Eleven members of the House of Representatives have called on Congressional leaders to keep a provision establishing a regulatory pathway for FDA approval of follow-on biologics out of a comprehensive drug safety bill.

Differing versions of the drug safety legislation, officially the Prescription Drug User Fee Act (PDUFA), have been passed by the House and Senate, and a conference committee is expected to meet next month to come up with a final bill for enactment.

With key House and Senate staffers already meeting to explore possible compromises, the 11 members of Congress sent a letter to key House and Senate conferees asking them to not try to add provisions for follow-on biologics to the legislation.

The Senate version of PDUFA contains a placeholder that would enable the legislation on biosimilars to be added in conference, and Sen. Edward M. Kennedy (D-MA), whose committee approved a follow-on biologics bill in June, at one point indicated he intended to try to do just that.

But the full Senate has not considered the bill passed by Kennedy's committee, and the House has taken no action thus far on two different bills addressing regulation of biosimilars.

Congress should only consider follow-on biologics after full deliberations, hearings and committee action on the legislation in both chambers, the letter contends.