DEAR DOCTOR LETTERS
letter may be in the form of an FDA press release or public health
advisory.34 Or, the corrective action may be a request that the manufacturer
“issue an appropriately revised letter and labeling/promotional materials (as
3. The Sender: Manufacturer/Distributor or FDA
Once the decision has been made to send out a Dear Doctor letter, who
should mail it? 21 C.F.R. § 200.5 states that both the FDA and
manufacturer “will” send out “Dear Doctor” letters.36 As a practical matter,
however, the FDA rarely sends out such letters itself.37 The FDA
recognizes that “typically” they will not be the one to issue these letters.38
For example, they may choose to post the manufacturer’s or distributer’s
letter on its MedWatch website.
The FDA also recognizes that they will not always be consulted about a
Dear Doctor letter before it is sent out.39 However, since the letter may end
up on the FDA’s MedWatch website, and even more importantly, since the
letter is deemed part of the drug’s label,40 a manufacturer or distributor that
is seriously considering sending out a letter should consult with the FDA
for review and approval of the letter. The Eleventh Circuit has noted that
“FDA approval must be sought prior to issuing such a letter, as it is
considered a change in package labeling.”41 As discussed above, the
manufacturer or distributor who decides not to inform the FDA makes that
decision at its own peril.
4. The Recipient: “Physicians And Others Responsible For Patient Care”
After the manufacturer or distributor decides that a Dear Doctor letter is
needed (or “required”), who should the letter be mailed to? 21 C.F.R. §
200.5 provides that the mailer should be sent to “physicians and others
(DDMAC)] will initiate an enforcement action that may lead to corrective actions.”).
34. Id. at 7-8.
35. Id. at 8.
36. 21 C.F.R. § 200.5 (“The Food and Drug Administration will make such mailings in
accordance with the specifications set forth in this section.”) (emphasis added).
37. See NDAs: “Dear Healthcare Professional” Letters, supra note 6, at 3.
38. See id.
39. Id. at 1 (“The FDA may or may not be involved in reviewing these DHCP letters
before they are mailed.”); id. at 7 (“Occasionally, FDA does not learn about a [Dear Doctor]
letter until after it has been distributed.”)
40. See infra Section II(b).
41. See, e.g., Christopher v. Cutter Labs., 53 F.3d 1184, 1187 n.3 (11th Cir. 1995)