Mutual Pharmaceutical Company, Inc., Petitioner v. Karen L. Bartlett (570 U.S. 472)
U.S. Supreme Court · decided June 24, 2013 · Supreme Court Database (Spaeth)
- Citation
- 570 U.S. 472 · 133 S. Ct. 2466
- Docket
- No. 12-142
- Argued
- March 19, 2013
- Decided
- June 24, 2013
- Term
- October Term 2012
- Vote
- 5–4
- Majority author
- Justice Alito
- Issue area
- Federalism
- Disposition
- Reversed
- Outcome
- Petitioning party won
- Ideological direction
- Liberal
How the Justices voted
- Majority
- Chief Justice Roberts, Justice Scalia, Justice Kennedy, Justice Thomas, Justice Alito (wrote)
- Dissenting
- Justice Ginsburg, Justice Breyer (wrote), Justice Sotomayor, Justice Kagan
Oral argument transcript and advocates · Opinion on Justia
Opinion excerpt
(Slip Opinion) OCTOBER TERM, 2012 1 Syllabus NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321 , 337. SUPREME COURT OF THE UNITED STATES Syllabus MUTUAL PHARMACEUTICAL CO., INC. v. BARTLETT CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIRST CIRCUIT No. 12–142. Argued March 19, 2013—Decided June 24, 2013 The Federal Food, Drug, and Cosmetic Act (FDCA) requires manufac- turers to gain Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce. 21 U. S. C. §355 (a). Once a drug is approved, a manufacturer is pro- hibited from making any major changes to the “qualitative or quanti- tative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.” 21 CFR §314.70 (b)(2)(i). Generic manufacturers are also prohibited from making any unilateral changes to a drug’s label. See §§314.94(a)(8)(iii), 314.150(b)(10). In 2004, respondent was prescribed Clinoril, the brand-name ver- sion of the nonsteroidal anti-inflammatory drug (NSAID) sulindac, for…
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