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MOU 225-85-8251

Memorandum of Understanding

Between
The National Institute on Drug Abuse 

and

The Food and Drug Administration

 

FDA Compliance Policy Guide 7155e.09

 

Subject: MOU with National Institute of Drug Abuse (PHS/HHS) concerning cooperative interaction in expediting domestic scheduling of drugs of abuse

 

I. PURPOSE

This agreement describes procedures for the cooperative and timely interaction between the National Institute on Drug Abuse (NIDA) and the Food and Drug Administration (FDA) in expediting the responsibilities of the Public Health Service (PHS) for the domestic scheduling of drugs of abuse. Nothing in this memorandum is intended to compromise FDA's authority to make and forward to the Assistant Secretary for Health (ASH) all drug scheduling recommendations.

 

II. BACKGROUND

The Secretary of Health and Human Services (HHS) has delegated to the ASH the authority to make domestic drug scheduling recommendations. The Attorney General (through the Drug Enforcement Agency (DEA)) initiates on his motion, upon the request of the Secretary of HHS, or upon the petition of an interested person, proceedings for the scheduling, amendment, or repeal of a domestic scheduling classification. Scheduling proceedings are governed by the provisions of the Controlled Substances Act (CSA), 21 U.S.C. 801 et seq. Once the Attorney General initiates a scheduling proceeding, he must request from the Secretary of HHS a scientific and medical evaluation of the drug or substance at issue and a recommendation as to whether the drug or substance should be controlled domestically.

 

At the present time, HHS responds to drug scheduling requests from DEA in accordance with a procedure described in a 1970 memorandum by Merlin K. Duval, M.D., then ASH. Under that procedure, FDA has the responsibility for gathering appropriate data pertaining to the abuse potential of marketed drugs. FDA considers available data and positions from other relevant HHS agencies in preparing for the ASH the scientific and medical evaluations and recommendations. FDA then forwards the evaluations and recommendations to the ASH. The 1970 memorandum states that the director of the agency charged with drug abuse prevention should always be consulted by FDA and that his/her position on drug scheduling should be included in the evaluation and recommendations. FDA is the lead agency, however, the Drug Abuse Staff (DAS) of the Division of Neuropharmacological Drug Products (DNDP) in the Office of Drug Research and Review, which is part of the FDA's Center for Drugs and Biologics (CDB) performs the initial scientific and medical evaluation upon which a scheduling recommendation is based. The review is often performed in conjunction with FDA's review of new drug applications (NDA).

 

Both NIDA and FDA believe that a new procedure to expedite the development of domestic drug scheduling recommendations is needed. The new procedure described herein reflects FDA's role as the lead PHS agency in the process which results in the forwarding of domestic drug scheduling recommendations to the ASH. It also recognizes FDA's commitment to collaborate fully with NIDA in the development of such recommendations because of NIDA's expertise in investigating and evaluating the potential for abuse associated with drug products.

By this memorandum, FDA is formally providing NIDA the opportunity to present its views on domestic drug scheduling to FDA at an appropriately early stage in the NDA process or in other circumstances in which issues pertaining to domestic drug scheduling may arise. While NIDA's opinions will not be binding on FDA, both agencies agree to make every effort to resolve differences of opinion, should they arise, as early as possible in the course of their interactions pertaining to domestic drug scheduling.

 

III. SUBSTANCE OF AGREEMENT

The procedures to be used in the development of domestic drug scheduling recommendations will be as shown below:

A. Initial Center for Drugs and Biologics Review

1. Drug products subject to an NDA.

a. Upon receipt of an NDA for a drug product that may, under provisions of the CSA, require a scheduling recommendation to be made by the ASH, the DNDP, through the DAS, will notify NIDA of the receipt of the NDA submission.

b. Notice of DNDP organizational meeting on the NDA

(1) FDA, through the DNDP, will extend an invitation (stating the date, time, and location of the meeting) to NIDA to designate a representative to attend the introductory meeting of the NDA review team. A goal of this meeting is to determine if the drug under review should be evaluated for abuse potential.

(2) The NIDA representative shall inform the team if NIDA wishes to participate in evaluation of the drug's abuse potential.

(3) Any employee of NIDA who reviews, considers, or discusses any trade secret and confidential commercial information contained in an NDA in assessing the abuse potential of the product under consideration must first obtain any necessary FDA conflict-of-interest clearances. Clearances pertaining to confidential information are not necessary for NIDA employees who will review only information for which the NDA sponsor has waived proprietary claims (see b. (4) below). CDB will be responsible for initiating conflict of interest clearances through FDA's Policy Management Staff.

(4) In the case of drugs to be evaluated for abuse potential, FDA shall request the NDA sponsor to submit a separate drug abuse package containing relevant animal and human abuse-related data together with other information concerning the drug's potential for abuse and diversion. This request will include a request to the sponsor to waive confidentiality of the data provided so that the data can be given to NIDA for evaluation.

(5) At this meeting a determination will be made if NIDA is to receive a copy of the drug abuse data and information package to be requested from the NDA sponsor.

(6) NIDA will inform FDA if it plans to conduct an independent evaluation of the drug in question.

