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SUBPART D PRESENTATION

SUBPART D PRESENTATION. Inaugural meeting of the Pediatric Ethics Subcommittee (PES) of the Pediatric Advisory Committee (PAC); part of the inaugural meeting of the PAC Pediatric Ethics Subcommittee Address Subpart D referrals

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SUBPART D PRESENTATION

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  1. SUBPART D PRESENTATION • Inaugural meeting of the Pediatric Ethics Subcommittee (PES) of the Pediatric Advisory Committee (PAC); part of the inaugural meeting of the PAC • Pediatric Ethics Subcommittee • Address Subpart D referrals • Address ethical issues that impact on research affecting the pediatric population • First open meeting with OHRP regarding a joint referral under 45 CFR 46.406 and 21 CFR 50.54

  2. FDA involvement with Subpart D regulations • Advisory Committee Recommendations November 15, 1999 • Children’s Health Act of 2000 • Interim Final Rule April 24, 2001

  3. 1999 Advisory Committee Recommendations • FDA should adopt the principles described in 45 CFR Part 46, Subpart D: Additional Safeguards for Children in Clinical Investigations • Recommendation endorsed by AAP and PhARMA

  4. Children’s Health Act of 2000 • Requires that all HHS-funded, supported, or regulated research comply with these additional protections for children

  5. Interim Final Rule (4/24/01) • Adoption of Subpart D regulations by FDA

  6. Pediatric Advisory Committee • Best Pharmaceuticals for Children Act, 2001 • Pediatric Research Equity Act, 2003

  7. 45 CFR 46.407, 21 CFR 50.54 • If an IRB does not believe it can approve the research under 46.404/50.51, 46.405/50.52, or 46.406/50.53, the clinical investigation may proceed only if: • The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children --and--

  8. 45 CFR 46.407, 21 CFR 50.54 (cont.) • The Secretary/Commissioner of FDA, after consultation with a panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and following an opportunity for public review, and comment determines either: • The clinical investigation in fact satisfies 46.404/50.51 or 46.405/50.52 or 46.406/50.53, or • The following three conditions are met: 1. The clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children 2. The clinical investigation will be conducted in accordance with sound ethical principles 3. Adequate provisions are made for soliciting assent and parental permission

  9. Possible Recommendations the PES Can Make to the PAC • Recommend allowing the protocol to proceed because it satisfies 46.404/50.51, 46.405/50.52, or 46.406/50.53 • Recommend allowing the protocol to proceed, with modifications, because it satisfies 46.404/50.51, 46.405/50.52, or 46.406/50.53 • Recommend allowing the protocol to proceed because it satisfies 46.407/50.54 • Recommend that the protocol not be allowed to proceed, providing specific reasons

  10. TRANSPARENCY PUBLIC INPUT EFFICIENCY TIMELINESS CLARITY CONSISTENCY EXPERT INPUT (ethical, scientific, legal, medical, educational) HARMONIZATION WITH OHRP (unified, comprehensive federal process) GOALS

  11. HHS and FDA Regulations regarding allowing a protocol to proceed under 21 CFR 50.51 or 45 CFR 46.404 .52 .405 .53 .406 .54 .407 are comparable. The differences occur after the PAC makes its decision.

  12. After today's’ meeting of the PES? • Chair summarizes PES’ review and gives PES’ recommendations to PAC • Recommendation of PAC submitted to FDA Commissioner • OHRP submits finding of Commissioner to HHS Secretary • Decision by HHS Secretary

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