House Energy & Commerce Chair Greg Walden (R-OR) told Inside Health Policy Tuesday (Feb. 6) he does not believe House leadership will heed calls from sponsors of a pending Right to Try bill to bypass the E&C committee and send the Senate-passed bill directly to the House floor. Walden and his staff are currently working with FDA on yet-to-be revealed compromise language, but a representative for the think tank behind the bill says that the language floated would be unsatisfactory.

The push for a federal Right to Try law, which would let terminally ill patients buy drugs that aren’t FDA approved and cut FDA entirely out of the process, has been reinvigorated in recent weeks following President Donald Trump’s calls for the policy during both his State of the Union and a speech the next day at the GOP retreat. The Senate passed a Right to Try bill via unanimous consent last August but the House bill has been stuck in the Energy & Commerce Committee.

Starlee Coleman, senior policy adviser at the Goldwater Institute, the libertarian think tank behind the push for the bill, told Inside Health Policy that Trump’s remarks created quite a bit of pressure on lawmakers to get the policy across the finish line. Coleman noted that following Trump’s remarks, White House policy staffers have gotten involved in the issue, which was previously championed by the vice president’s office.

House sponsors of the pending bill, Reps. Andy Biggs (R-AZ) and Brian Fitzpatrick (R-PA), as well as Senate sponsor Sen. Ron Johnson (R-WI) met with House Speaker Paul Ryan (R-WI) and House Majority Leader Kevin McCarthy (R-CA) Monday (Feb. 5).

Biggs and Fitzpatrick presented Ryan and McCarthy with a letter urging them to bypass the Energy & Commerce Committee and bring the Senate-passed bill directly to the House floor. “Unfortunately, the House has not acted despite the fact that S. 204 passed the Senate by unanimous consent on August 3 of last year. Moving forward, placing S. 204 on the suspension calendar would be the best and most expedient way to proceed, and we have no doubt that such an effort would be successful,” the letter states.

Walden told IHP Tuesday that he doesn’t believe Ryan and McCarthy will honor the sponsors’ request. Neither Ryan’s nor McCarthy’s offices could be reached for comment on the meeting.

“No, I do not believe the leadership is going to bypass the Energy & Commerce Committee. That would be fraught with all kinds of peril. That’s just me being a German here — but also because I’ve worked closely with Kevin McCarthy, the speaker and the Vice President of the United States and Scott Gottlieb,” Walden said.

Walden is working with FDA on compromise language, which he says answers calls from patient advocates for tweaks to the Senate bill.

“We want to get a Right to Try bill that will work for patients, we think we are very close on language. I’m dedicated to this cause as well. It’s just that we think if you listen to the patient groups, they tell us that there are problems with the way the language is drafted that came over from the Senate. And so they’re asking us — the people representing patients are asking us — to make some improvements so that this will be an effective piece of legislation. I think we are very close on that piece,” Walden told IHP.

FDA Commissioner Scott Gottlieb also confirmed Tuesday that FDA is providing E&C lawmakers with technical assistance.

“As you know, trying to facilitate access to treatments for patients who face terminal [a] diagnosis has been a high priority of the administration. You’ve seen the vice president and president talk about this. It’s certainly a high priority of mine, it’s a high priority of FDA’s — it has been historically. We’ve done a lot of work both on my watch as well as before I got there trying to improve the expanded access program…I think we’ll get there. There’s a lot of people interested in this both in the patient community, obviously the administration and also on Capitol Hill. So I think we’ll be able to work out a proposal that can accomplish all the goals,” Gottlieb said during a briefing cosponsored by the Alliance For A Stronger FDA and the Pew Charitable Trusts.

When asked what FDA wants changed, Gottlieb referred back to his previous testimony to the Energy & Commerce Committee. Gottlieb had urged lawmakers to substantially tweak the Senate-passed bill, including: narrowing the patient population covered, further restricting promotion and commercialization of the experimental drugs, ensuring FDA’s authority to take certain enforcement actions and protecting FDA from federal tort liability.

A coalition of patient groups penned a letter Tuesday to Ryan and House Minority Leader Nancy Pelosi (D-CA) opposing the bill. “Any further action taken to advance the Right to Try legislation currently under consideration in the House is not in our patients’ best interests. As you consider bringing this troubling legislation to the House floor for a vote we ask that you remain mindful of our concerns, and take into consideration the negative impact the policies could have on patients living with life threatening disease,” nearly 40 patient groups including the National Organization for Rare Disorders, American Cancer Society Cancer Action Network, National Health Council and Friends of Cancer Research, wrote.

The groups also expressed their willingness to work with legislators on an alternative. “We welcome the opportunity to work with all members of the House of Representatives to develop alternative legislative proposals that would improve the ability of patients to genuinely and safely access both approved and unapproved innovative, lifesaving therapies,” the letter states.

But Coleman tells IHP language is being floated in the E&C Committee that would further reform FDA’s existing expanded access program and keep FDA as a gatekeeper to patient’s access to these drugs.

Coleman maintained that while reforms to the program could be good, any policy that keeps FDA in a role of granting or denying permission to a patient is not Right to Try — and FDA’s ability to “veto stamp” a request is what the organization is trying to remove.

Goldwater Institute supports the idea of bringing the Senate-passed bill directly to the House floor. Coleman argued that Right to Try policy has already been vetted in all 50 states and that there is no reason to keep talking about the bill.

Should any changes to the bill be made in the House, the Senate would then need to pass a new version of the bill. 

https://insidehealthpolicy.com/daily-news/walden-house-leadership-will-…