FDA to Increase Inspections of Biologics Makers

Strategic Insights -

The US Food and Drug Administration (FDA) is stepping up its inspections of makers of licensed biologics, including biotech drugs, and pharmaceutical company laboratories in the coming year. According to Dr. Rebecca Devine, associate director for policy at the Center for Biologics, the agency's "Team Biologics" audits will reach 90 for this fiscal year, up from 35 team inspections conducted so far this year, and 34 for all of 1998.

Devine noted that 11 of the audits involved makers of therapeutics, 14 covered medical devices, seven addressed plasma-fractionated products, and three were for allergenics. The FDA has issued six warning letters as a result of these inspections, five of which went to companies making in vitro diagnostics and one to a blood fractionation firm. Plasma derivative audits have also increased, with 20 companies inspected in 1999 compared to 7 in 1998.

Key Takeaways:

  • The FDA's "Team Biologics" audits will reach 90 for this fiscal year, a significant increase from 35 team inspections conducted so far this year.
  • Of the 35 team inspections conducted so far this year, 11 involved makers of therapeutics, 14 covered medical devices, seven addressed plasma-fractionated products, and three were for allergenics.
  • The FDA has issued six warning letters as a result of the inspections, five of which went to companies making in vitro diagnostics and one to a blood fractionation firm.
  • Plasma derivative audits have increased significantly, with 20 companies inspected in 1999 compared to 7 in 1998.
  • The FDA will place a greater focus on examining company laboratories, particularly for drugs, and will scrutinize pharmaceutical company laboratories more carefully.
  • FDA labs will rely on state-of-the-art instruments, including PCR, and will probe for impurities in active pharmaceutical ingredients.

Statistics:

  • 90 "Team Biologics" audits for this fiscal year
  • 35 team inspections conducted so far this year
  • 34 team inspections conducted in 1998
  • 20 plasma derivative audits in 1999
  • 7 plasma derivative audits in 1998
  • 6 warning letters issued by the FDA as a result of the inspections
  • 5 warning letters issued to companies making in vitro diagnostics
  • 1 warning letter issued to a blood fractionation firm
  • 67% of warning letters contained laboratory controls issues in 1997

Sources:

  • Dr. Rebecca Devine, associate director for policy at the Center for Biologics
  • Dr. Dennis Guilfoyle, Ph.D., of the Northeast Regional Lab, New York district
  • Brenda Holman, New York District Office Director
  • Al King, director of the drug chemistry branch, New York district
  • David Elder, a compliance officer in the agency's New England district
  • FDA Modernization Act of 1997
  • The Guilfoyle/Holman presentations are $2 plus retrieval. Doc. 108649M