DEAR DOCTOR LETTERS
Labeling.”50 This further complicates the already difficult decision facing
manufacturers regarding whether to send a Dear Doctor letter, because with
every Dear Doctor letter sent, a manufacturer is effectively changing its
drug’s label. And, as all manufacturers know, making or failing to make
label changes can have serious consequences if litigation ensues.When is a
label change necessary? Under FDA regulations, a label change is required
“as soon as there is reasonable evidence of an association of a serious
hazard with a drug; a causal relationship need not have been proved.”51 Of
course, obtaining FDA approval for a label change can be a time-
consuming, drawn-out, and expensive proposition. When the drug label
change is time-sensitive, a brand name drug manufacturer52 may, on its own
accord, use the Changes Being Effected (“CBE”) process to change the
label to add to or strengthen a warning or adverse event description while
concurrently submitting a supplement to obtain formal approval for that
change.53 This permits a pharmaceutical manufacturer to rapidly distribute
a new warning while meeting the formal requirement for FDA approval of
all labeling changes.54 The FDA may subsequently reject the change, at
which time the label must be changed back. If the FDA approves the
change, then the label can remain as is. The FDA reserves similar rights to
reject or correct label changes suggested in Dear Doctor letters that are not
approved in advance by the FDA.55
III. DEAR DOCTOR LETTER CASE LAW: LESSONS IN PREEMPTION,
FAILURE TO WARN, AND POST-REMEDIAL MEASURES
The ambiguity surrounding Dear Doctor letter regulation, combined with
the fact that Dear Doctor letters constitute drug labeling, has created a
minefield for drug manufacturers and plenty of fodder for failure-to-warn
cases against them. This section will discuss the role of the Dear Doctor
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).