FDAnews Drug Daily Bulletin

Follow-On Biologics Will Not Make PDUFA, Enzi Spokesman Says

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Lawmakers have agreed that follow-on biologics legislation will not be part of the final FDA Revitalization Act (FDARA), a spokesman for Sen. Mike Enzi (R-Wyo.) said.

“There is a general agreement the [follow-on biologics] will not be part of the conference agreement for FDARA,” the spokesman said. He added that Enzi and other lawmakers intend to take up follow-on biologics at another time.

The bill is currently pending before a conference committee to work out issues between the House and Senate versions. The Senate version of FDARA, S. 1082, contains a placeholder for follow-on biologics legislation, while H.R. 2900, the House version, does not. 

FDARA would reauthorize the Prescription Drug User Fee Act (PDUFA), which expires Sept. 30. Enzi recently criticized House Democrats for considering delaying the bill.

Without the issue of follow-on biologics, the difference between the House and Senate FDARA bills is not complicated, which should allow the bill to pass before PDUFA expires, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood said recently.

Approving legislation for follow-on biologics can happen in a separate bill in the future, Enzi said. “I believe that we can reach an agreement to do just that by going through regular order, as my colleagues in the House have been requesting for months,” he added.