FDARA May Be Delayed, But So Are FDA Layoffs

The Senate may not consider the FDA Reauthorization Act (FDARA) until early September, after the congressional recess. The delay comes after Senator John McCain (R-Arizona) returned to the capitol to vote in favor of advancing a debate over healthcare reform.

While many expected the FDA Reauthorization Act of 2017 (FDARA) to move more swiftly through the Senate after the Better Care Reconciliation Act failed to garner enough votes to pass the chamber, Inside Health Policy reports that the Senate may not consider the FDARA until early September, after the congressional recess. The delay comes after Senator John McCain (R-Arizona) returned to the capitol to vote in favor of advancing a debate over healthcare reform—a debate that left the Senate little room to debate any other proposed legislation.

The bipartisan FDARA, which would reauthorize user fees for biosimilar product applications, among other provisions, was passed by a voice vote in the House earlier this month. To ensure funding for the continued operations of the FDA, the Senate must pass the bill by the end of September.

Debate over the bill is likely to include the consideration of amendments that dominated committee meetings, including Senator Bernie Sanders’ (I-Vermont) drug importation amendment that would allow the importation of cheaper drugs from Canada. Sanders voted against advancing the FDARA out of committee after his proposed amendment was tabled.

The Senate is also likely to debate Senato Ron Johnson's (R-Wisconsin) “right to try” legislation, which would allow patients who have terminal illnesses to try as-yet unapproved experimental treatments. Johnson has declared that he will attempt to prevent the bill from passing unless it includes his proposed amendment.

According to Inside Health Policy, the debate could also focus on the cosmetics bill floated by Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine), which would grant the FDA the authority to issue recalls on cosmetic products, as well as Senator Johnny Isakson’s (R-Georgia) over-the-counter monograph bill that would provide a user fee program and potential 2-year exclusivity for over-the-counter drugs.

While the Biosimilar User Fee Act will expire at the end of September, FDA Commissioner Scott Gottlieb, MD, has indicated that he will delay any layoffs of FDA staff until the reauthorization deadline has passed.

In a letter to his staff, Gottlieb acknowledged that the perceived uncertainty surrounding the FDARA’s passage has been disruptive to employees on both personal and professional levels. However, he said, “because we can reasonably expect that there will be timely reauthorization of the User Fee programs by Congress by September 30, we do not anticipate initiating the process of making a determination regarding potential [reduction in force] notices unless and until September 30 passes without reauthorization.” However, he left open the possibility that the Senate might not take any action on this front, saying that, “Should Congress fail to reauthorize the User Fee programs by September 30, we will reassess our obligations at that point in time. However, my conversations with members of the Senate leave me with a high degree of confidence that the User Fee programs will be reauthorized before this September 30 deadline.”