Merritt Corporation v. Folsom, Civ. No. 338-58.

• Citation: 165 F. Supp. 418
• Decision Date: 21 May 1958
• Docket Number: Civ. No. 338-58.
• Parties: The MERRITT CORPORATION, Plaintiff, v. Marion B. FOLSOM, Secretary of U. S. Department of Health, Education, and Welfare, George P. Larrick, Commissioner, Food and Drug Administration, Department of Health, Education, and Welfare, William P. Rogers, Attorney General of the United States, Defendants.
• Court: U.S. District Court — District of Columbia

165 F. Supp. 418

The MERRITT CORPORATION, Plaintiff, v. Marion B. FOLSOM, Secretary of U. S. Department of Health, Education, and Welfare, George P. Larrick, Commissioner, Food and Drug Administration, Department of Health, Education, and Welfare, William P. Rogers, Attorney General of the United States, Defendants.

Civ. No. 338-58.

United States District Court District of Columbia.

May 21, 1958.

COPYRIGHT MATERIAL OMITTED

Oliver Gasch, U. S. Atty., Robert J. Asman, Asst. U. S. Atty., William W. Goodrich, Asst. Gen. Counsel, Dept. of Health, Education and Welfare, Washington, D. C., for U. S.

Harry M. Edelstein, Washington, D. C., Milton A. Bass, New York City, for plaintiff.

CURRAN, District Judge.

Findings of Fact

1. On February 11, 1958, the plaintiff, Merritt Corp., filed a complaint for injunction seeking to restrain the defendant government officials from instituting further seizure actions against plaintiff's drug product, "Clarimycin Anti-Biotic Acne Lotion."

2. Pursuant to Section 304 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C.A. § 334 the defendants have caused to be instituted six seizure actions in various parts of the country against "Clarimycin." There was no Section 304 determination of probable cause.

3. Each of the seizure actions instituted allege that "Clarimycin" is a new drug which may not be introduced into interstate commerce under the provisions of Section 505(a) 21 U.S.C.A. § 355(a), since an application filed pursuant to Section 505(b) 21 U.S.C.A. § 355(b) is not effective with respect to the drug.

4. The active ingredient of "Clarimycin" is the antibiotic neomycin sulfate.

5. From 1949 to 1955 all neomycin sulfate preparations were deemed to be new drugs requiring the filing of an application pursuant to Section 505 21 U.S.C.A. § 355 before the drug could be marketed in interstate commerce.

6. In 1955 certain types of neomycin sulfate preparations were declared by the United States Food and Drug Administration no longer to be new drugs when labeled for use only for the prevention of infections in the temporary self-limiting conditions of minor cuts, burns and abrasions.

7. Plaintiff markets its neomycin sulfate lotion preparation in interstate commerce for sale to the layman with labeling recommending use of the product for the treatment of acne.

8. Acne vulgaris is a chronic, recurring disease condition of the skin which may last for years and which therefore requires treatment for a prolonged period of time.

9. When viewed in the light most favorable to it, plaintiff's medical affidavits assert that topical neomycin sulfate is generally recognized by experts as safe in the treatment of acne, even when used over prolonged periods of time.

10. Defendant's medical affidavits assert that topical neomycin sulfate is not generally recognized as safe by experts in the treatment of acne, because it has been shown to produce sensitization and cross-sensitization to streptomycin, an antibiotic valuable in the treatment of serious disease conditions. In addition, that use of neomycin sulfate for the treatment of acne is a new use for neomycin sulfate both because it has not been generally used for such a disease before and also because prolonged administration, which is required in an acne treatment, is a new method of utilizing the drug.

Conclusions of Law

The Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 334, imposes no limitations upon the number of seizure actions which may be instituted under a "New Drug" charge, i.e. that the drug is one which may not, under the provisions of Section 505 21 U.S.C.A. § 355 be introduced into interstate commerce.

2. Multiple seizures based on a "New Drug" charge may be instituted without the making of any probable cause determination under Section 304 21 U.S.C.A. § 334.

3. The newness of a drug, within the meaning of the Federal Food, Drug, and Cosmetic Act may arise by reason of, among others, a new or different recommended use for the drug, or a new or different duration of administration, even though the same drug may not be a new drug when used in another disease or other duration of...