21st Century Cures legislation
House Passes 21st Century Cures, Bill Heads To Senate
The House passed Wednesday 21st Century Cures legislation 392-26, sending the sweeping FDA and CMS reform package to the Senate. Despite objections Wednesday by some prominent Democratic senators over certain provisions, Senate health committee Chairman Lamar Alexander (R-TN) says the bill has bipartisan support. Should the bill pass the Senate, it will likely be signed into law, according to a White House statement released Tuesday (Nov. 29).
“We are on the cusp of something special. A once-in-a-generation opportunity to transform how we treat disease. With today’s vote, we are taking a giant leap on the Path to Cures. Working together, we will deliver Cures Now,” Energy & Commerce Chairman Fred Upton (R-MI) said Wednesday prior to the House vote.
Senators critical of the bill, including Senate Democratic Whip Dick Durbin (IL) and Sens. Jeff Merkley (D-OR) and Elizabeth Warren (D-MA), criticized the bill Wednesday on the Senate floor.
Durbin raised concerns over using the ACA's prevention fund as an offset and the lowered NIH funding as compared to the 2015 House-passed bill. Durbin also acknowledged concerns made by Warren, who has been rallying progressives to oppose the bill.
“I think it is a step in the right direction but as Senator Warren has told us it's at a heavy cost when it comes to the favors included in this bill for people who have friends in high places when it comes to the United States Congress,” Durbin said.
Merkley argued the bill was not ready for consideration by the Senate, and listed the lack of mandatory funding as among the reasons for his opposition.
“This bill isn’t ready not just for prime time, it's not ready for consideration at all,” Merkley said. “If we're going to cut real programs to fund other real programs like the Moonshot and Alzheimer's research, strengthening NIH, then get it into this bill. Don't just put in the real cuts and say there’s some promise and an invitation to chase a rainbow down the road. Put it in the bill”
In the new 21st Century Cures certain regenerative therapies could be eligible for priority review and accelerated approval.The Alliance For Regenerative Medicine praised the new language, which was absent from previous versions of Cures, however Public Citizen cautioned that the provision deserved further scrutiny. The newly released language is different from a regenerative medicine bill being pushed by Senate Majority Leader Mitch McConnell (R-KY), which drew criticism from patient advocates.
The newly released Cures language would allow certain regenerative medicine products to receive priority review and accelerated approval, should they meet the criteria to be classified as a regenerative advanced therapy.
“A drug is eligible for designation as a regenerative advanced therapy ... if-- '(A) the drug is a regenerative medicine therapy (as defined in paragraph (8)); '(B) the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and '(C) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition,” states the bill.
The bill directs FDA to decide whether a product meets the regenerative advanced therapy criteria within 60 days of a request for designation.
Designation as a regenerative advanced therapy carries benefits for sponsors, which could include priority review, which requires FDA take action on an application within six months, as opposed to the typical 10 months. Designation also entitles sponsors to early communication with FDA to discuss endpoints to support accelerated approval.
However, the bill's accelerated approval language prompted concern from pubic health advocates.
An advanced regenerative therapy may be eligible for accelerated approval based on “'(i) surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; or (ii) reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate,” the bill states.
When asked if taking up the bill in the Senate could be stalled, the spokesperson told IHP that it was up to Senate Majority Leader Mitch McConnell (R-KY). McConnell has previously called the passage of the bill a top priority for the lame-duck session.
Despite opposition from some members of the Senate, Alexander stressed the bipartisan support for the bill in a Tuesday floor speech.
Alexander said: “[D]on't let anyone suggest to you that a bill that has $6.3 billion of appropriations that include Democratic priorities and bipartisan priorities and the core of it is 19 bills of FDA and NIH reform that have a Democratic sponsor for every single bill and that were approved by a 22-member committee...Don't let anybody say to you that this is not a bipartisan bill. Anyone who says that simply hasn't spent the time to be involved in the process.”
Alexander said Wednesday that the bill would be taken up by the Senate early next week. Upton said following House passage of the bill that he didn't expect any amendments in the Senate.
Alexander said Wednesday that the bill would come to the Senate on Monday, but did not give details on when the bill would be taken up.
The White House issued a Statement of Administration Policy Tuesday expressing strong support for the bill, despite lingering concerns it has with a handful of provisions.