21 CFR 202.1 - Prescription-drug advertisements
| Cite as | 21 CFR 202.1 |
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239 practice notes
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Human drugs: Antibiotic drug certification; regulations repealed,
...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......
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Human drugs: Antibiotic drug certification; regulations repealed,
...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......
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Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
...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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Human drugs and biological products:
Prescription drug products; labeling requirements,
...further described in that provision. FDA-approved labeling also accompanies ``promotional'' materials, as described in Sec. 202.1(l)(2) (21 CFR 202.1(l)(2)). FDA-approved labeling also ``bears adequate information'' within the meaning of Sec. 201.100(c)(1), which applies to ``labeling on or......
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113 cases
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Ims Health Inc. v. Ayotte, No. 06-cv-280-PB.
...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......
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City of S.F. v. Purdue Pharma L.P., Case No. 3:18-cv-07591-CRB
...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,......
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O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
...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......
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Pennsylvania Employees Ben. Trust v. Zeneca, No. 05-5340.
...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
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On Suing Publishers
...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......
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Already DTC (Done Through Causation) – More Thoughts About A DTC Exception
...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......
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What If We Win? Off-Label Promotion & Product Liability
...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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What If We Win? Off-Label Promotion & Product Liability
...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
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The More Things Change: Improvement Patents, Drug Modifications, and the FDA
...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......
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Statins and Adverse Cardiovascular Events in Moderate‐Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims
...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 introduct......
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Influencers: What Every Brand and Legal Counsel Should Know
...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), ......
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Direct‐to‐Consumer Drug Advertisements and the Informed Patient: A Legal, Ethical, and Content Analysis
...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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