Source: https://openjurist.org/513/f2d/1063/edison-pharmaceutical-company-inc-v-food-and-drug-administration
Timestamp: 2017-10-19 20:59:56
Document Index: 239514785

Matched Legal Cases: ['§ 130', '§ 130', '§ 107', '§ 321', '§ 130', '§ 130', '§ 130']

513 F2d 1063 Edison Pharmaceutical Company Inc v. Food and Drug Administration | OpenJurist
513 F. 2d 1063 - Edison Pharmaceutical Company Inc v. Food and Drug Administration
513 F2d 1063 Edison Pharmaceutical Company Inc v. Food and Drug Administration
513 F.2d 1063
168 U.S.App.D.C. 273
EDISON PHARMACEUTICAL COMPANY, INC., Petitioner,
EDUCATION AND WELFARE, andCaspar W. Weinberger,
Education and Welfare,Respondents.
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 without a hearing if it does not contain the information required by Section 505(b). Instead petitioner contends that its submission more than meets what it characterizes as the "threshold evidentiary requirement" established by Hynson, Westcott and Dunning v. Richardson, 461 F.2d 215 (4th Cir. 1972), affirmed as modified on another issue27 sub nom. Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973), thereby entitling it to a hearing on the approvability of its NDA.28
There are no well-controlled studies using blind and double-blind cross-over and randomnization techniques or any other kind of control specified in 21 CFR 130.12(a)(5)(ii), so that neither the clinical nor statistical significance of the reported results can be evaluated.40
21 C.F.R. § 130.12(a)(5)(ii)(a)
21 C.F.R. § 130.12(a)(5)(ii)(c). The Regulation adds, however, that "(s)uch studies, carefully conducted and documented, may provide corroborative support of well-controlled studies regarding efficacy and may yield valuable data regarding safety of the test drug. Such studies will be considered on their merits in the light of the principles listed here . . .."
Under the doctrine enunciated in Eastern Railroad Presidents' Conference v. Noerr Motor Freight, Inc., 365 U.S. 127, 81 S.Ct. 523, 5 L.Ed.2d 464 (1961) and United Mine Workers of America v. Pennington, 381 U.S. 657, 85 S.Ct. 1585, 14 L.Ed.2d 626 (1965)
Under the "sham" exception to the Noerr-Pennington doctrine noted in California Motor Transport Co. v. Trucking Unlimited, 404 U.S. 508, 92 S.Ct. 609, 30 L.Ed.2d 642 (1971)
The issue was who has authority to determine whether Lutrexin was a "new drug" under the 1962 amendments. The Fourth Circuit had suggested that only a District Court could make this decision. 461 F.2d at 219. The Supreme Court held that FDA has that authority, subject to judicial review when administrative remedies have been exhausted. 412 U.S. at 623-634, 93 S.Ct. 2469
Drugs such as Lutrexin approved prior to the 1962 amendments were given two years to develop substantial evidence of effectiveness. This evidence was then examined by expert panels of the National Academy of Sciences-National Research Council, which reported their findings to FDA. If they reported that a drug lacked "substantial evidence of effectiveness," that drug's previously approved NDA could be withdrawn by FDA. Drug Amendments of 1962, § 107(c)(2) and (c)(3)(B), 76 Stat. 788, note following 21 U.S.C. § 321
412 U.S. 609, 93 S.Ct. 2469. Justices Brennan and Stewart took no part in the decision of the cases. Justice Powell filed an opinion joining in the Court's opinion on the issue of who has authority to determine whether Lutrexin was a "new drug" under the 1962 amendments (see footnote 27, supra ) and concurring in the result of the Court's opinion on the issue of whether Lutrexin should be given a hearing. He declined to agree "with any implications or conclusions in the Court's opinion to the effect that the regulations as construed and applied by the Commissioner in this case are either compatible with the statutory scheme or constitutional under the Due Process Clause. . . . Were we required to reach these issues, there might well be serious doubt whether the Commissioner's rigorous threshold specifications as to proof of 'adequate and well-controlled investigations,' coupled with his restrictive summary judgment regulation, go beyond the statutory requirements and in effect frustrate the congressional mandate for a prewithdrawal 'opportunity for hearing.' " 412 U.S. at 638, 93 S.Ct. at 2487
412 U.S. at 620-621, 93 S.Ct. at 2479. The Court added in a footnote that "(t)his applies, of course, only to those regulations that are precise. For example, the plan or protocol for a study must include '(a) summary of the methods of analysis and an evaluation of data derived from the study including any appropriate statistical methods.' 21 CFR § 130.12(a)(5)(ii)(a)(5). A mere reading of the study submitted will indicate whether the study is totally deficient in this regard. Some of the regulations, however, are not precise, as they call for the exercise of discretion or subjective judgment in determining whether a study is adequate and well controlled. For example, § 130.12(a)(5)(ii)(a)(2)(i) requires that the plan or protocol for the study include a method of selection of the subjects that provide 'adequate assurance that they are suitable for the purposes of the study.' The qualitative standards 'adequate' and 'suitable' do not lend themselves to clear-cut definition, and it may not be possible to tell from the face of a study whether the standards have been met. Thus, it might not be proper to deny a hearing on the ground that the study did not comply with this regulation."
412 U.S. at 622, 93 S.Ct. at 2479
The Court noted, however, that "(t)here is a contrariety of opinion within the Court concerning the adequacy of Hynson's submission." But a majority were of the view that the submission was sufficient to warrant a hearing. 412 U.S. at 623, 93 S.Ct. 2469, at 2480
In Pharmaceutical Manufacturers' Association v. Richardson, the United States District Court for the District of Delaware used this phrase to define "substantial evidence" and "adequate and well-controlled clinical investigations." 318 F.Supp. at 309 (1970)
FDA has made much of the fact that petitioner never requested a waiver under 21 C.F.R. § 130.12(a)(5)(ii)(a)(5), alleging this danger. But in light of the history of this case it is unlikely that a request for waiver would have been granted.
The Supreme Court's test in Weinberger v. Hynson, Westcott & Dunning, 412 U.S. at 620, 93 S.Ct. 2469 at 2478
Weinberger v. Hynson, Westcott & Dunning, 412 U.S. at 621, 93 S.Ct. 2469
Reply Brief of Petitioner (US) at 31, Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973)