House leaders push back on criticism of cures bill

Bipartisan House committee leaders on Tuesday pushed back against concerns that a medical cures bill they are backing could endanger patients by setting the standards for drug approval too low.

{mosads}The 21st Century Cures Act has received bipartisan support and passed out of the Energy and Commerce Committee on a rare 51-0 vote last month. Committee leaders are working out the final details and hope to send the bill to the full House soon. 

The legislation aims to streamline the Food and Drug Administration’s approval of new drugs and also provides $10 billion over five years for research at the National Institutes of Health. 

However, some are warning that it goes too far in its bid to speed up the FDA’s approvals. 

For example, articles this 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.

But bipartisan Energy and Commerce leaders pushed back when asked about the concerns at a press conference on Tuesday.    

“Sometimes I feel like there are those out there who say that any change we make to the way FDA approves drugs and medical devices inherently will mean that the byproduct is not safe, and that’s not true,” said Rep. Frank Pallone (N.J.), the committee’s top Democrat.

Rep. Diana DeGette (D-Colo.) pointed to increased patient participation in FDA review panels as helping increase safety. Second, she pointed to increased funding for the FDA, at $550 million over five years. Third, she pointed to “post-market review” follow-up studies after a drug’s approved. 

“We’ve increased and beefed up post-market review so that we can make sure that any of these studies that happen are good when they’re approved, but then there’s also robust post-market review,” she said. 

Chairman Fred Upton (R-MIch.) pointed to increased funding for the FDA. 

“We all want safe drugs and devices,” he said. “We know that we can streamline the process, but we also knew that we had to add to FDA’s resources for what we’re asking, demanding them to do, and we do that.”

David Kessler, a former FDA commissioner, in The New York Times last week wrote that the “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.”

Similarly, the Harvard medical school professors Jerry Avorn and Aaron Kesselheim warned against the bill in the New England Journal of Medicine this month. 

The FDA, they note, already “approves new medications about as quickly as any regulatory agency in the world.”

Still, the bill has won support from a broad range of advocacy groups, including the American Cancer Society’s Cancer Action Network and the National Health Council. 

“We would like to think it would be on the House floor very shortly, once we work out a couple little concerns,” Upton said. “We are not quite ready to tell leadership that we’re there yet, but it will be soon.”

He declined to elaborate on what the remaining issues are. 

The offsets of the bill’s $13 billion, which include cuts to insurers under the Medicare Advantage program and reduced payments for medical equipment, have drawn objections from industry groups. 

Upton said his goal is 350 votes in the House, which he hopes will spur the Senate to speed up on its own bill so that a measure can be signed into law this year. 

A strong vote, he said, “sends the right signal to the Senate, that they’ve got something good over there in the House.”