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U.S. Department of Health and Human Services

Combination Products

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Meetings, Conferences, & Workshops

American Academy of Orthopaedic Surgeons by Barbara D. Boyan, Ph.D.

Slide 1 - FDA Regulation of Combination Products

Barbara D. Boyan, Ph.D.
American Academy of Orthopaedic Surgeons
Professor and Deputy Director for Research for the Georgia Tech/Emory Center for the Engineering of Living Tissues
November 25, 2002

Slide 2 -

  • AAOS has a commitment to quality care and patient safety initiatives.
  • AAOS suggestions for the regulation of combination products.

Slide 3 - Decrease regulatory burden

  • Combination products provide unique challenges to FDA- under current scheme it will be difficult to get products to market.
  • Large start up capital
  • Tissue-engineered products have a smaller potential market (except cartilage subs.)
  • 2 TE companies filed for bankruptcy- regulatory problems
  • Coordinate with CMS

Slide 4 - Team Approach

  • Both in-house and 3rd party reviews
  • Multidisciplinary Coordination
    • Materials Scientist
    • Biologist
    • Clinician
    • Engineer
  • Odd number of reviewers
  • Sponsor should have the opportunity to provide additional information with the FDA Homework packet

Slide 5 - Focus more on safety than effectiveness

Effectiveness could take 10-20 years in orthopaedic products.
Single and consistent regulatory pathway over time.

For mode of action in bone products-

Slide 6 - Osteogenesis

  • Cellular elements, either from the host or from the TE product, which survive transplantation and synthesize new bone at recipient site.

Slide 7 - Osteoinduction

New bone realized through the active recruitment of host mesenchymal stem cells from the surrounding tissue, which differentiate into bone-forming osteoblasts or form bone by endochondral ossification. Facilitated by presence of growth factors, principally BMPs.

Slide 8 - Osteoconduction

The facilitation of blood-vessel incursion and new-bone formation into a defined trellis structure.

Slide 9 - Use foresight in preparing for global harmonization

  • CBER should work with the TEMPS subcommittees of ASTM on tissue standards
  • Several standards have already been finalized
  • Encourage global harmonization efforts

Slide 10 - Create Advisory Panel

  • Consider the establishment of an FDA Advisory Panel with biological and device expertise.
  • FDA biologist and engineer reviewers should work side-by-side during the review process.
  • The review should consider method of use as well as primary mode of action.
  • TEMPs are not the same as drugs or biologics.

Slide 11 - Adverse Event Reporting

  • Patient Safety movement
  • AAOS supports legislation introduced into the 106th & 107th Congress that will encourage a nonpunitive approach for reporting that ensures appropriate confidentiality & peer review protections
  • AAOS encourages the finalization of the Donor Suitability & Good Tissue Practice regulations

Slide 12 - Adverse Event Reporting (continued)

  • AAOS suggests that FDA work with experienced clinicians to define the term “adverse event” for procedures.
  • FDA’s interpretations of adverse events are too broad.
  • For combination products, users will not readily understand the regulatory class- coordinate reporting within FDA.
  • FDA mechanism is not interactive.

Slide 13 - General Principles

  • Consistency
  • Predictability
  • FDA Accountability
  • Don’t change rules midstream- very difficult for companies to have the regulatory status changed.
  • One application

Slide 14 -

AAOS looks forward to working with the FDA on bringing new products to market and ensuring patient safety.

Slide 15 -

AAOS appreciates the opportunity to participate in this open public meeting.

Thank You