(7) NIDA will provide FDA by the date of the 90-day meeting (see c. below) any data it may have on the drug in question for use by the review team.

c. Notice of the DNDP 90-day NDA review team meeting.

(1) NIDA shall be provided with a written notification stating the date, time, and location of the proposed meeting. The NIDA representative shall be requested to participate in this meeting.

(2) If NIDA participates in this meeting, it indicates that NIDA has an ongoing interest in the drug under review. If NIDA elects not to participate in this meeting, then NIDA will not participate as a member of the DNDP 90-day review team for the substance under evaluation.

(3) If NIDA participates in the 90-day NDA review team meeting, FDA will provide the NIDA representative a copy of the drug abuse data and information obtained from the NDA sponsor. If no such data and information are available, FDA will provide the NIDA representative data extracted from the NDA submission which are related to a determination of the abuse potential of the drug under review, provided all employees of NIDA who will be reviewing, considering, or discussing the confidential data or information have obtained an FDA conflict-of-interest clearance, or authorization to provide these data to NIDA has been obtained from the NDA sponsor. From these data, NIDA will determine if it should perform additional studies, or confirm the NDA sponsor's data from information it has on studies already performed.

(4) NIDA will present data it has available on any studies of abuse potential either already carried out or planned for the drug under evaluation.

(5) At the 90-day meeting and any time thereafter, FDA and NIDA will exchange in a timely manner any new data concerning the abuse potential of the drug under evaluation that may become available. As discussed above, appropriate clearances must be secured before data may be shared with NIDA.

2. Drug products not subject to a pending NDA: When a domestic drug scheduling question arises other than in connection with FDA review of a pending NDA, FDA will inform NIDA of the scheduling issue and will invite NIDA to participate in the evaluation process.

3. In all situations covered by Part A of this agreement, FDA will make available to NIDA a copy of its proposed draft scheduling recommendation.

 

B. Consideration of Draft Scheduling Recommendations by the FDA Drug Abuse Advisory Committee (DAAC)                                         

1. The Executive Secretary of DAAC will notify NIDA when a scheduling matter has been placed on a DAAC meeting agenda and will provide NIDA a copy of the agenda as soon as it is available.

2. Data provided to DAAC to assist in its deliberation on a drug scheduling matter will be made available to the NIDA representative at the same time they are made available to the DAAC members. The NIDA representative shall have secured any necessary FDA conflict-of-interest clearance in advance of receipt of these data or authorization to release the data will be secured from the NDA sponsor.

3. NIDA will provide DAS any comments or specific data it has regarding an agenda item as far in advance of the meeting as possible so that NIDA's comments and data can be sent to the DAAC members for review prior to the meeting.

4. NIDA may indicate its desire to make a formal presentation to DAAC on any drug scheduling item that is part of the scheduled agenda for a DAAC meeting. Such a presentation would normally consist of at least one of the following:

a. A response to a general question concerning drug scheduling, (DAS should have received a copy o the data NIDA will present—see B.3. above.)

b. Results of an independent evaluation conducted by NIDA. The presentation should emphasize NIDA's additional data or different points of view from those of FDA. (Data should be provided in advance to DAS –see B.3. above.)

c. A statement that NIDA has determined to present no data.

 

C. Review of Final Draft Scheduling Recommendations

1. After the DAAC meeting, a proposed final scheduling recommendation will be drafted by and circulated within CDB. A copy of the draft recommendation will promptly be provided to NIDA for comment.

2. If the CDB draft scheduling recommendation is substantially revised by FDA, a copy of the revised document will be transmitted to NIDA for further comment.

3. If NID does not concur in the final recommendation before it is submitted to the FDA Commissioner for signature, NIDA should specify its nonconcurrence to the FDA Commissioner in writing. The data upon which NIDA's position is based should be included in this document.

4. If disagreement between the agencies can not be resolved, the NIDA dissent will be forwarded to the ASH concurrently with FDA's scheduling recommendations.

 

IV. NAME AND ADDRESS OF PARTICIPATING PARTIES

A. Food and Drug Administration
Public Health Service
Department of Health and Human Services
5600 Fishers Lane
Rockville, Maryland 20857

 

B. National Institute on Drug Abuse
Public Health Service
Department of Health and Human Services
5600 Fishers Lane
Rockville, Maryland 20857

 

V. LIAISON OFFICERS

A. For Food and Drug Administration:
Associate Commissioner for Health Affairs
(currently Stuart L. Nightingale, M.D.)
301-443-6143

 

B. For National Institute on Drug Abuse:
Associate Director for Medical and
International Affaris
(currently James R. Cooper, M.D.)
301-443-4877

 

VI. PERIOD OF AGREEMENT

This agreement becomes effective upon acceptance by both parties. It may be modified by mutual consent or terminated by either party upon the giving of a 60-day written notice.

Approved and Accepted
for the National Institute on Drug Abuse

Signed by: William Pollin, Director

Date: December 11, 1984

Approved and Accepted
for the Food and Drug Administration

Signed by: Mark Novitch

Date: November 13, 1984