DEAR DOCTOR LETTERS
As discussed below, Dear Doctor letters are considered part of a drug’s
labeling,15 and the FDA’s guidance makes clear that if the important drug
information is not “important” enough to wind up in the package insert, it
probably should not be the subject of a Dear Doctor letter.
d. Important Prescribing Information
“Important Prescribing Information” letters “should be used to convey
important changes to prescribing information other than those changes that
should be described in an Important Drug Warning Letter[.]”16 The letter
“should ordinarily be used to convey substantive changes to the
INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION
sections.”17 The FDA provides the following examples:
A change in the INDICATIONS section intended to minimize
risk or improve effectiveness
A change to the dose or dosage regimen intended to minimize
risk or improve effectiveness18
Again, this is the kind of information that would make a drug
manufacturer or distributor believe that a change in the label was in order.
Of note, the FDA cautions that such an “Important Prescribing Information”
letter “should not be used merely to announce a new indication.”19 In other
words, this is not a letter to advertise new uses for the drug, but rather to
reduce the risk and increase the effectiveness for previously indicated uses.
Some sample Dear Doctor letters falling under the category of
“Important Prescribing Information” are a November 2011 Dear Doctor
letter advising that the FDA had revoked its approval of Avastin for the
treatment of metastatic breast cancer,20 and a June 2011 letter with new
14. Letter from Matthew Davis, Senior Vice President, AR Scientific, Inc., to
Healthcare Provider (Aug. 16, 2012), available at http://www.pdr.net/drugpages/product
safetyalert.aspx?ha=1000138. The Dear Doctor letter contained the text of the Black Box
warning, which advised that “[t]he risk associated with Qualaquin use in the absence of
evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps
outweighs any potential benefit” and identified thrombocytopenia and chronic renal
impairment as possible adverse effects of the off-label use.
15. See infra Section II( B).
16. See 2010 Guidance for Industry, supra note 7, at 3.
18. Id. at 3-4.
19. Id. at 4.
20. Letter from Hal Barron, Chief Medical Officer, Genetech, to Healthcare Professional
(Nov. 18, 2011) available at http://www.pdr.net/drugpages/hapdf/1176-11%20PDRAlrt%20