understanding and applying “the drug law and regulations [require] technical knowledge that is not part of this court’s working kit”
How later courts described this case
- understanding and applying “the drug law and regulations [require] technical knowledge that is not part of this court’s working kit”
- “The 1962 legislation contemplated that withdrawals would commence two years after the Act’s effective date.”
- rejecting argument that controlled tests are impossible for drug designed to relieve pain
Written by the judges who cited it.
The opinion
ON PETITIONER’S PETITION FOR REHEARING
ORDER
On consideration of petitioner’s petition for rehearing it is
Ordered by the Court that the aforesaid petition is denied.
Statement of Circuit Judge LEVEN-THAL as to why he voted to deny rehearing.
I have decided not to vote for rehearing, nor to ask the court to vote on the suggestion of rehearing en banc, primarily because the court is heavily burdened at the present time, and because it is my judgment that the combined effect of my dissent and of Judge Wright’s caveat to the majority opinion will result in a different course at the administrative level in the future. I am fortified in this judgment by a reading of regulations issued March 13, 1974, 1 in which the FDA sets forth a modification of its summary judgment procedures in contemplation of compliance with our Hess & Clark opinion. 2 This does not help the appellant, who is governed by a disposition that I think is a mistake; but the appellant can perhaps obtain some relief by submission to FDA of a *794 new set of studies. More importantly, there is a difference between a mistake in an individual case and a mistake that will affect ongoing policy, and it is my perhaps optimistic judgment that the net result of this case will be confined to the facts presented. I should like to give notice, however, that the requirements of fair procedure voiced in my dissent are still a part of my working kit of judicial review, and that if my present estimate does prove to be optimistic, I shall not hesitate to call upon the court for a full dress reconsideration.
. 39 Fed.Reg. 9750 (Mar. 13, 1974).
. Hess & Clark, et al. v. FDA, 161 U.S.App.D.C. 395 , 495 F.2d 975 (1974).