The Value Of A Letter: The Importance Of Dear Doctor Letters

Dear Colleagues and Friends,

With email, cell phones, text messages, and social media, writing letters has become a thing of the past. For drug manufacturers (and the lawyers who represent them), however, it is the very act of letter writing that may help avoid liability in a lawsuit regarding an alleged failure to warn. This letter/review highlights the importance of the form and, especially, the timeliness of Dear Doctor letters. So, before you chuck your letter writing skills (i.e., inside address, greeting, body, complimentary close, and signature), note the information below.

Requirements and Guidance for Dear Doctor Letters

According to the U.S. Food and Drug Administration (FDA), Dear Healthcare Professional letters (also known as Dear Doctor letters) are pieces of correspondence mailed from a pharmaceutical product manufacturer or distributor to physicians and other healthcare professionals to convey important product safety information. 1 The federal regulation that governs Dear Doctor letters, in part, provides:

21 C.F.R. § 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. The regulation goes on to set forth certain requirements dependent on whether the Dear Doctor letter is intended to convey new information about: 1) a significant hazard to health; 2) important changes in the package labeling; or 3) a correction in product advertising or labeling.2 Additionally, the regulation specifies the proper form for Dear Doctor letters to include placement of the drug manufacturer's name and address, the font type and size, etc.3 The regulation itself is concise, but the FDA also issued a guidance to assist industry and FDA staff to "improv[e] communication of important safety information" in Dear Doctor letters.4

Although the FDA's guidance contains suggestions and "should be viewed only as recommendations" instead of requirements, any pharmaceutical manufacturer that intends to send a Dear Doctor letter should become familiar with the FDA's guidance on the subject.5 Moreover, the pharmaceutical manufacturer should actually work with the FDA to prepare the Dear Doctor letter prior to engaging in any mass mailing.6 Indeed, the FDA actually "believes that effective...