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
- 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
- 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.