Source: https://law.justia.com/cases/federal/appellate-courts/F2/608/1376/249080/
Timestamp: 2020-08-10 12:18:50
Document Index: 539018031

Matched Legal Cases: ['§ 514', '§ 514', '§ 512', '§ 360', '§ 306', '§ 512', '§ 512', '§ 360', '§ 512']

Rhodia, Inc., Hess & Clark Division, Petitioner, v. Food and Drug Administration, Respondent, 608 F.2d 1376 (D.C. Cir. 1979) :: Justia
Justia › US Law › Case Law › Federal Courts › Courts of Appeals › D.C. Circuit › 1979 › Rhodia, Inc., Hess & Clark Division, Petitioner, v. Food and Drug Administration, Respondent
Rhodia, Inc., Hess & Clark Division, Petitioner, v. Food and Drug Administration, Respondent, 608 F.2d 1376 (D.C. Cir. 1979)
US Court of Appeals for the District of Columbia Circuit - 608 F.2d 1376 (D.C. Cir. 1979) Argued Jan. 12, 1979. Decided Sept. 18, 1979
There is no indication that the FDA has previously considered changes in a NADA that will increase available quantities of a new animal drug to bear on the safety of the drug. Indeed, the contrary appears to be the case. The FDA's own regulations affirmatively exclude from the approval requirement certain NADA changes that appear to possess a potential for increasing quantities on the market similar to, or even greater than, that of changes in approved suppliers. Changes in equipment, including the enlargement of plant capacity that do not alter the method of manufacture, and changes in commercial batch size, are permitted without the submission or approval of a supplemental NADA. 21 C.F.R. § 514.8(a) (5) (iii), (iv) (1978). An applicant may add new distributors of an approved drug automatically upon submission of a supplemental NADA for which no approval is required. Id., § 514.8(a) (6). Further, there is no check on the ability of a supplier of an applicant's bulk drug to increase its manufacturing capacity (and thus the quantity of drug available to the applicant).
On the merits of the issue, I suggest that the FDA construction is reasonable,3 and consistent with the language of § 512(e) (1) (E) of the Food, Drug and Cosmetic Act (the Act), which provides the primary source of FDA authority to approve supplemental NADA's: "The supplemental application shall be treated in the same manner as the original application." 21 U.S.C. § 360b(e) (1) (E) (1976).
The Act is to be construed liberally to effectuate its overriding purpose to protect the public health. United States v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784, 798, 89 S. Ct. 1410, 22 L. Ed. 2d 726 (1969). The FDA's broad mandate to safeguard the public health thus affords it the flexibility to shape its administrative actions when it has reason to doubt the safety of a new animal drug. For example, it may have proper grounds for denial of a supplement because of doubts even though these doubts may not amount to the "new evidence" required for withdrawal of approval. Similarly, the law permits the view that concerns may exist that justify the FDA in declining to lend its approval to a strengthening of the NADA, even though the FDA is not yet warranted in terminating the NADA.
Section 512(d) (1) (H) of the Act, 21 U.S.C. § 306b(d) (1) (H) requires the Secretary to refuse to approve a NADA if the new animal drug induces cancer in man or animal, unless the Secretary finds that the drug will not adversely affect the animals for which it is intended and that no residues of the drug can be found in any food derived from the animals. The Secretary is also required to withdraw approval of a NADA if the standards of § 512(d) (1) (H) are met. Id., § 512(e) (1) (B), 21 U.S.C. § 360b(e) (1) (B) (1976)
See, e. g., United States v. Ammidown, 162 U.S.App.D.C. 28, 38, 497 F.2d 615, 625 (1973); United States v. Poole, 161 U.S.App.D.C. 289, 297, 495 F.2d 115, 123 (1974); Bellei v. Rusk, 296 F. Supp. 1247, 1252 (D.D.C. 1969) (three-judge court, Rev'd, 401 U.S. 815, 91 S. Ct. 1060, 28 L. Ed. 2d 499 (1971)
This is appropriate to the conception of the agency/court "partnership", Cf. Greater Boston Television Corp. v. FCC, 143 U.S.App.D.C. 383, 393-94, 444 F.2d 841, 851-52 (1970), Cert. denied, 403 U.S. 923, 92 S. Ct. 2233, 29 L. Ed. 2d 701 (1971). Certainly a court should not betoken disinterest in the avoidance of unnecessary expenditures of the scarce resources of agencies and affected interests
Because the FDA is interpreting a statute that Congress directs it to enforce, its interpretation should be sustained if it has a "reasonable basis in law." See Udall v. Tallman, 380 U.S. 1, 16, 85 S. Ct. 792, 13 L. Ed. 2d 616 (1964), Reh. denied, 380 U.S. 989 (1965). See also Train v. Natural Resources Defense Council, 421 U.S. 60, 87, 95 S. Ct. 1470, 43 L. Ed. 2d 731 (1975) (interpretation by EPA of Clean Air Act need only be "sufficiently reasonable to preclude the Court of Appeals from substituting its judgment for that of the Agency")
Compare § 512(e) (1) (E) of the Act, which relates to the specific context of changes from the original application and provides for withdrawal of approval of a NADA for "changes from the standpoint of safety or effectiveness."