FDA仿制药申报者付费法案.pdfVIP

Agenda • Process and Access • Challenges and Success of Generics • Outlines of the Act • Legislative Language • Goals Letter • Next Steps • Questions and Answers Process and Access Generic Industry Large Fragmented • Made up of both final dosage form (FDF) and active pharmaceutical ingredient (API) manufacturers • Thousands of firms spread worldwide • In virtually every continent and country • Large and small Access To All Through Multiple Vehicles • Extensive outreach • FDF and API trade associations at table – Generic Pharmaceutical Association (GPhA,) European Fine Chemicals Group (EFCG,) and the Society of Chemical Manufacturers and Affiliates’ Bulk Pharmaceuticals Task Force (SOCMA’s BPTF) • Members worldwide – 16 all-day negotiation sessions using a highly transparent process • Negotiation summaries on public Web site • Open docket throughout – FDA-2010-N-0381 – Open Sept. 17, 2010 - Jan 6, 2012 • Multiple open public stakeholder meetings – 6 public meetings stakeholder updates, starting Sept. 17, 2010 Environment Generics Success = Unprecedented Regulatory Challenge • $931 billion in savings (2001-2010) has resulted in continued success and growth • While program funding has remained relatively flat • Generics industry success has come to represent an unprecedented regulatory challenge in terms of – Size – Scope – Geography g s a r u w e c i r 1 h r t o h 1 o t D s g 0 n i i 2 a h h w e N 1