Edison Pharmaceutical Co., Inc. v. Food and Drug Administration, Dept. of Health, Ed. and Welfare
| Citation | 168 U.S.App.D.C. 273,513 F.2d 1063 |
| Decision Date | 02 June 1975 |
| Docket Number | No. 73-2254,73-2254 |
| Parties | EDISON PHARMACEUTICAL COMPANY, INC., Petitioner, v. FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, andCaspar W. Weinberger, Secretary, Department of Health, Education and Welfare,Respondents. |
| Court | United States Courts of Appeals. United States Court of Appeals (District of Columbia) |
Margaret A. Cotter, Atty., Dept. of Justice, with whom Thomas E. Kauper, Asst. Atty. Gen., Dept. of Justice, Alvin L. Gartlieb, Deputy Asst. Gen. Counsel, Joanne S. Sisk and Barbara Lewis Spivak, Attys., Dept. of Health, Education and Welfare, were on the brief, for respondents.
Before WILKEY, Circuit Judge, NICHOLS, * Judge, United States Court of Claims, and GASCH, ** United States District Court Judge for the District of Columbia.
Opinion for the Court filed by District Judge GASCH.
This is an appeal from a final order 1 of the Commissioner of Food and Drugs (Commissioner) that the new drug application (NDA) for Cothyrobal (NDA 16-865) submitted by petitioner Edison Pharmaceutical Company, Inc., is not approvable because of a lack of substantial evidence of its safety and effectiveness.
The Commissioner rejected petitioner's NDA without holding a hearing. He held that because petitioner had submitted no "adequate and well-controlled" studies in support of its NDA, the application was deficient on its face. Therefore there could be no genuine and substantial issue of fact outstanding which required a hearing.
Petitioner contends that it met the threshold evidentiary requirement to entitle it to a hearing on the approvability of its NDA before final action was taken by the Commissioner. It asks this Court to order the Commissioner to hold a hearing on its NDA for Cothyrobal.
The Court grants petitioner's request. We set aside the final order of the Commissioner and remand this case to the Food and Drug Administration (FDA) for a hearing on the approvability of petitioner's NDA 16-865.
The Federal Food, Drug, and Cosmetic Act of 1938, 2 as amended 3 (the Act), and the Regulations issued pursuant to the Act, 4 establish, inter alia, a product pre-clearance system under which a new drug 5 may not be marketed interstate until it has been approved by the Commissioner as "safe and effective" for its intended use. The burden is on the sponsor of the drug to demonstrate its safety and effectiveness.
Section 505 of the Act 6 and pertinent Regulations 7 set forth the procedure by which a drug manufacturer can have a new drug approved for marketing in interstate commerce.
Section 505(b) 8 requires an NDA to be submitted to FDA. This application must include reports of investigations regarding safety and effectiveness, a statement of the composition and components of the drug, a description of the methods used in and the facilities and controls used for, the manufacture, processing, and packing of such drug, samples of the drug, and specimens of labeling.
Section 505(d) 9 sets forth the grounds on which the Commissioner can refuse to approve an NDA. One of these grounds, on which Cothyrobal's NDA was determined to be deficient, 10 is that the sponsor has failed to submit "substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling."
The section further defines "substantial evidence" as evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved.
A Regulation issued by FDA 11 defines the form such investigations should take. This form includes a "plan or protocol" setting forth the objective of the study, an adequate method of selecting appropriate subjects, an explanation of the methods of observation and steps taken to minimize bias, a provision for comparison by one of four "recognized" methods of the results of treatment or diagnosis with a control, and a summary of the methods of analysis, including any appropriate statistical method. Provision is made for the waiver of any or all of these requirements, if justified, upon petition for waiver.
Three of the four "recognized" methods of comparison for testing the effectiveness of a new drug consist of comparing the results of patients treated with the new drug with other patients (1) not receiving any treatment, or (2) receiving placebos, or (3) receiving non-drug therapy. The fourth method, used in testing the effectiveness of a new drug for diseases of high and predictable mortality, involves comparing the progress of the disease in patients treated with the new drug with "prior experience historically derived from the adequately documented natural history of the disease or condition . . .."
