Hastings, Senior Circuit Judge, and Kiley and Cummings, Circuit Judges.
HASTINGS, Senior Circuit Judge.
We have before us two appeals by Tyler Pharmacal Distributors, Inc. (Tyler) from orders entered in two actions, consolidated in the district court for purposes of trial. Each action involved an article of drug known as "Pro-Forma".
Pro-Forma is represented as being safe and effective for use by women to make their breasts fuller and firmer and to restore them to feminine beauty. The active ingredient said to cause this improvement is known as Extract of Galega.
Tyler began selling Pro-Forma in 1956, using the same formula, advertising and labeling continuously through the time of trial. Tyler advertises and sells Pro-Forma through the mails, claiming the drug is safe for use.
Tyler did not seek nor obtain approval of the product as a "new drug" as required by § 505 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 355 (the Act).*fn1
A Post Office fraud complaint was issued against Tyler and a hearing thereon was held in January, 1958. The Hearing Examiner recommended that a fraud order be issued pursuant to 39 U.S.C.A. § 259. On July 14, 1958, a Departmental Decision reversed the initial decision of the Hearing Examiner for the reason "that the complainant failed to prove a fraud in fact."
On March 22, 1963, the Food and Drug Administration held a hearing at which Tyler had been charged with an alleged violation of § 301(a) of the Act with misbranding, "since the article [Pro-Forma] is of no value and will have no effect. " A record of the hearing was sent to Tyler. No further action in this misbranding matter has been taken.
On July 21, 1966, a complaint for injunction was filed in the district court by the United States of America against Tyler and two of its officers, seeking to enjoin them from shipping the drug Pro-Forma in interstate commerce in violation of 21 U.S.C.A. § 355, supra. The complaint alleged that Pro-Forma was a new drug within the meaning of § 201(p) of the Act, 21 U.S.C.A. § 321(p),*fn2 and that there was no approved new drug application (NDA) effective for the drug. The primary issue raised was whether Pro-Forma was a new drug because it was not generally recognized among qualified experts as safe and effective for its intended use.
On October 16, 1966, a pre-trial conference was held before District Judge Hubert L. Will. At that time, rather than litigate the new drug issue, Tyler offered to file a NDA for Pro-Forma within 30 days, and stated that if the NDA was denied, sale of the drug would immediately be stopped. Thereupon, Judge Will entered an order dismissing the complaint, with leave to reinstate if the NDA was not filed within 30 days.
On November 15, 1966, Tyler filed a NDA for Pro-Forma. It contained testimonials by French doctors, a report by an American physician, a laboratory report and a copy of the Post Office Departmental Decision.
Upon review of the NDA by the Food and Drug Administration, it was found inadequate to establish that Pro-Forma was safe and effective for its claimed uses. Tyler was given notice of the proposed disapproval. It requested a hearing, which was held on March 21, 1967. The Government presented testimony of three scientific witnesses who had reviewed the NDA. Tyler rested without offering testimony. The hearing was concluded and the matter was taken under advisement by the Hearing Examiner.
Eight days later, on March 29, 1967, and while the matter was under advisement by the Hearing Examiner, Tyler wrote to the Food and Drug Administration seeking to withdraw its NDA. Tentative findings and conclusions adverse to Tyler were issued by the Hearing Examiner on April 14, 1967. The request to withdraw the NDA was denied by letter dated April 25, 1967.
On April 5, 1967, prior to receiving notice of the denial of its request to withdraw its NDA, in cause No. 67 C 537, Tyler filed its complaint in the district court, pursuant to the Federal Declaratory Judgment Act, 28 U.S.C.A. § 2201, against the U.S. Department of Health, Education and Welfare; Food and Drug Administration; James Goddard, Commissioner of Food and Drugs; and James H. Guill, Jr., District Director of Food and Drug Administration. It sought a declaration that Pro-Forma be declared to be "not a new drug" within the meaning of the Act. It also sought an injunction restraining government employees in their official ...