C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 312—INVESTIGATIONAL NEW DRUG APPLICATION › Subpart A—General Provisions

21 C.F.R. § 312.7

Promotion of investigational drugs

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(a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.

(b) Commercial distribution of an investigational new drug. A sponsor or investigator shall not commercially distribute or test market an investigational new drug.

(c) Prolonging an investigation. A sponsor shall not unduly prolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 19476, May 22, 1987; 67 FR 9585, Mar. 4, 2002; 74 FR 40899, Aug. 13, 2009]
Notes of Decisions
Cited in 7 cases, 1993–2017 · leading case: Physicians Healthsource, Inc. v. Boehringer Ingelheim Pharm., Inc., 847 F.3d 92 (2d Cir. 2017).
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Physicians Healthsource, Inc. v. Boehringer Ingelheim Pharm., Inc., 847 F.3d 92 (2d Cir. 2017). · cites it 4× “24 See 21 C.F.R. § 312.7 (a)(prohibiting, inter alia, pharmaceutical 25 companies from “promoting” drugs not yet approved by the FDA).”
Ortho Pharm. Corp. v. Cosprophar, Inc., 828 F. Supp. 1114 (S.D.N.Y. 1993). · cites it 3× “21 C.F.R. § 312.7 (1992). For a more detailed discussion, see infra n.”
United States Ex Rel. Franklin v. Parke-Davis, Div. of Warner-Lambert Co., 147 F. Supp. 2d 39 (D. Mass. 2001). “Cf 21 C.F.R. § 312.7 (prohibiting manufacturer from charging for an investigational new drug in a clinical trial without the prior written approval of the FDA).”
United States Ex Rel. Zissler v. Regents of the Univ., 992 F. Supp. 1097 (D. Minnesota 1998). · cites it 2× “§ 355 ; 21 C.F.R. §§ 312.7 (b) & (d), 312.7(d)(3).”
Abigail All. for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007). “34 (b)(3) (preventing access to experimental drugs for terminally ill patients where there is insufficient evidence of effectiveness or where there is an unreasonable risk of injury) and 21 C.F.R. § 312.7 (prohibiting drug manufacturers from profiting on the sale of experimental…”
Abigail All. for Better Access v. Von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007). “34 (b)(3) (preventing access to experimental drugs for terminally ill patients where there is insufficient evidence of effectiveness or where there is an unreasonable risk of injury) and 21 C.F.R. § 312.7 (prohibiting drug manufacturers from profiting on the sale of experimental…”
Richard Yocum v. Rockwell Med. Tech., 614 F. App'x 915 (9th Cir. 2015). “Yocum has not argued that Rockwell engaged in an actual violation of these regulations. Additionally, although he argues in his briefs that he reasonably believed Rockwell had violated these regulations, he has not presented any evidence that he held those beliefs during the…”
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