FDA appears to have found problems on both the senders’ and recipients’ sides of “Dear Health Care Provider Letters” and issued guidance recommending effectiveness assessments and formatting specifications in an attempt to give the correspondence more impact.

The intent of the draft guidance, released Nov. 12, was to create a standardized look for DHCP letters and ensure they only contain information about important safety and labeling changes.

FDA also wants to limit the potential uses for the DHCP letter. Promotional pitches and prescribing statistics deemed non-essential are not to be included. New indications alone are not a suggested reason for one to be sent.

The agency said the guidance was needed because “it was apparent that there was considerable room for improvement” in how the letters communicated the information, based on experience and research. It would not say there was an emerging trend of letters being overly promotional, although there have been cases where it has occurred.

“The agency does not have any information that would suggest DHCP letters have been overused or that there has been inappropriate use,” FDA said in an e-mail. “The purpose of the guidance is to ensure consistency, quality and clarity among the various DHCP letters issued by industry.”

Learning From Avandia

Recent controversy over a DHCP letter related to the drug Avandia (rosiglitazone) also may have influenced FDA as it prepared the document for release.

In the new guidance it inserted itself into the DHCP letter process. Agency consultation with manufacturers on content and audience is recommended before the letters are sent. The step could prevent the agency from forcing companies to send a corrective letter later, it said in the guidance.

Recipients also may eventually expect evidence of FDA oversight. The guidance allows for a mention of the agency’s review of the letter.

The oversight idea comes after the agency took heavy criticism for not regulating a DHCP letter it required of GlaxoSmithKline to explain the results of a joint advisory committee meeting on Avandia.

When FDA put a partial clinical hold on the Thiazolidinedione Intervention with Vitamin D Evaluation study, which tested Avandia against Actos (pioglitazone), it required Glaxo to inform TIDE investigators, ethics committees and institutional review boards about the advisory committee meeting and summarize the deliberations, recommendations and votes.

Whistleblower David Graham and some advisory committee members later attacked the DHCP letter GSK sent, saying it did not include any information critical of Avandia and failed to mention the higher heart attack risk compared to Actos.

FDA said it did not pre-clear or approve the content (“Avandia Critics Try Drug In Court Of Public Opinion, Turn Up Heat On FDA,” “The Pink Sheet,” Aug. 23, 2010).

Busy Physicians Diminish Letter Effectiveness

The letters’ potential targets, physicians and health care workers, also bear some of the responsibility for the problem, the agency said.

“There are concerns that DHCP letters do not receive the attention they should from busy health care providers who receive large amounts of new information on a constant basis,” the agency said.

For that reason, FDA recommended manufacturers check the effectiveness of the letters once they are sent, including determining whether physician and prescriber behavior is being affected. It is a tool the agency already uses with Risk Evaluation and Mitigation Strategies, and not surprisingly, the guidance could apply to correspondence that is part of a REMS communication plan. The guidance also applies to electronic DHCP letters.

The American Medical Association would not comment on the draft guidance at this time.

Study Indicates Letter Problems

The agency took its cue in part from a study conducted by K.M. Mazor that looked at letters sent in 2000 and 2001.

In the study, published in 2005, of the 32 DHCP letters sent, physician ratings suggested 25% were unclear and 28% were not effective overall. Thirty-six percent of the letters had an unacceptable ratio of relevant to supporting information and 36% could not find key information easily.

The study concluded some DHCP letters do not communicate labeling changes effectively. It suggested special formatting and wording for letters intended to emphasize new information. Length and key information placement were not correlated with ratings, according to the study abstract.

The guidance suggests, sometimes in heavy detail, how the letters should look.

It outlined three distinct types for the letters: “Important Drug Warning,” “Important Prescribing Information,” and “Important Correction of Drug Information,” and stated they are to be labeled clearly and prominently on the envelope and letterhead to indicate the type of correspondence.

The guidance also recommended letters not exceed two pages in length and stated what information should go in the first, second and final paragraphs, as well as who should receive the letters (Also see "FDA Wants To Consult Before Manufacturers Send "Dear Doc" Letters" - Pink Sheet, 12 November, 2010.).

The rigid formatting suggestions and expectations for where certain information or instructions should appear likely are intended to solve providers’ time problems. Physicians can quickly find the instructions or label change they need if they know to look in the same place each time.

“Dear doctor” letters traditionally have been seen as a strong defense against product liability litigation – the idea being that the company took the responsible step of alerting the health care community and thus prescribers and dispensers should have been able to adequately inform patients about risks (Also see "Ingredients For Product Liability Litigation: From FDA Actions To Foreign Labels" - Pink Sheet, 29 November, 2010.).

The hands-on approach outlined in the draft guidance could make those protections even stronger. "The impact of the guidance on products’ liability and preemption litigation is unclear," law firm Sidley Austin notes in a briefing memo on the document, but "such defenses may be particularly strong where FDA is involved with deciding whether to issue a DHCP letter and its contents and distribution."

Comments on the draft are due by Jan. 11

By Derrick Gingery

FDA Standardizing “Dear Doc” Letters To Fix Problems With Recipients As Much As Senders

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