FDA's 1999 Inspection Plan: A Shift in Focus

Strategic Insights -

The US Food and Drug Administration (FDA) will adjust its inspection priorities in 1999, with a significant decrease in the number of Bioresearch Monitoring (BiMo) and foreign inspections. The Office of Regulatory Affairs (ORA) has devised a field inspection "work plan" that outlines the projected number of inspections for various product areas. According to the plan, the number of pre-approval inspections for new and abbreviated drug applications (NDAs/ANDAs) will drop substantially, from 632 in fiscal 1996 and 1997 to 218 in 1999. Similarly, ANDA audits will decrease from 692 to 184. However, the agency will increase the number of source plasma inspections from an average of 60 per year to 272 in fiscal 1999.

Key Takeaways:

  • The FDA's 1999 inspection plan prioritizes blood and food safety over other areas, leading to a decrease in the number of BiMo and foreign inspections.
  • The agency will focus on pre-approval inspections for sponsors, monitors, and clinical investigators earlier in the NDA review process to ensure compliance with regulations.
  • The FDA will rely on sponsors and monitors to ensure clinical investigators follow regulatory guidelines, reducing the agency's burden and resources.
  • The BiMo Division will "re-engineer" its program to shift responsibility to manufacturers for keeping investigators in line, saving FDA dollars.
  • The FDA plans to increase the number of source plasma inspections from 60 to 272 in fiscal 1999.
  • The agency will have limited resources for device inspections and may not see significant increases in BiMo and foreign audits.
  • The FDA's emphasis on food and blood safety will lead to staff cuts of eight to 10 full-time employees, impacting the projected totals for drug and device inspections.
  • The Food Safety Initiative has allotted $25 million in fiscal 1999, which must be used for food safety expenses, resulting in cuts in other program areas.

Statistics:

  • 632 pre-approval inspections for NDA/ANDAs in fiscal 1996 and 1997
  • 218 pre-approval inspections for NDA/ANDAs projected in 1999
  • 692 ANDA audits in fiscal 1996 and 1997
  • 184 ANDA audits projected in 1999
  • 60 average source plasma inspections per year in fiscal 1996 and 1997
  • 272 source plasma inspections projected in fiscal 1999
  • $25 million allocated for food safety in fiscal 1999
  • Staff cuts of eight to 10 full-time employees impacting the projected totals for drug and device inspections

Sources:

  • "FDA plans for fewer inspections, more emphasis on blood and food safety" by [Unknown Author], [Unknown Publication Date]
  • "FDA to shift focus to sponsors, monitors in 1999" by [Unknown Author], [Unknown Publication Date]
  • "BiMo Division to 're-engineer' its program to shift responsibility to manufacturers" by [Unknown Author], [Unknown Publication Date]
  • "FDA's FY '99 work plan" by [Unknown Author], [Unknown Publication Date] (available from RECORD-RETRIEVE)