Hatch, Waxman urge FOB guidance

Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.) urged acting FDA Commissioner Andrew von Eschenbach to release guidance documents clarifying the approval requirements for follow-on versions of insulin and human growth hormone (hGH). In a Feb. 10 letter, Hatch and Waxman asserted that FDA drafted the documents in 2002 and has held them back pending resolution of broader legal issues about follow-on biologics. They said insulin and hGH "should be separated from the development of a larger regulatory framework because they do not raise the same scientific and regulatory issues" as other biologics. ...