The Regulation also states that "uncontrolled studies or partially controlled studies are not acceptable as the sole basis for the approval of claims of effectiveness." 12
On May 19, 1969, Edison submitted to FDA an NDA for its drug, Cothyrobal, 13 which is a combination of thyroid extract (levothyroxine) and vitamin B12 (cyanocobalamin) and recommended for the treatment of hypercholesterolemia, hypothyroidism, and for patients who became thyro-toxic with other types of thyroid medication. Petitioner claims that by combining thyroid extract with vitamin B12, the toxic effect of large doses of levothyroxine is overcome.
By letter dated December 1, 1969, the Commissioner denied the NDA on the ground that the information submitted in its support was inadequate under Section 505(b). 14
On December 24, 1969, Dr. Murray Israel, the inventor of Cothyrobal, and petitioner Edison Pharmaceutical Company filed an antitrust suit in the United States District Court for the District of Columbia 15 against Baxter Laboratories, Travenol Laboratories (a subsidiary of Baxter), Dr. David Kritchevsky, a consultant to FDA who was associated with Baxter, and Dr. Marion Finkel, an employee of FDA. The complaint alleged that defendants had conspired to keep Cothyrobal off the market and out of competition with Choloxin, a similar drug sold by Baxter and Travenol pursuant to an approved NDA, by influencing FDA to deny fair consideration to the NDA for Cothyrobal filed by plaintiffs. The District Court dismissed the complaint, holding that this case was exempt from the antitrust laws 16 and that plaintiffs had not exhausted their administrative remedies.
On appeal 17 this Court held in a prior opinion that the complaint, on its face, stated a cause of action, 18 and we remanded all issues to the District Court. We directed that Court to remand the question of safety and efficacy of Cothyrobal to the FDA since it has primary jurisdiction over the approval of drugs for interstate sale. But we instructed the Court to retain jurisdiction over the plaintiffs' cause of action so that
if . . . plaintiffs do not then obtain full and fair consideration by the FDA as to the safety and efficacy of their drug Cothyrobal for interstate sale, they may obtain a full hearing in the District Court on all their allegations. 19
This Court made it clear that "(t)he essential is that the plaintiffs have a full and fair presentation of all their contentions before an impartial tribunal." 20
Thereafter petitioner requested that its NDA for Cothyrobal be reactivated. It submitted no additional information in support of its application. After review by FDA personnel unconnected with the initial review of petitioner's NDA in 1969, 21 the application was again found not approvable by the Commissioner.
Edison requested an opportunity to file its NDA over protest. The effect of this was to have the NDA re-examined by still another group of FDA personnel. 22 Again it was found not approvable.
On June 28, 1973, the Commissioner published in the Federal Register 23 a Notice of Opportunity for Hearing. 24 This Notice stated the Commissioner's intention to deny petitioner's NDA, the grounds for the decision, and petitioner's opportunity for a hearing "on the question of whether such application is approvable" before the final order would be issued. The Notice warned that "a request for a hearing may not rest upon mere allegations or denials, but must set forth specific facts showing that a genuine and substantial issue of fact requires a hearing." 25 Without such showing, the Commissioner may deny an NDA without a hearing. 26
In response to this Notice a written appearance and request for a hearing was submitted by Edward "Whitey" Ford, a member of the Board of Directors of the Vascular Research Foundation on behalf of himself and over two hundred other individuals, together with letters of a testimonial nature relating to Cothyrobal from each of these individuals.
A written appearance and request for a hearing was also submitted by Edison. The request was accompanied by no new data. It consisted of medical and legal arguments as to why data previously submitted met the requirements for approval of NDA 16-865.
Upon review the Commissioner decided and stated in his final order of October 26, 1973, that the requests contained no new data which would in any way correct any of the deficiencies which had been noted in the Federal Register.
Accordingly the Commissioner concluded that there was a lack of substantial evidence that Cothyrobal has the effect it purports or is represented to have for its intended use; that the legal arguments were insubstantial; and that petitioner had failed to set forth specific facts showing that there was a genuine and substantial issue of fact in dispute requiring a hearing. This appeal followed.
Petitioner is not challenging the validity of the procedure for approving NDA's. Nor is it challenging FDA's summary judgment procedure whereby an NDA may be rejected...
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