FDA User Fee Reauthorization Poised To Pass House of Representatives

On Monday, the House of Representatives released the latest version of the proposed Food and Drug Administration (FDA) user fee reauthorization bill. The House is expected to vote on the must-pass bill as early as today, but the Senate has not yet set forth its own timeline for voting on the bill. I have previously written here about the version of the bill marked up in the Senate, and about the committee staff’s valiant efforts to keep the bill free of politically controversial provisions. In this post, I review some of the key provisions in the newly released bill and consider its implications for the FDA. Widespread Agreement Between the Senate And House Bills With one exception (as noted below), the bill includes few surprises for those who have followed the markups in the Senate and House. The two amendments added in the Senate hearing—Senator Hatch’s (R-UT) expanded access amendment and Senators Collins’s (R-ME) and Franken’s (D-MN) generic competition amendment—are included as sections 610 and 801 of the bill. Importantly, small changes have been made to both of those amendments. Most are not substantive. For instance, as voted on in the Senate, the generic competition amendment gave the FDA “240 calendar days” to act on the submission of a priority generic, while section 801 of the House bill gives the FDA “eight months” to act. Several changes in the expanded access amendment impact scheduling, although perhaps not significantly. As one ex...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Drugs and Medical Innovation FDA orphan drugs user fees Source Type: blogs