House approves medical cures bill in 344-77 vote

The House voted Friday to overwhelmingly approve a multi-billion dollar medical cures bill that supporters say will speed up new treatments for patients.

The 21st Century Cures Act passed 344-77.

The legislation includes $8.75 billion worth of new research dollars for the National Institutes of Health. It also overhauls the process that the Food and Drug Administration uses to assess and approve new medicines.

{mosads}While the measure passed out of committee in May on a rare 51-0 vote, it encountered some last-minute resistance this week from both parties.

Many conservatives objected that the NIH spending is mandatory, which does not force Congress to revisit it each year through the normal appropriations process. A total of 141 Republicans supported an amendment by Rep. Dave Brat (R-Va.) that would have made the funding discretionary, though the measure ultimately failed. One hundred Republicans opposed the amendment.

A total of 70 Republicans ultimately voted against the bill. 

Several Democrats condemned an abortion rider to the bill by GOP leadership, which would have applied Hyde Amendment language restricting federal funding for abortions. An amendment from Rep. Barbara Lee (D-Calif.) earned support from 176 Democrats, but it too failed.

The push for the bill was led by House Energy and Commerce Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.). The two lawmakers had traveled across the country for meetings with researchers and patients over the last year and a half to shape their bill.

Supporters of the legislation – which is also backed by most pharmaceutical and biomedical companies – argued the rare bipartisan accomplishment would save lives.

It marks the second time House leaders have struck a deal on healthcare this year, about three months after House Speaker John Boehner (R-Ohio) muscled through a repeal of Medicare’s sustainable growth rate.

Rep. Frank Pallone (D-N.J.), the top Democrat on the Energy and Commerce Committee, said he’s often struggled to give a satisfactory answer to advocates asking why there isn’t more research funding when he attends events promoting investments in cures for specific diseases.

“For 20 years, most of the time when somebody brings that up, I don’t really have an easy response,” Pallone said.

Now, Pallone said, “I’ll be able to say we have a bill called 21st Century Cures, and it does a lot of things that could make a difference.”

Upton fought back tears during floor debate as he noted how many people have died from diseases that robbed families of parents, children and spouses.

“We’ve all said too many early goodbyes. Too many,” Upton said.

The 350-page bill includes reforms to speed up the FDA’s review process, some of which have made medical researchers nervous about whether the agency could still uphold safety standards.  

Articles last month from a former FDA commissioner and two Harvard medical school professors warned about provisions in the bill encouraging the use of “real world” observational effects of a drug rather than more rigorous clinical trials. They also warned of the bill using preliminary measures known as biomarkers instead of waiting for the definitive results of a trial.

“21st Century Cures Act could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death,” David Kessler, a former FDA commissioner, wrote in The New York Times.

The Senate is working on its own version of the bill and appears unlikely to speed up its timeline. The bill’s House supporters say they hope it can go up for a vote in the fall, no later than December.

“We did it today with 344 votes and we’re very pleased about that,” Upton said at a press conference after the vote. “What this means is hopefully it will in fact trigger a similar reaction in the Senate.”

He said discussions had not yet begun with the Senate about whether the NIH funding would be mandatory or discretionary, but he pointed to the strong vote against the Brat amendment as showing the House’s support for mandatory funding.

“It was in essence a 2 to 1 vote and it shows where the House is,” he said. “We haven’t gotten into the details yet. That work will start probably next week.”

The bill’s original $10 billion in NIH spending was reduced to $8.75 billion amid wrangling over offsets. Leading Democrats say they see an opening to restore the full $10 billion in NIH funding through a Senate conference.

The main funding method is selling oil from the Strategic Petroleum Reserve, which some conservatives have criticized as a gimmick.

“We spent two years talking about $10 billion in mandatory funding and then just last week, because of Republican conference issues, we had to drop it back,” Rep. Gene Green (D-Texas) said.

This story was updated at 12:31 p.m.