"Dear Health Care Provider" (DHCP) letters alert doctors and providers about new or updated information concerning a drug or biologic, and are often distributed by mass mailings and email, as well as Internet postings. The FDA's recent guidance discusses (1) when to issue the letters, (2) what types of information should be included, (3) the organization of that information so that it is effectively communicated, and (4) formatting techniques to make the information more accessible. It also includes a "model" letter.
In most cases, DHCP letters should be issued to communicate important safety concerns that could affect the decision to use a drug or require a behavioral change with respect to use or prescription of a drug. These usually fall into the following categories: important drug warning letters (boxed warnings, contraindications, precautions, etc.), prescribing information letters (e.g., indications and usage) and correction of drug information letters.
The FDA recommends that DHCP letters clearly state the purpose of the letter, the new information, the existing information that has changed and those actions that can be taken in response to the new information.
The Guidance also consists of a number of organizational comments, such as which paragraph of the DHCP letter should contain what information.
Finally, FDA made a number of formatting suggestions, including use of a two-page limit, informative paragraph headings, and bullets & numbering where appropriate. The Guidance includes additional details about formatting a DHCP letter.
The Guidance is worth reading now, before you are faced with the urgency of preparing a DHCP letter. Readers would also be well-served reviewing the applicable rules at 21 C.F.R. § 200.5.
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