House seeks momentum on medical cures

The House is looking to use an overwhelming bipartisan vote to raise pressure on the Senate over a medical cures bill on which the upper chamber has been lagging.

The House is moving forward on its 21st Century Cures measure, aimed at speeding up the FDA’s approval of new drugs and increasing funding for the National Institutes of Health.

{mosads}House Energy and Commerce Chairman Fred Upton (R-Mich.) has repeatedly said he wants to get a bill signed into law before the end of the year. 

But the Senate is still in the early stages of its effort on a similar bill, and Sen. Lamar Alexander (R-Tenn.), leading the effort, has said the timeline could slip into the start of next year, when the election could make bipartisan action more difficult.

“I would like to think that at some point late summer, early fall, whether it be July or September, they’ll actually get a bill that we can then marry in conference and get to the altar,” Upton told reporters Thursday, placing an emphasis on the “I.”

Rep. Joe Pitts (R-Pa.), the chairman of the Energy and Commerce health subcommittee, cited the bill to repeal Medicare’s Sustainable Growth Rate (SGR) earlier this year an an example of a bipartisan House vote putting pressure on the Senate.

Asked if the House and Senate could pass a bill this year, Pitts said, “We will.”

“They did the same thing on SGR, and basically followed our lead,” he added.

The cures bill easily passed Pitts’s subcommittee on a voice vote on Thursday, and will head to the full committee next week.

“By getting a big bipartisan push here like we showed today in subcommittee, likely next week, and then on the House floor in June, I think it sets the stage for a pretty good moment,” Upton said.

Alexander has provided a more relaxed timeline than Upton’s July or September hope.

“They’re ahead of us, it will take us until about the end of the year to finish our work here,” Alexander said Thursday.

He said the conference committee could come “at the end of the year or early next year.”

“I applaud the House’s effort with the Cures Act,” Sen. Richard Burr (R-N.C.), who is working with Alexander, said at an event hosted by The Hill this week. However, he added: “The Senate never moves quickly.”

Despite the differing timelines, both Upton and Alexander emphasize that they are in touch and working together.

Upton said he anticipates the Senate bill will be smaller and less comprehensive because the chamber has not had as long to work on it. Asked if that means the majority of the final bill will come from the House, he said, “Yeah, but we’re going to be working together.”

He added: “We’re working very closely with all the players, not only the stakeholders but also the administration, I think they’ve been pleased with what we’ve been doing.” 

The effort was one of the topics discussed at a private breakfast on Wednesday with Alexander, Upton and Secretary of Health and Human Services Sylvia Mathews Burwell.

The Obama administration has not yet publicly taken a position on the cures bill.

While the bill has received bipartisan support, the main obstacle ahead is figuring out how to pay for it. The legislation includes $10 billion over five years in mandatory spending to increase funding for the NIH, a key cost that will have to be offset.

Upton says the bill will be fully paid for, and more details on the offsets will come next week.

While the bill boosts NIH funding, it currently does not include more funding for the FDA, which Democrats have been pushing for.

Rep. Diana DeGette (D-Colo.), one of the lead Democrats working with Upton, said at the markup Thursday that if the FDA is not given more funding to aid in its approval of new cures “then we might as well not have the advances.”

Upton said that he also wants to see more funding for the FDA, but that the amount could depend on the Congressional Budget Office score of the bill.

One of the core elements of the measure so far is increasing the use of real world evidence of a drug’s effect, beyond clinical trials. It also encourages tracking the progress of certain biological measures instead of waiting for the full, definitive results of a trial, which can take much longer.

Democrats have pushed back on a provision extending for six months market exclusivity rights for drugs treating rare diseases, arguing it could raise drug prices by decreasing competition. The length of time in the exclusivity proposals has been reduced from the original version.

On the effort as a whole, Alexander said that the Senate is on a “parallel” track.

“We’re on basically the same subject and we stay in touch,” he said.