House approves the 21st Century Cures Act, sending landmark bill to Senate

WASHINGTON — After three years of debate, countless hearings, and pleas from patient advocates, lawmakers on Tuesday approved legislation to speed new medicines to market and to authorize an additional $4.8 billion in spending for medical research.

The House of Representatives passed the 21st Century Cures Act by a 392 to 26 vote, showing a bipartisan spirit that has been rare in recent years. The Cures Act now heads to the Senate, for a vote early next week.

Supporters in Congress and patient advocacy groups said they were thrilled by the bill’s passage.

“We are on the cusp of something special — a once-in-a-generation opportunity to transform how we treat disease,” said Representative Fred Upton (R-Mich.), who marshaled the legislation through the House. “With today’s vote, we are taking a giant leap on the path to cures.”

The Cures Act includes numerous provisions that set the stage for the faster approval of prescription drugs and medical devices. Although proponents claim these new measures will not lower safety standards, numerous critics, including some former Food and Drug Administration officials and national consumer groups, disagree. They have argued that FDA already moves faster than similar agencies in other countries.

The landmark legislation provides $4.8 billion for the three signature Obama administration research programs over the next 10 years: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative. It would also give states $1 billion to fight the opioid crisis, and deliver an additional $500 million to the FDA.

The bill heads to the Senate for a vote early next week. Senator Harry Reid (D-Nev.), the minority leader, acknowledged that there had been “angst” over the legislation among his colleagues, and several, including Senators Elizabeth Warren (D-Mass.) and Dick Durbin (D-Ill.), have said they will oppose it.

But party leaders on both sides of the aisle said they expect the bill to pass the Senate.

To lawmakers, that promise of extra funds — and the prospect of having to justify a vote against cancer research and efforts to fight opioid addiction — has trumped any other objections to the bill. Even critics acknowledged the bill included welcome measures.

Representative Tim Murphy (R-Penn.), who voted for the bill, was a driving force behind provisions that will fund mental health care programs.

“To all the families who brought their stories out of the shadows, that dared to share their sorrows, their hopes, their shattered dreams, today is a day of joy,” said Murphy, who is a psychologist.”And today is only possible, I say to all those families, because they dared to step forward.”

Critics had a host of concerns. Representative Rosa DeLauro (D-Conn.) said the bill would weaken regulations on medical devices, allow drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rush the use of new and unproven antibiotics.

Dr. Michael Carome, director of Public Citizen’s Health Research Group, said he was especially concerned about Cures Act provisions that will allow the FDA to consider “real world evidence” when approving drugs and allow companies to submit summaries of study data, rather than full clinical trial records.

“The summary data could hide important information about the safety and effectiveness from the FDA scientist reviewing the data,” Carome said. “I’m disappointed to see it. ’’

This was the second time that the House approved the Cures Act, which the chamber initially passed by an overwhelming margin in July 2015. Since then, it has been a long slog.

In the Senate, lawmakers split down party lines. Democrats would not approve the accelerated approval provisions unless funding for the National Institutes of Health and the FDA was included. For their part, Republicans said they would not support mandatory funding without figuring out how to pay for it.

Read the full article by Sheila Kaplan