Results Wire: US FDA Advisory Committee Reviews Sedation in Pediatric Clinical Trials and Drugs Required for Review Under BPCA/PREA/PMDSIA – MAR 23-24, 2015 (PEDAC)
On Monday, March 23, 2015, the Pediatric Ethics Subcommittee to the Pediatric Advisory Committee (PEDAC) discussed the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations, at 21 CFR 50 subpart D. A slight majority of the Subcommittee, 9 of 16 members, voted that there are no approaches to procedural sedation that would present no more than a minor increase over minimal risk.
On Tuesday, March 24, 2015, the PEDAC discussed pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA, Pub. L. 107-109), the Pediatric Research Equity Act (PREA, Pub. L. 108-155), and the Pediatric Medical Device Safety and Improvement Act of 2007 (PMDSIA). The PEDAC unanimously agreed with the FDA’s proposal to continue routine pharmacovigilance for the following products: QUILLIVANT XR (methylphenidate hydrochloride), LUNESTA (eszopiclone), RISPERDAL (risperidone), OXTELLAR XR (oxcarbazepine), REVATIO (sildenafil), ADVAIR HFA (fluticasone propionate/salmeterol xinafoate), DYMISTA (azelastine hydrochloride/fluticasone propionate), QNASL (beclomethasone dipropionate), VENOFER (iron sucrose), INVIRASE (saquinavir), ALTABAX Ointment (retapamulin), FluMist QUADRIVALENT (influenza vaccine live, intranasal), FLUARIX QUADRIVALENT (influenza virus vaccine), and LIPOSORBER LA-15 System. All but one of the Committee members agreed with the FDA’s proposal to continue routine pharmacovigilance for CYMBALTA (duloxetine hydrochloride). All but two of the Committee members with the FDA’s proposal to continue routine pharmacovigilance for the Medtronic ACTIVA DYSTONIA THERAPY; those two members abstained.