21 CFR 202.1 - Prescription-drug advertisements

Cite as21 CFR 202.1
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240 practice notes
  • Human drugs: Antibiotic drug certification; regulations repealed,
    • United States
    • Federal Register January 05, 1999
    • 5 de janeiro de 1999
    ...21 CFR Part 10 Administrative practice and procedure, News media. 21 CFR Parts 12 and 16 Administrative practice and procedure. 21 CFR Part 20 Confidential business information, Courts, Freedom of information, Government employees. 21 CFR Part 25 Environmental impact statements, Foreign rel......
  • Food for human consumption: Food labeling— Dietary supplements; effect on structure or function of body; types of statements, definition,
    • United States
    • Federal Register January 06, 2000
    • 6 de janeiro de 2000
    ...administration to infants). The agency has also regulated implied claims in prescription drug advertising. (See, e.g., Sec. 202.1(a)(3) (21 CFR 202.1(a)(3)) (prohibiting use in advertising of fanciful product or ingredient names that falsely imply that the drug or ingredient has some unique......
  • Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
    • United States
    • Federal Register August 29, 2006
    • 29 de agosto de 2006
    ...and ``labeling,'' as used in current part 207, include the promotional material described in current Sec. 202.1(l)(1) and (l)(2) (21 CFR 202.1(l)(1) and (l)(2)), respectively. We believe that this information is more appropriately included in the definitions of ``representative sampling of ......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • 29 de agosto de 2006
    ...and ``labeling,'' as used in current part 207, include the promotional material described in current Sec. 202.1(l)(1) and (l)(2) (21 CFR 202.1(l)(1) and (l)(2)), respectively. We believe that this information is more appropriately included in the definitions of ``representative sampling of ......
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113 cases
  • Ims Health Inc. v. Ayotte, No. 06-cv-280-PB.
    • United States
    • U.S. District Court — District of New Hampshire
    • 30 de abril de 2007
    ...labeling. See, e.g., Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 331(a), 352 (2000); FDA Prescription Drug Advertising Rule, 21 C.F.R. § 202.1 (1999). Existing regulations prohibit prescription drug advertising and labeling information that is false, misleading, or that lacks a "fair......
  • City of S.F. v. Purdue Pharma L.P., Case No. 3:18-cv-07591-CRB
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • 30 de setembro de 2020
    ...FDCA, because federal law does not permit marketing schemes comprised of falsehoods and omissions to promote prescription drugs.30 See 21 C.F.R. § 202.1. Thus, like in the MDL, Defendants interpret the FAC too narrowly.31Page 56 Second, Defendants rely on Strayhorn v. Wyeth Pharmaceuticals,......
  • O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • 30 de janeiro de 2008
    ...letters." (Pls.' Opp'n at 23.) This argument is illogical. All promotional material must be consistent with a drug's labeling. See 21 C.F.R. § 202.1. If the warning is prohibited in the labeling (the prescribing information), the warning is not permitted in promotional material. The FDA has......
  • Pennsylvania Employees Ben. Trust v. Zeneca, No. 05-5340.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • 17 de agosto de 2007
    ...Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels, 65 Fed.Reg. 81082, 81082 (Dec. 22, 2000); see also 21 C.F.R. § 202.1(l)(2) (stating that material such as "[b]rochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price li......
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51 firm's commentaries
  • On Suing Publishers
    • United States
    • LexBlog United States
    • 7 de abril de 2011
    ...The material published by PDR is all approved verbatim by the federal Food and Drug Administration, and published by PDR pursuant to 21 C.F.R. §202.1. In light of that fact, PDR’s own failure to perform independent tests on the products described cannot be deemed “malicious,” does not evinc......
  • Already DTC (Done Through Causation) – More Thoughts About A DTC Exception
    • United States
    • LexBlog United States
    • 20 de janeiro de 2011
    ...or on behalf of its manufacturer, packer, or distributor are hereby determined to be labeling as defined in section 201(m) of the act. 21 C.F.R. §202.1(l)(2) (emphasis added). Indeed, a lot of package inserts have patient-friendly information (often called “medication guides”) attached dire......
  • What If We Win? Off-Label Promotion & Product Liability
    • United States
    • LexBlog United States
    • 20 de março de 2017
    ...all, the promotional materials would still qualify as “labeling” under the FDA’s and the courts’ broad definition of that term. E.g., 21 C.F.R. §202.1(1)(2); Holmes v. Hospira, Inc., 2013 WL 12132046, at *10 (C.D. Cal. Jan. 10, 2013) (“FDA’s broad definition of labeling” “encompasses nearly......
  • What If We Win? Off-Label Promotion & Product Liability
    • United States
    • Mondaq United States
    • 20 de março de 2017
    ...all, the promotional materials would still qualify as "labeling" under the FDA's and the courts' broad definition of that term. E.g., 21 C.F.R. §202.1(1)(2); Holmes v. Hospira, Inc., 2013 WL 12132046, at *10 (C.D. Cal. Jan. 10, 2013) ("FDA's broad definition of labeling" "encompasses nearly......
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7 books & journal articles
  • The More Things Change: Improvement Patents, Drug Modifications, and the FDA
    • United States
    • Iowa Law Review Nbr. 104-3, March 2019
    • 1 de março de 2019
    ...as well. See 31 U.S.C. § 3729; Universal Health Servs., Inc. v. United States ex rel . Escobar, 136 S. Ct. 1989, 2003–04 (2016) . 318. 21 C.F.R. § 202.1(e)(6)(ii) (2018); see also id. § 201.57(c)(2)(iii) (“Any statements [on product labeling] comparing the safety or effectiveness of the dru......
  • Statins and Adverse Cardiovascular Events in Moderate‐Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims
    • United States
    • Journal of Empirical Legal Studies Nbr. 5-3, September 2008
    • 1 de setembro de 2008
    ...Promoting andProtecting the Public Health 159 (Alina Baciu, Kathleen Stratton & Sheila P. Burke eds., 2007)(citing five studies).6821 C.F.R. § 202.1(e)(6). Misleading advertising is deemed to cause a drug to be misbrandedunder the FDCA. Id., § 202.1(k). Introduction or delivery for intro......
  • Influencers: What Every Brand and Legal Counsel Should Know
    • United States
    • Landslide Nbr. 11-1, September 2018
    • 1 de setembro de 2018
    ...LetterstoPharmaceuticalCompanies/UCM457961.pdf. 17. 21 U.S.C. §§ 321(n), 331(a), 352(a), (n); see 21 C.F.R. § 202.1(e)(5). 18. See FAQs, supra note 4. 19. See id. Published in Landslide® magazine, Volume 11, Number 1, a publication of the ABA Section of Intellectual Property Law (ABA-IPL), ......
  • Direct‐to‐Consumer Drug Advertisements and the Informed Patient: A Legal, Ethical, and Content Analysis
    • United States
    • American Business Law Journal Nbr. 50-4, December 2013
    • 1 de dezembro de 2013
    ...accompanying text.15Our empirical analysis is limited to print advertisements, which are subject to “briefsummary” requirements. See 21 C.F.R. § 202.1(e) (Westlaw through Mar. 28, 2013). Ananalysis of broadcast advertising is beyond the scope of this article, although we hypothesizethat our......
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