Memorandum of Understanding
Between The U.S. Department of Health and Human Services
National Institutes of Health
The Pharmacology and Experimental Therapeutics Section
and The U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research

 

I. PURPOSE

The purpose of the proposed Memorandum of Understanding (MOU) is to establish a relationship between the Center for Drug Evaluation and Research, Food and Drug Administration and the Pharmacology and Experimental Therapeutics Section (PETS), LDDRD so that joint experiments can be conducted relating to drug metabolism and drug-drug interactions.

 

II. BACKGROUND

Drug metabolism and drug-drug interactions represent significant issues for the FDA's mission to ensure safe and effective drugs with adequate instructions for use. For both metabolism and interactions, studies in vitro can provide substantial information needed for drug development and regulation. Review and lab scientists in CDER have become increasingly involved in the development of the technology for testing in vitro, and its application to modern drug development and regulation.

 

The PETS directs a program of drug development for the treatment of patients with Cancer and AIDS. This program includes both intramural laboratory work and the coordination of extramurally funded work. As molecules become candidates for future testing in patients, they undergo a variety of preclinical testing in animals and in vitro systems. Currently, human metabolism of these molecules is not investigated until clinical testing is underway. Further, drug-drug interactions are studied in patients at later stages of drug development.

 

III. SUBSTANCE OF AGREEMENT

FDA scientist in the Division of Clinical Pharmacology will collaborate with the staff of PETS, LDDRD, NCI to determine metabolic pathways and potential drug-drug interactions. The technology for human liver metabolism in vitro is already in place in the FDA labs. The PETS, LDDRD, NCI will supply investigational drugs to the Division of Clinical Pharmacology for evaluation of metabolism and drug-drug interactions. Drugs under development by the PETS, LDDRD, NCI arise from a variety of sources, including the NIH Intramural Research program, NIH Extramural Grants and Contracts, nonprofit institutions, and commercial sources. Some of the compounds which will be supplied by the PETS, LDDRD, NCI, are covered by confidentiality agreements. Any information obtained or generated under this MOU will not be disclosed by FDA staff to anyone outside FDA or NCI without permission from NCI.

 

IV. PARTICIPATING PARTIES

Laboratory of Drug Discovery Research and Development
Pharmaceutical and Experimental Therapeutics Section (PETS)
National Cancer Institute — FCRDC
Bldg. 1052, Rm. 121
Frederick, MD 21702-1201

 

V. LIAISON OFFICER

For the Pharmaceutical and Experimental Therapeutics Section:

Dr. Sherman F. Stinson
LDDRD, PETS
Bldg. 1052, Rm. 121
Frederick, MD 21702-1201
(301) 846-1118
(301) 846-6177

 

VI. PERIOD OF AGREEMENT

This agreement becomes effective upon acceptance by both parties and will continue in effect indefinitely. It may be modified by mutual written consent or terminated by either party upon a 60-day advance written notice to the other party.

Approved and Accepted
for the LDDRD, PETS, DTP, DCTD, NCI
Signed by: Dr. Robert Wittes
Director, DCTD, NCI
Date: December 9, 1998

Approved and Accepted
for the Food and Drug Administration
Signed by: James Murphy
Director, OTR, CDER
Date: January 11, 1999