House Passes Omnibus FDA Reform Bill

Late Wednesday, the House of Representatives passed, by a vote of 403-16, H.R. 2900, “the Food and Drug Administration Amendments Act of 2007.”  The Senate passed its version of omnibus FDA reform legislation in May 2007 — S. 1082, “the Food and Drug Administration Revitalization Act” (“FDARA”) (Unfortunately, the House version does not lend itself to a good acronym, “FDAAA”).  A draft House Report on H.R. 2900 (that when finalized will be assigned #110-225) circulating on Capitol Hill is available here.

H.R. 2900, like S. 1082, reauthorizes the Prescription Drug Use Fee Act (as PDUFA IV) (FDC Act §§ 735-736), the Pediatric Research Equity Act (FDC Act § 505B) and the Best Pharmaceuticals for Children Act (FDC Act § 505A), and includes provisions amending the FDC Act with respect to so-called blocking citizen petitions, among other things.  There are differences between the two bills, however. H.R. 2900 does not include provisions on transferable priority review, enantiomer exclusivity, and “old” antibiotics.  In addition, H.R. 2900 does not include the “blockbuster drug” provision in S. 1082 that would limit pediatric exclusivity to 3 months for drugs with annual sales over $1,000,000,000.  These differences will be ironed out in conference committee debate.   

Neither the House nor Senate FDA bills include provisions on biogenerics.  It is our understanding, however, that language similar to that included in S. 1695, “the Biologics Price Competition and Innovation Act of 2007,” will be added in conference committee.  S. 1695 would amend the Public Health Service Act to add § 351(k) to provide for an approval pathway for “biosimilar” and “interchangeable” biologics that rely, in part, on FDA’s previous licensure of an innovator’s product.  In addition, the bill provides a 12-year period of innovator marketing exclusivity, limited “generic” exclusivity under certain circumstances, and patent resolution provisions.