FDA Concedes Overreach in Draft Guidance on 'Dear Health Care Provider' Letters

Posted 09 July 2013 | By Alexander GaffneyRF News Editor

The US Food and Drug Administration (FDA) has announced that it is in the process of finalizing a draft guidance first released in 2010 pertaining to "Dear Health Care Provider" (DHCP) letters, a form of communication meant to inform a healthcare professional about important information associated with a healthcare product.

Background

In November 2010, FDA released a draft guidance on DHCP letters entitled Dear Health Care Provider Letters: Improving Communication of Important Safety Information. The guidance makes a number of recommendations to industry on how DHCP letters should be formatted and the content that should be contained within them.

Among the central recommendations of the draft guidance document: Manufacturers should work with FDA to determine whether a DHCP letter is necessary, how the new information should be presented, and to which audience the letter should be sent. One situation FDA particularly wants to avoid is a manufacturer sending a letter to a healthcare provider that inaccurately conveys the issue affecting the product, which could serve to further exacerbate the problem.

The guidance goes on to clarify the situations in which a DHCP letter would be needed (typically for unknown or serious adverse events, important new information about a safety issue, a drug interaction that could be threatening, removal of an indication or a change in the recommended dose), as well as in-depth information about the format of the letter (In order: purpose, new information, explanation of status quo, action to be taken).

Feedback

FDA would ultimately receive 16 comments on the draft guidance, including ones from PhRMA, BIO, Sunovion, Roche/Genentech, Novo Nordisk, Hoffmann-La Roche, Boehringer Ingelheim, Bausch+Lomb, Sanofi Aventis, the American College of Cardiology and the American Academy of Pediatrics.

FDA said the comments received mainly touched on two issues:

Section V of the draft guidance states that the target audience should be all health care providers who could not only prescribe the drug, but who could also dispense or administer the drug. The respondents said this definition expanded the target audience to include nurses, pharmacists and other prescribing entities, making it more difficult to send the letters.

In Section VI of the draft guidance, FDA recommends that companies conduct an evaluation of the extent to which the target audience received the DHCP letter and is aware of the information that was communicated in the letter. It also asked manufacturers to assess the impact of DHCP letters and their impact on patient behavior. Comments found this overly burdensome, beyond the Agency's statutory authority, and an unnecessary increase in correspondence, thereby potentially diluting the impact of the DHCP letters.

To the first point, FDA said the regulation on which DHCP letters are based already requires manufacturers to mail important information to "physicians and others responsible for patient care."

"To the extent this includes non-prescribing health care professionals responsible for patient care, the manufacturers should send letters to relevant personnel," FDA wrote. "This is not an expansion of the scope of the letters, merely a clarification of the regulation and a reflection of the health care system today, which has a variety of practitioners involved in patient care."

Regulatory Overreach

To the second point, FDA said it agreed with the comments that Section VI of the draft guidance was an overreach, and said it had modified the final guidance to "suggest that manufacturers conduct an evaluation for their own use of the utility of the letters and their success in reaching the target audiences."

FDA said it further estimates that it will receive approximately 30 DHCP letters per year from 25 manufacturers, with each letter taking 100 hours for a manufacturer to complete.

FDA also said the final guidance has been submitted to the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) for final approval. OIRA's approval process is highly variable, taking as more than a year in some cases, but generally concludes in a few months for most low-impact guidance documents.

Additional comments on the guidance are due to FDA by 8 August 2013.


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