# Presentation: 352921

## Rapid Response Team

- Nakissa Sadrieh, Ph.D.
- Associate Director for Research Policy and Implementation,
- OPS

## 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.

## 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.

## Composition of RRT

- Group of multidisciplinary scientists from
- OTR
- ONDC
- OCPB
- OGD
- Initially part of OTR, however now part of  OPS immediate office

## 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

## 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.

## 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.

## 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)

## 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).

## 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.

## 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.

## 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.