Edison Pharmaceutical Co., Inc. v. Food and Drug Administration, 73-2254
| Citation | 168 U.S.App.D.C. 273,517 F.2d 164 |
| Decision Date | 11 August 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, and Caspar W. Weinberger, Secretary, Department of Health, Education and Welfare, Respondents. |
| Court | United States Courts of Appeals. United States Court of Appeals (District of Columbia) |
Before BAZELON, Chief Judge, and WRIGHT, McGOWAN, TAMM, LEVENTHAL, ROBINSON, MacKINNON, ROBB and WILKEY, Circuit Judges.
Respondents' suggestion for rehearing en banc having been transmitted to the full Court and no Judge having requested a vote thereon, it is
Ordered by the Court en banc that respondents' aforesaid suggestion for rehearing en banc is denied.
Statement of Circuit Judge LEVENTHAL, joined in by Chief Judge BAZELON and Circuit Judges WRIGHT, McGOWAN and ROBINSON, as to why they did not request that a vote be taken on the suggestion to En Banc.
The Commissioner of Food and Drugs refused to approve a New Drug Application (NDA) submitted by Edison Pharmaceutical Company for the drug Cothyrobal.
The FDA's final order of October 26, 1973, identified various deficiencies in Edison's NDA. The panel opinion focused on the FDA's conclusions that there was a lack of substantial evidence of Cothryobal's effectiveness and that Edison failed to submit adequate and well-controlled investigations demonstrating effectiveness. The panel opinion reverses and requires an FDA hearing.
The FDA's suggestion for rehearing en banc is concerned with how the panel opinion may be taken from what it "appears to require" and from what it "implies."
I would be similarly concerned if it did not appear that this is a unique case, to be limited to its special facts and history.
In a 1972 opinion this court was concerned with the antitrust suit brought by Edison and the drug's inventor, Dr. Murray Israel, against Baxter Laboratories and certain FDA personnel, for conspiring to keep Cothyrobal off the market by influencing FDA to deny fair consideration to the NDA. This court directed the district court to remand the question of safety and efficacy of Cothyrobal to the FDA, in view of its primary jurisdiction, but to retain jurisdiction so as to accord plaintiffs a full hearing if they did not "obtain full and fair consideration by the FDA as to the safety and efficacy of their drug Cothyrobal for interstate (Commerce.)" 1
Although at one point the current panel opinion disclaims any ruling that the prior decision required FDA to provide a hearing (see its fn. 28), at another point it decries the fact that Edison's application has been thrice denied, over during a period of some six years, "without an opportunity for hearing despite direction to the contrary from this Court." (513 F.2d at 1072).
The FDA says that subsequent to our remand it followed its usual procedures for this case after assuring that there would be no participation on this re-evaluation by any of the employees involved in the initial disapproval of Cothyrobal. On that assumption, the FDA's suggestion for reconsideration makes out a strong case for the propriety of its action. 2 But what the panel opinion is in effect holding is that in view of the history of possible implication of FDA's employees in an unlawful conspiracy against Edison, FDA should have resolved doubts in this particular case, in favor of holding a hearing on any disputed items. That ruling, while unusual, is not of such broad application as to lead us to devote the time and energy required of this court every time it gathers en banc.
There is perhaps greater difficulty with the panel's direction that the FDA hold an evidentiary hearing not only on the threshold controlled test issue, but also "hold a full evidentiary hearing on all relevant issues relating to the approvability of petitioner's application, whichever way he (the FDA Commissioner) decides the threshold issue." (513 F.2d at 1072.) The panel opinion acknowledges that this is an exceptional ruling, inserted in order to "enable this Court on review finally to bring this proceeding to a close." (513 F.2d at 1072.)
The FDA's en banc suggestion points out that there are a number of facial inadequacies in Edison's NDA, none of which are really disputed by Edison, some of which 3 are...
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- Edison Pharmaceutical Co., Inc. v. Food and Drug Administration, Dept. of Health, Ed., and Welfare
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U.S. House of Representatives v. Mnuchin
..."the time and energy required of this court every time it gathers en banc," Order Denying Rehearing En Banc, Edison Pharm. Co. v. FDA , 517 F.2d 164, 165 (D.C. Cir. 1975) (statement by Leventhal, J.), a concern that is especially pertinent given the constraints imposed by the current pandem......