Follow-On Biologics White Paper From FDA Could Be Delayed Until Fall
This article was originally published in The Pink Sheet Daily
Executive Summary
Policy implementation is likely to require agency action before legislative initiatives, according to Reed Smith attorney Deborah Shelton.
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An FDA white paper outlining the history of follow-on biologic policy development is now expected in late summer to fall, the agency said. The paper had been projected for release in August. The white paper is to be followed by a series of guidance documents. Three subsequent guidances are planned: one on policy and two technical guidances on characterization and immunogenicity, FDA said. To gather industry comments, FDA has held two workshops with representatives from branded and generic companies (1 (Also see "FDA Follow-on Proteins Draft Guidance Will Be Followed By Third Public Meeting" - Pink Sheet, 14 Feb, 2005.)). FDA guidances are a critical first step to advancing generic biologics regulations, Reed Smith attorney Deborah Shelton said at the Strategic Research Institute Generic Biopharmaceuticals Global Summit Aug. 2 in Washington, D.C. The agency needs to make progress in its work on "the scientific and technical issues" before legislation on the topic can be enacted, Shelton said. "Legislative initiatives continue to take a back seat to FDA's resolution of scientific issues," she said. In February, Senate HELP Committee Health Policy Staff Director Stephen Northrup said that legislative action should be the next step for generic biologics regulation (2 (Also see "Follow-On Biologics Should Be Handled Through Legislation – Senate Staffer" - Pink Sheet, 10 Feb, 2005.)). However, Shelton declared that Committee Chair Mike Enzi (R-Wyo.) "is now back to wanting FDA to continue to carry the ball on this and really address the scientific issues first before getting into the legal issues and trying to create a legal framework." - Kathleen Michael |