would take against the plans if they continue to use gag clauses in their contracts.

The agency said the warning letters were part of Trump's plan to lower prescription drug prices, which he unveiled May 11.

On Capitol Hill, lawmakers also have been working on bipartisan legislation to try to ban gag clauses, including in Medicare plans.

Trump surprises acting VA chief with nomination

During a May 18 White House event, Trump surprised Acting Veterans Affairs Secretary Robert Wilkie with the news he was the president's latest pick to permanently lead the agency.

"I'll be informing him in a little while — he doesn't know this yet — that we're going to be putting his name up for nomination to be secretary" of the VA, Trump said from the East Room of the White House during a summit on prison reform.

Wilkie, a lawyer, has been temporarily filling in as head of the VA since late March after Trump fired now-former Secretary David Shulkin via Twitter.

Trump initially selected his White House doctor, Rear Admiral Ronny Jackson, to take over the VA, but that nomination quickly fell apart after questions were raised about his lack of qualifications and accusations emerged of him improperly dispensing controlled substances, engaging in excessive drinking on the job and creating a hostile work environment.

Jackson denied any wrongdoing but withdrew from consideration.

The Senate's McConnell called Wilkie an "outstanding choice" to serve as VA chief.

House Minority Leader Nancy Pelosi, D-Calif., urged Wilkie to resist any attempts to privatize the VA.

NIH on alert but ready for Ebola

The U.S. National Institutes of Health is on "very high alert" and remains concerned as the global health community responds to the current Ebola outbreak in the Democratic Republic of the Congo, said Anthony Fauci, the agency's top infectious disease expert. But the NIH is cautiously confident there are a number of countermeasures able to block the spread of the deadly virus, he told lawmakers last week.

Those vaccines and medicines are the "fruits of the work" the NIH was engaged in during the 2014-15 Ebola epidemic that plagued the West African nations of Guinea, Liberia and Sierra Leone, Fauci explained during a May 17 hearing of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies.

He noted the experimental vaccine from Merck & Co. Inc. that is being used in the DRC to try to prevent an epidemic was first tested at the NIH's Clinical Center in Bethesda, Md.

In addition, a number of doses of Mapp Biopharmaceutical Inc.'s experimental drug ZMapp — a cocktail composed of three humanized monoclonal antibodies manufactured in tobacco plants bioengineered specifically to produce large quantities of the proteins — are also being shipped to the DRC, said Fauci, who leads the NIH's National Institute of Allergy and Infectious Diseases.

He said the NIH was also partnering with Gilead Sciences Inc. on some new monoclonal antibodies to treat Ebola.

"Our expectations are always cautious, but the hopes are we will not have the kind of outbreak that we saw in West Africa," he told lawmakers.

Earlier this month, however, Trump called on Congress to rescind the remaining $252 million from the U.S. 2015 Ebola response funds as part of his $15.4 billion rescission edict. He also dismantled the White House's global health security team.