UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

DECLARATION OF DANIEL A. SPYKER, Ph.D., M.D.

I, Dr. Daniel A. Spyker, do hereby declare the following:

   1.  I am a Medical Officer in the Pilot Drug Evaluation Staff, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA).  I have held this position since August 1990.

   2.  In my position as Medical Officer, I am engaged fulltime in the evaluation of clinical drug trials, proposed and completed, in support of investigational new drug applications (INDs) and new drug applications submitted to the FDA under the Federal Food, Drug, and Cosmetic Act (the Act).  Since October 1990, I have been responsible for the review and follow-up of INDs relating to marijuana, including a number of single-patient INDs from physicians requesting therapeutic marijuana for their patients.

   3.  A single-patient IND for marijuana, an unapproved new drug under the Act, allows a physician to receive and dispense the drug as an investigational drug for use in one specific patient.  Because marijuana is not a drug approved by the FDA, distribution of marijuana outside the IND process is in violation of the Act.

   4.  While FDA processes and allows single-patient INDs for investigational drugs to proceed, FDA does not supply the drugs.  In the case of single-patient INDs for marijuana, the marijuana is provided by the National Institute on Drug Abuse, Public Health Service, Department of Health and Human Services, pursuant to its authority under the Public Health Service Act.  Before the National Institute on Drug Abuse can supply marijuana to the sponsoring physician for a single-patient IND, because the drug is regulated under the Controlled Substances Act, the physician must apply to and receive approval from the Drug Enforcement Administration, the Department of Justice, to receive and dispense the marijuana.  When the Drug Enforcement Administration issues a registration for the physician to receive the marijuana, it provides the order form which must be presented to the National Institute on Drug Abuse for shipment of the marijuana.

   5.  When a single-patient IND for marijuana is received by the Center for Drug Evaluation and Research, it is forwarded to the Pilot Drug Evaluation Staff for review.  The IND is assigned to a consumer safety officer who distributes copies to the reviewing chemist, pharmacologist, and medical officer.  These reviewers decide whether it is safe for the study proposed in the IND to proceed.

   6.  The Center for Drug Evaluation and Research received a single-patient IND for marijuana for Ladd Huffman on January 2, 1991.  The IND was submitted by Patricia J. Harrison, M.D.  The IND was received by the Pilot Drug Evaluation Staff on January 7, 1991.  The consumer safety officer distributed the IND to the reviewers.  The pharmacology review was completed on January 10, 1991, and it determined that it was safe for the IND to proceed.  The chemistry review was completed on January 11, 1991, and it determined that it was safe for the IND to proceed.

   7.  I called the sponsoring physician, Dr. Harrison, on January 11, 1991, to discuss the requirements for the IND and to request the submission of additional information.

   8.  I completed the medical review of the IND for Ladd Huffman on January 16, 1991, and determined that it was safe for the IND to proceed.  On January 25, 1991, I received the information I had requested from Dr. Harrison.

   9.  On March 8, 1991, I issued a letter to Dr. Harrison advising her that the IND for Ladd Huffman could proceed.

   10.  In June 1991, the Pilot Drug Evaluation Staff was advised that the Assistant Secretary for Health, Department of Health and Human Services, had decided to consider whether the National Institute on Drug Abuse would continue to supply marijuana for single-patient INDs.

   11.  In March 1992, the Pilot Drug Evaluation Staff was advised that the Secretary of the Department of Health and Human Services had made a decision that the National Institute on Drug Abuse would not provide marijuana for single-patient INDs except to those patients who were receiving marijuana at the time.  This group receiving marijuana included patients whose INDs FDA has already reviewed and allowed to proceed, whose physicians had received approval to receive the marijuana from the Drug Enforcement Administration and for whom the National Institute on Drug Abuse had shipped marijuana upon receipt of the Drug Enforcement Administration order form submitted by the physicians.

   12.  As I understand it, the March 1992 decision of the Secretary of Health and Human Services not to provide marijuana to additional single patient INDs was based on a number of considerations including the health concerns of providing patients with potentially harmful substances, and the fact that existing medical evidence does not support additional research on smoked marijuana to treat disease in single patient studies.  For those patients who had already received marijuana, marijuana would continue to be supplied while their physicians, with assistance from the Department of Health and Human Services, explored alternative therapies.  Through attrition among this patient group, the Department of Health and Human Services would eventually achieve its ultimate goal of not supplying marijuana for any patients under single-patient INDs.

   13.  As I understand from the National Institute on Drug Abuse, shipments began in August 1991 for the last person to receive marijuana under a single-patient IND.

   14.  As I understand from the Drug Enforcement Administration, that agency received an application from Dr. Harrison to receive and dispense marijuana for Ladd Huffman on August 19, 1991, but no registration to receive marijuana was issued.  Since Dr. Harrison had not received approval to receive and dispense marijuana for Ladd Huffman from the Drug Enforcement Administration, the National Institute on Drug Abuse had not shipped any marijuana for Ladd Huffman.  Therefore, under the March 1992 decision of the Secretary, the National Institute on Drug Abuse would not supply marijuana for Ladd Huffman's single-patient IND.

   15.  There were 27 additional single-patient INDs that FDA had allowed to proceed which had not received marijuana.  Under the Secretary's March 1992 decision, marijuana would not be supplied for these INDs by the National Institute on Drug Abuse.

   16.  In March 1992, as a result of the Secretary's decision, I contacted the sponsoring physicians of the INDs for Ladd Huffman and other patients who were not already receiving marijuana to advise them that the National Institute on Drug Abuse would not supply marijuana for their single-patient INDs.  I also advised the sponsoring physicians of other treatment options for their patients' conditions and the availability of referrals to experts at the National Institutes of Health, Public Health Service, Department of Health and Human Services.  The single-patient INDs for these individuals were cancelled.

   17.  FDA cannot disclose information regarding patients receiving marijuana under single-patient INDs without such patients' consent.

   Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury that, to the best of my knowledge and belief, the foregoing is true and correct.

   Executed on: June 16, 1993, at Rockville, MD.

Daniel A. Spyker, PhD, M.D.
Medical Officer
Pilot Drug Evaluation Staff
Center for Drug Evaluation
and Research
United States Food and Drug
Administration