Rapid Response Team

1. Rapid Response Team Nakissa Sadrieh, Ph.D. Associate Director for Research Policy and Implementation, OPS

2. Overview of the Rapid Response Team (RRT) • The RRT is a research-based mechanism: • To provide research support to review divisions and ultimately drug approvals. • To respond to literature reports of drug inefficacy or toxicity. • To evaluate suspected causes of therapeutic inequivalence. • To provide data for counterterrorism initiatives.

3. Background on Rapid Response Team (RRT) • Created in November 2000 • Function: to provide timely and specific research support (laboratory-based or literature-based) for designated regulatory issues that require further Agency study. • Goal: to provide review divisions with sound scientific data which may be used in regulatory process.

4. Composition of RRT • Group of multidisciplinary scientists from • OTR • ONDC • OCPB • OGD • Initially part of OTR, however now part of OPS immediate office

5. RRT projects are: • High priority • Have short turnaround time (maximum 6 months) • Expected to have direct regulatory impact: • support reviewer recommendations (OND and OGD) • support labeling changes • support for advisory committee issues

6. Examples of past projects • Palatability of doxycycline and potassium iodide tablets in human subjects to identify dosing regimens that would be appropriate for pediatric populations in the event of a bioterrorism incident. • Permeability study of commercially available gloves to a lotion and shampoo used for treatment of lice.

7. Examples of past projects (cont’d) • Determination of dissolution properties of select drugs. • Determination of BCS classification of select drugs. • Determination of neurotoxicity of ketamine in juvenile animal models.

8. Resources • OTR laboratories: • Laboratory of Clinical Pharmacology (LCP) • Division of Pharmaceutical Analysis (DPA in Saint Louis) • Division of Product Quality Research (DPQR) • Division of Applied Pharmacology Research (DAPR) • Contracts (Univ. of Tennessee, USHUS)

9. Ongoing projects • Palatability study of ciprofloxacin tablets in human subjects, to identify appropriate dosing regimens for pediatric populations in the event of a bioterrorism incident. • Research support for the Therapeutic Inequivalence Action Coordinating Committee (TIACC).

10. Ongoing studies (cont’d) • Data mining projects with the Office of Drug Safety (ODS) to characterize adverse event profiles for generic drugs, as compared to innovators. • Providing laboratory support for select RSR projects.

11. Accomplishments of RRT • Generated data for publication on the FDA website, of “Home Preparation Procedure for Emergency Administration of Potassium Iodide Tablets to Infants and Small Children” (http://www.fda.gov/cder/drugprepare/kiprep.htm) • Generated data to update drug label information.

12. Future directions • To provide sound scientific data which may contribute to policy decisions by regulators. • Identify new areas of regulatory research which might help policy development. • Collaborate with scientists outside of FDA to identify new technologies which might be incorporated in drug development.