United States: Capitol Hill Healthcare Update - March 2018


The House will vote Tuesday on updated but still controversial legislation that would give terminally ill patients wider access to prescription drugs that haven't won approval by the Food and Drug Administration.

House Energy and Commerce Committee Chairman Greg Walden, R-Ore., said the "right-to-try" bill would be a modified and more narrow version of legislation introduced earlier by Reps. Brian Fitzpatrick, R-Pa., and Andy Biggs, R-Ariz.

The new bill – which would apply only to drugs, not medical devices – would narrow patient eligibility compared to the earlier legislation and also bolster the informed consent process for accessing unapproved drugs.

The Senate last summer approved right-to-try legislation backed by Sen. Ron Johnson, R-Wisc. But House leaders – including Walden – had been cool to the idea, warning it could give patients false hope while also undermining ongoing clinical trials. But after Vice President Mike Pence personally intervened with Walden and President Donald Trump touted the legislation in his State of the Union address in January, House leaders moved from blocking the bill to working on a compromise.

Many pharmaceutical manufacturers oppose the legislation, saying the FDA's existing compassionate-use program provides appropriate access under agency supervision.


Congressional leaders hope to finalize a $1.2 trillion budget bill before a deadline next week as lawmakers advocate for changes that would target pharmaceutical manufacturers.

Congress last month reached agreement on total spending for this fiscal year, but now lawmakers face a March 23 deadline to finalize funding specifics for dozens of individual departments and agencies, and thousands of federal programs. Lawmakers will add $6 billion to crack down on opioid abuse and boost medical research at the National Institutes of Health and veterans' healthcare programs.

But rank-and-file lawmakers also are seeking to attach policy priorities, including making it easier for generic manufacturers to obtain branded drugs for bioequivalence testing, specifically drugs under the FDA's risk evaluation and mitigation strategies safety program. House and Senate GOP leaders have long opposed the so-called CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act), legislation that would also make it easier to bring lawsuits and levy financial penalties against branded manufacturers, but advocates are making a last-minute push to add the bill.

The branded drug industry is also fighting to roll back a change Congress adopted last month that would require manufacturers to contribute more toward closing the so-called donut hole in the Medicare Part D prescription drug benefit. In a move that has split the industry, some companies are willing to include a form of CREATES in the budget bill if, in return, lawmakers lower the required industry contribution to eliminating the donut hole, which increased from 50 percent to 70 percent.

Some key leaders also want the budget bill to include government subsidies to stabilize the Affordable Care Act's insurance market and hold down premiums for individuals. That bill is backed by key healthcare lawmakers like House Energy and Commerce Committee Chairman Greg Walden, R-Ore., and Senate HELP Committee Chairman Lamar Alexander, R-Tenn. But it's not clear whether the subsidies could win approval in the House, where some lawmakers object to propping up ACA plans or using government funds to subsidize insurance plans that offer abortion coverage.

The House hopes to vote on the budget bill by the end of the week, giving the Senate time to approve the spending measure next week before the March 23 deadline.


Department of Health and Human Services Secretary Alex Azar will be on the Hill this week to defend the White House's $68 billion funding request for his department for fiscal year 2019.

Azar will appear Thursday before the House appropriations subcommittee that oversees HHS' budget.

In addition to questions on HHS' budget, Azar is likely to receive questions about his plans to update Medicare and Medicaid payment models as well as on the details of efforts to reduce prescription drug prices.


The Senate HELP Committee is holding a hearing this Thursday on the 340B prescription drug discount program.

The committee, which didn't release a witness list, has jurisdiction over the Health Resources and Services Administration, which has come under criticism from Congress for what lawmakers say is lax oversight of the 340B program.

House Energy and Commerce Committee Chairman Greg Walden, R-Ore., said his panel also will be holding 340B oversight hearings in the coming weeks. Although the schedule hasn't been announced, the hearings are unlikely to take place before Congress adjourns later this month for a two-week spring recess.

House and Senate lawmakers have introduced 340B bills in recent weeks, including to boost transparency among 340B hospitals and block a Trump administration rule to scale back 340B discounts.


Bipartisan legislation introduced in the Senate last week would prohibit Native American tribes from using sovereign immunity to block patent challenges.

The senators say their bill is in response to Allergan's attempt to thwart patent challenges of its eye treatment drug Restasis by selling those patents to the Saint Regis Mohawk Tribe in New York. The tribe is claiming its sovereign immunity shields the patents from certain reviews by generic drug manufacturers.

The move by Allergan was widely seen as a way to protect its $1.5 billion franchise. The drug company paid the tribe a one-time payment of $13 million plus $15 million annually for licensing. Allergan and the tribe are appealing a U.S. patent board ruling last month that tribal sovereign immunity can't be used to protect drug patents from certain reviews.

Sen. Tom Cotton, R-Ariz., said some drug companies "game the system [with] sham transactions" that harm consumers and increase drug prices for seniors. Other lawmakers backing the bill include Sens. Claire McCaskill, D-Mo., Pat Toomey, R-Pa., Joni Ernst, R-Iowa and David Perdue, R-Ga.

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