FDARA May Advance More Swiftly After Failure of BCRA

On Monday night, Senators Mike Lee (R-Utah) and Jerry Moran (R-Kansas) announced their opposition to the Republican healthcare reform bill, the Better Care Reconciliation Act (BCRA). Senators Lee and Moran joined Senators Rand Paul (R-Kentucky) and Susan Collins (R-Maine) in saying that they would not support the bill, leaving Senate Majority Leader Mitch McConnell 2 votes short of the number needed to pass the act. This final blow to the BCRA comes after a vote on the bill was delayed in order to allow Senator John McCain (R-Arizona) to recover after undergoing surgery last week.

In his formal announcement of his opposition to the bill, Senator Moran said, “There are serious problems with Obamacare, and my goal remains what it has been for a long time: to repeal and replace it. This closed-door process has yielded the BCRA, which fails to repeal the Affordable Care Act (ACA) or address healthcare’s rising costs. For the same reasons I could not support the previous version of this bill, I cannot support this one.” Senator Lee said in his own statement that he could not vote in favor of the act because it “doesn’t go far enough in lowering premiums for middle class families; nor does it create enough free space from the most costly Obamacare regulations.”

Senator McConnell said that “the effort to repeal and immediately replace the failure of Obamacare will not be successful,” and added that Republicans now plan to repeal the ACA without immediately proposing new legislation to take its place. Such a move could have cascading consequences for the biosimilars industry; the Biologics Price Competition and Innovation Act, which established an accelerated approval pathway for biosimilar products, was passed into law as part of the ACA. The Washington Post reports, however, that many centrist Republican lawmakers are opposed to a straight repeal of the Obama-era legislation, and that such a repeal would be unlikely to pass.

The uncertain future of Republican healthcare reform has created an opportunity for the FDA Reauthorization Act, passed by the House last week, to reach a vote more quickly. Senator McConnell placed the FDARA on the Senate’s calendar on Monday, moving the bipartisan bill a step closer to its expected passage. While McConnell has not yet disclosed a date for a Senate vote on the FDARA, some have suggested that the failure of the BCRA could allow lawmakers time to vote on the reauthorization plan for user fees sooner rather than later.