Source: http://www.annalsofhealthlaw.com/annalsofhealthlaw/vol_22_issue_3?pg=92
Timestamp: 2019-04-21 22:09:03+00:00

Document:
50. Drug labeling is governed by a complicated scheme of federal regulations. In particular, Title 21, Part 200 of the Code of Federal Regulations details labeling requirements. Under the Regulations, “Dear Doctor” letters are considered part of a drug’s label. 21 C.F.R. § 321(m); U.S. v. Guardian Chem. Corp., 410 F.2d 157, 160-61 (2nd Cir. 1969) (“In order to ‘accompany’ an article and thus constitute ‘labeling’ for it, printed pamphlets or brochures need not be shipped along with the article; they may be sent out either before or after the article and still ‘accompany it.’”).
51. 21 C.F.R § 201.80(e) (2012); 21 C.F.R. § 201.57(e) (2005).
52. This option is not available to generic drug manufacturers. See Pliva v. Mensing, 131 S. Ct. 2567, 2576 (2011).
53. See 21 C.F.R. § 314.70(c)(6) (2012).
54. In fact, the FDA’s briefing in the Mensing case suggested that the CBE process is the only permissible means for adding to or strengthening a warning. See Brief for the United States as Amicus Curiae Supporting Respondent, Pliva, Inc. v. Mensing, Nos. 09- 993, 09-1039, WL 4339894, at *6-7 (U.S. Nov. 2, 2010).

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