*1 сontrolling penalty provision was McGOWAN, Before TAMM and acceptance plea, of the the time of ROBB, Judges. Circuit imprisonmеnt maximum provided a year; under 18 not more than one PER CURIAM: punishable was a mis- so offense judgment appealed from is af- demeаnor. opinion of the firmed on the basis history of the FECA legislative (The Honorable District Court John H. 441(b) in the act as shows that Section Pratt, Judge). See 377 F.Supp. District surplusage finally adopted (D.D.C.1974). word “title” “Act” to change McGOWAN, Judge Circuit (concurring 441(b) of Section and the limitation rеsult): containing Sections 440 and the title 441(a) was inadvertent. affirming I concur in Court, unpersuasive I find two
Affirmed. (b) 441(a) (b)]. Ti- [now The Conference Committеe added S.Conf. Sess.; IV, Rep.No. 580, Cong., It moved Sec- 1st tle Provisions”. 92d H.Conf. “General 314(a) Cong., Rep.No. from Title III to Title 1st Sess. tions 92d IV. Sections 311 It thеn consolidated (1972). 11. Stat. 311(a) 314(b) into one section Section
1055 a ap- drug important in its opinion, advanced therapeutic theories bene- rely to them upon placing failure on fits or of pellees’ on the market a drug my reflect own doubts.1 peal аppears likely to to be misused. The FDA claims 355(d) that section authorized restricting view, the is my In critical issue wheth- a distribution to prescriрtion-only basis er, argue, regulations the at appellees as before the explicitly granted scope the the FDA. fall outside of author- issue 1951, in authority that the reg- by Congress the FDA. ity delegated to ulations at issue differ only in degree of the FDA has him- The Commissioner frоm a prescription-only restriction. uncertainty some expressed self on this Schmidt, The FDA in Although score. See arguments these havе some delivered on Nov. 1975 at the weight, Address not do find them ultimately Symposium, New Tulane Medical Orle- convincing. The word “safe” in sectiоn La.; ans, Schmidt, Changing is, Our 355(d) mind, my to interpreted best as Needed?, Change Laws: More requiring Address labelling the to include the evi- drug delivered on Octоber 1975 at the dence from testing, and the infer- Hopkins University therefrom, Johns of School Med- ences indicating the thera- icine, Baltimore, benefits, Md. Upon examining possible peutic dangers, and un- question, I have concluded—not certainties involved in use a drug, of diffiсulty great appellees without an aid to a physician conscientious in —that prevail. determining appropriate shоuld treat- ment. That view seems to me to accord provision the pivotal The Federal of most both the interpre- reasоnable Food, Drug Cosmetic Act is tation statutory language and the 355(d), which prohibits the § common understanding the of FDA’s drug application of a new proval unless mission. methadone is safe for its data adequate there are to establish that intended use notwithstanding possi- the “drug the is safe for use under the con- bility will that be employed in unin- recommended, prescribed, sug- ditions or tended fashions. gested proposed labeling in the thereof . .” FDA contends that The on controls distribution are pattern where there exists a documented in diffеrent kind from prescription-only drug contrary of to the intended restrictions. The latter pre- restrictions labelling, specified drug uses the self-diagnosis vent by layman. If approval unsafe unless is controls such restrictions had not permitted imposed. As a drug over distribution cоr- before labelling would have drug ollary, it that for a such as asserts both specific had to include medical evi- which there is substan- dеnce about drug a and all general misuse, the FDA must knowledge tial evidence of that a physician must to restrict distribution to in possess dеcide, have order to after reading of either disapproving the dilemma a labelling, avoid whether to administer a theory еxplicit grant Act, The first is that 21 U.S.C. § 801 et 355(d)(3) (1970) authority seq. § in 21 U.S.C. to authority vested exclusive in, methods used the facili- consider “the Department Justice tо monitor distribution of for, manufacture, ties and controls used drugs regulated by legislation. that See packing processing, drug” (empha- оf [a] F.Supp. at 829-30. Whatever the limits of the supplied) denying sis as a basis for enabling legis- FDA’s under its own application negative implication a creates that lation, simply inadequate there is basis for to consider lacks ade- concluding that Controlled Substances Act quacy controls on distribution after implicitly repealed any authority that See production. F.Supp. their regulate might possess to the channels of apparent applicability of a canon of statu- 707 of § distribution. See Title II the Con- tory is thin reеd construction itself a Act, (1970): trolled Substances here, on; stand reliance canon ob- on that Nothing chapter in this . shall be scurеs the fact that the' on distribu- controls any way affecting, modify- construed proposed regulations tion contained in the ing, 'repealing, superseding provisions entirely different nature the controls from Food, 355(d)(3). Drug, on discussed manufacture the Federal Cosmetic thеory passage second that Title II is great consequences one contend uses is and the drug. in- any drug is safe for its theory very that misuse are harmful. Under the labelling contains if tended use present framework,-however, I information, a it is evident that enough that must be addressed believe expected digest cannot be layman Congress. *3 medical information complicated mass upon it the bring to bear physician. practicing of a judgment prescription-only Thus, restrictions necessary per- to ensure that
basis to use intending accord-
sons ev- implications with the of medical
ance gathered by
idence and con- drug labelling can
tained in a dо so. on methadone involved The restrictions GAS TRANSMISSION COLUMBIA quite different. Without them CORPORATION, Petitioner, judg- an informed and sound medical safety and effective- ment about medical They can still be made. are de- ness signed COMMISSION, FEDERAL POWER instead to control Respondent, try have no intent to persons who use Pipe Company, Gas Line United purposes. drugs for Intervenor. no limit There would be almost adopted. were its view FDA’s If, No. 74-2105. exаmple, had concluded'before Court of Appeals, that without restrictions on metha- of Columbia Circuit. of the sort now contained done Act, 21 Argued Oct. possibility seq. 801 et high, misuse remained there would under its to its be no barrier regulatory scheme
having established complexity ultimately of that
adopted in that under 355(d) (and gen- of section promulgate implementing
eral 371(a)),
regulations in section comprehensive have established a scheme,
registration complete with de- record-keeping, security,
tailed and in- requirements.
spection do not believe grant
that the current au- contemplates
thority activity by such
FDA, аccepting but the FDA’s view require upholding far-ranging reg-
would
ulation of that sort.
Physicians pharma- and state-licensed uniformly responsible
cists have not been dealing
in undoubtedly and the FDA genuine
has cause to believe
that, respect tо both narcotic and drugs, regulation effective
non-narcotic public interest necessitates author- part on its to restrict distribution
ity when the risk of unintended
channels