The opinion of the court was delivered by: Perry, District Judge.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
1. Plaintiffs filed a Complaint for Declaratory Judgment
pursuant to Title 28, United States Code, Sections 1337 and
2201 seeking to have this Court determine that their drug
Krebiozen is not a new drug within the meaning of the Federal
Food, Drug, and Cosmetic Act and is exempt from complying with
the new drug provisions of the Act by virtue of the
grandfather clause, section 107(c)(4) of the Drug Amendments
of 1962. In the alternative, the Complaint seeks to have this
Court determine that their drug Krebiozen has the status of a
new drug for which new drug applications became effective on
June 15, 1954 with respect to New Drug Application No. 9368
and on June 12, 1961 with respect to New Drug Application No.
2. The defendants answered the Complaint and alleged that
Krebiozen has always been a new drug within the meaning of the
Act, that the grandfather clause is not applicable, that no
New Drug Application has been approved or became effective,
and that Krebiozen cannot be introduced into interstate
commerce until the new drug provisions of the Act have been
3. Labeling and other promotional material establish that
Krebiozen is a drug intended to be used in the management and
treatment of malignant tumors.
4. Both parties have filed a motion for summary judgment
pursuant to Rule 56 of the Federal Rules of Civil Procedure.
5. The defendants submitted the affidavits of two medical
experts: Jesse L. Steinfeld, M.D., Surgeon General of the
United States and Deputy Assistant Secretary for Health and
Scientific Affairs, Department of Health, Education and
Welfare; and Carl G. Baker, M.D., Director of the National
Cancer Institute, National Institutes of Health.
6. The affidavits of Dr. Steinfeld and Dr. Baker establish
that there is no general recognition, among experts qualified
by scientific training and experience to evaluate the safety
and effectiveness of drugs, that Krebiozen is now or has ever
been safe or effective for the management or treatment of
7. The affidavits and other evidence submitted by plaintiffs
do not controvert the affidavits of Dr. Steinfeld and Dr.
8. The defendants also submitted the affidavit of Marion J.
Finkel, M.D., Deputy Director, Bureau of Drugs, Food and Drug
Administration, United States Department of Health, Education
and Welfare. Dr. Finkel's affidavit establishes that the Food
and Drug Administration has never approved a New Drug
Application for Krebiozen; that the new drug applications for
Krebiozen submitted to the Agency on April 15, 1954 (New Drug
Application No. 9368) and April 13, 1961 (New Drug Application
No. 12-823) were not accepted for filing because they were
incomplete and inadequate; and that the applicants were
notified of this decision within sixty days after each New
Drug Application was received by the Agency.
1. This Court has jurisdiction over the parties and subject
2. Krebiozen is now and has always been a new drug within
the meaning of the statutory definition.
3. Krebiozen is not protected by the grandfather clause,
section 107(c)(4) of the ...