DEAR DOCTOR LETTERS
responsible for patient care.”42 In the world of advanced medicine, with
physicians divided into hundreds of specialty areas, the regulation says little
about the scope of the mailer. Should the mailer be blasted to every
physician and health care professional—including pharmacists, physician’s
assistants, and nurses—in the United States?43 That would be impractical.
While the FDA provides some guidance on who the “target audience” for
a Dear Doctor letter should be, it is a wide-ranging audience: “all healthcare
providers who are likely to prescribe, dispense, or administer the drug and
others who would have a need to know the information being
disseminated.”44 Potential prescribers are usually the “most important
audience,” so the “manufacturer should make certain to direct the letter to
the full range of healthcare providers who would have occasion to prescribe
the drug, including nurse practitioners and physician assistants who have
prescribing authority.”45 Examples of other important recipients include (1)
emergency department or primary care doctors who may not prescribe the
drug, but may provide care for patients with a drug-induced adverse
reaction discussed in the letter, and (2) pharmacists who would be required
to distribute a new Medication Guide announced in the letter.46
Even with the FDA’s general guidance, the target audience may be
difficult to define. For example, “important” side effect information about
an arthritis drug likely should be sent not only to rheumatologists (and their
assistants and nurse practitioners) that may prescribe or administer the drug,
but also family medicine general practitioners, orthopedic specialists, and
nurses who need to be cognizant of the side effect. But if the side effect
relates to another medical specialty, such as cardiology, should the mailer
also be sent to cardiologists and cardiac surgeons too? Probably yes. And
for drugs that are prescribed by specialists to adults as well as children,
should all pediatricians be included as part of the distribution list, even
though they may not be the primary prescribers of the medication?
Probably yes, but it is a judgment call. As discussed above, direct
consultation with the FDA may help to properly define the target audience
in each individual situation.
Once the pertinent subset of physicians and healthcare providers is
42. 21 C.F.R. § 200.5.
43. Of course, many drugs have worldwide distribution. However, the manufacturer’s
and distributor’s international duties are presumably not covered by 21 C.F.R. § 200.5, and
are thus not within the scope of this article.
44. See 2010 Guidance for Industry, supra note 7, at 5. FOOD & DRUG ADMIN., DRAFT
GUIDANCE FOR INDUSTRY AND FDA STAFF, (Nov. 2010), http://www.fda.gov/downloads/