DEAR DOCTOR LETTERS
then analyzes the role of Dear Doctor letters in litigation in a post-Mensing
world, including whether Dear Doctor letters can be used to show causation
and whether Dear Doctor letters are admissible evidence at trial. The article
concludes with practical tips related to sending out Dear Doctor letters.
II. FDA REGULATIONS AND GUIDANCE REGARDING
DEAR DOCTOR LETTERS
A. 21 C.F.R. § 200.5
21 C.F.R. § 200.5 is the only Dear Doctor letter regulation, and has been
on the books since 1975.1 Despite a myriad of changes in FDA regulations
over nearly four decades, 21 C.F.R. § 200.5 has not had a single revision
since 1975. The regulation is short, straightforward, and very specific
about things such as typeface and font size, but it poses many ambiguities
for pharmaceutical manufacturers and distributors. In full, the regulation
§ 200.5 Mailing of important information about drugs.
Manufacturers and distributors of drugs and the Food and Drug
Administration occasionally are required to mail important information
about drugs to physicians and others responsible for patient care. In the
public interest, such mail should be distinctive in appearance so that it
will be promptly recognized and read. The Food and Drug
Administration will make such mailings in accordance with the
specifications set forth in this section. Manufacturers and distributors of
drugs are asked to make such mailings as prescribed by this section and
not to use the distinctive envelopes for ordinary mail.
(a) Use first class mail and No. 10 white envelopes.
(b) The name and address of the agency or the drug manufacturer or
distributor is to appear in the upper left corner of the envelope.
(c) The following statements are to appear in the far left third of the
envelope front, in the type and size indicated, centered in a rectangular
space approximately 3 inches wide and 2 1/4 inches high with an
approximately 3/8 inch-wide border in the color indicated:
(1) When the information concerns a significant hazard to health, the