Yesterday, the US Food and Drug Administration (FDA) made available its final guidance on Dear Health Care Provider Letters: Improving Communication of Important Safety Information (DHCP Letter Guidance).1 The guidance provides specific instructions to industry on the content and format of Dear Health Care Provider (DHCP) letters to better ensure effective communication of information to health care professionals.
Under FDA regulations, drug manufacturers and distributors are required to communicate important drug information—including warnings, other prescribing information, and corrections—to health care professionals.2 The regulation is limited to mailing, and more specifically, to the distinctive appearance of envelopes used to mail such information. Because FDA’s regulation does not provide instructions on the format and content of the actual DHCP letter, nor does it address DHCP communications made electronically or by other means, the new guidance is intended to fill these gaps and help improve the effectiveness of DHCP letters in communicating important drug information. The guidance finalizes FDA’s draft guidance on the same topic issued more than three years ago.3
Important Guidance Information
The DHCP Letter Guidance provides specific recommendations on when companies should issue a DHCP letter, the type of information that should be included in the letter, and the format and content of the letter to ensure that information is accessible and communicated effectively to health care professionals.
In accordance with the guidance and to ensure the effectiveness of DHCP letters, FDA recommends that a manufacturer work with FDA to determine the following:
- Whether a DHCP letter should be issued to communicate new information. This includes important new safety information, important prescribing information (other than safety), corrections of false or misleading information in promotional materials, as well as information related to Risk Evaluation and Mitigation Strategies (REMS), how to improve the effectiveness of a drug, and drug shortages.
- How to present the new information in the DHCP letter. The guidance provides detailed recommendations for the content of DHCP letters, as well as instructions for formatting to ensure accessibility and readability. Appendices to the guidance provide three model letters as examples.
- The target audience for the DHCP letter. The guidance recommends that manufacturers identify the intended target audience for the DHCP letter to ensure it is “directed more selectively” to appropriate health care providers.4 The examples provided suggest that DHCP letters should be distributed primarily to relevant health care professionals; however, a separate section of the guidance states that a DHCP letter should be directed not only to relevant health care professionals, but also to “others who need to know the information.” The latter category extends beyond health care professionals who are “likely to prescribe, dispense, or administer the drug” to encompass “the full range of health care professionals who could prescribe the drug” and “health care providers who may need to know the information even if they do not prescribe the drug.”5 Because the scope of the intended audience appears to have no limits, manufacturers should consult the appropriate review division to discuss the range of distribution and appropriate recipients.
- The time frame for distributing the DHCP letter. FDA recommends that the intended audience receives the information promptly, in consideration of the importance of the issue being communicated.
Finally, according to the DHCP Letter Guidance, manufacturers should assess the impact of the DHCP letter, including an evaluation of “the extent to which the target audience received the DHCP letter and is aware of the information communicated in the letter.”6 Significantly, the guidance does not appear to require that the assessment be reported to FDA, but rather is limited to the manufacturer’s internal use.