FDA is seeking greater control over the content and dissemination of "Dear Health Care Provider Letters" with a new draft guidance that calls for "FDA and the manufacturer [to] work together" on the missives.

Released Nov. 12, the new policy is intended to improve the communication of new safety information through the letters sent directly to physicians. FDA is seeking a role in helping sponsors to determine whether a "Dear Doctor" letter should be sent, how to present the information in the letter and to whom it should be sent.

The agency "encourages manufacturers to consult with the appropriate review division in the development of a DHCP letter to ensure that the letter clearly and accurately reflects both the manufacturer's and FDA's understanding of the issue and the action required to address the issue," the guidance states.

That consultation step could avoid the need to send out a corrective letter, the guidance adds.

The guidance extensively details how letters should be written and addressed. It recommends letters should not be longer than two pages and should include appropriate agency and manufacturer contact information. Each letter also should have a heading indicating the type of correspondence and a subject line with a summary of the issue.

It also goes into great detail about how letters should be formatted to create a standardized letter so physicians can quickly locate necessary information. Specifics were included about what should be addressed in the first, second and final paragraphs.

Letter Length, Type And Content Requirements

The agency laid out a hierarchy of Dear Health Care Provider letter types based on different types of content:

· "Important Drug Warning" letters: to be used for information that is to be added to the boxed warning, contraindications, or warnings and precautions sections of a product label,

· "Important Prescribing Information" letters: to be used for changes to the indications and usage and dosage and administration sections, and,

· "Important Correction of Drug Information" letters: to be used to correct false or misleading information in promotional labels or advertising that has been subject to a warning letter or other agency action.

"Dear Doctor" letters are not to be used only to announce new indications, the guidance instructs. The agency also recommends against including information about the number of prescriptions written for the drug, extensive details about study designs, and sponsor plans to further investigate safety problems.

FDA wants promotional material and other unnecessary information be kept out of the letters so their messages are not clouded. A study cited in the guidance found a connection between letter quality or perceived quality and the extent the information was considered important.

Make Sure Everyone Who Needs It Gets It

The new policy also gives FDA a role in deciding the appropriate audience for a letter, with the aim of ensuring all medical personnel who could benefit from the information receive it. The guidance indicates letters should be addressed to "the full range of health care providers who would have occasion to prescribe the drug, including nurse practitioners [and] physician assistants with prescribing authority." Non-prescribers who have an interest in knowing the new information also should be included on mailing lists.

As an example, the guidance notes that "a DHCP letter that announces the introduction of a new Medication Guide should be directed to pharmacists who would be required to distribute the Medication Guide to patients."

The agency also wants letter writers to check if the communication was effective. In what most certainly is a borrowed page from REMS policy, which requires assessments of all program elements - including "Dear Doctor" letters that are part of communication plans, the guidance calls for an evaluation of the letter's penetration into the target audience and its awareness of the new information.

"For letters that are intended to modify behavior in the target audience, ideally there would also be an evaluation of the extent to which the DHCP letter changed behavior in the manner described," the guidance states.

The draft guidance applies to correspondence that is part of REMS communication plans, if appropriate, as well as for electronic "Dear Doctor" letters. Comments will be accepted until Jan. 11.

-Derrick Gingery (d.gingery@elsevier.com)

FDA Wants To Consult Before Manufacturers Send "Dear Doc" Letters

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