DEAR DOCTOR LETTERS
identified, there comes the not-so-simple issue of obtaining their mailing
information. Typically, this is not public information and manufacturers
and distributors must obtain ( i.e., pay for) mailing lists from private
consultants, which, in our experience, can be quite pricey. Consideration
may be given to using contact lists from medical associations and specialty
organizations, such as the American Medical Association or the American
College of Cardiology. The problem, of course, is that such voluntary
membership associations do not capture the full target audience.
Needless to say, the manufacturer sending out a Dear Doctor letter does
not want to be in the position of sending out key drug information to fewer
than all of the affected healthcare professionals, subjecting itself to failure-to-warn lawsuits by plaintiffs whose doctors prescribed the drug without the
benefit of the Dear Doctor letter.
5. The Mechanism: First Class Mail Or Electronic Means
After reviewing 21 C.F.R. § 200.5, the manufacturer may wonder if it
still has to use “first class mail and No. 10 white envelopes.” There is a
clear answer to this question. E-mail or other electronic communications
will suffice as long as they are equally efficient tools.47 The FDA has
additional guidelines on “Using Electronic Means to Distribute Certain
Product Information” (March 2006).48 These include:
The subject line of the communication should include a signal of
its importance, similar to the bold headers in mailings, together
with the name of the drug product.
The body of the communication should be concise, clear and
identify the consequence if the information is not followed or
used in the medical treatment of patients.
The communications should not be promotional or contain links
to promotional materials.49
B. Dear Doctor Letters as Label Changes
Despite the myriad ambiguities that surround when, how, and to whom
Dear Doctor letters should be sent, there is no doubt that courts and the
FDA consider Dear Doctor letters to fall under the purview of “Drug
47. See 2010 Guidance for Industry, supra note 7, at 1 (“These recommendations are
also intended to apply to [Dear Doctor] letters distributed by electronic means (e.g., email) to
the extent practical for the type of electronic communication used.”).
48. See 2010 Guidance for Industry, supra note 7, at 6.