On July 9, 2013, the United States Food and Drug Administration (FDA) announced a modification of certain recommendations contained in the November 2010 draft guidance (Guidance) relating to the content, format, and dissemination of Dear Health Care Provider (DHCP) letters communicating important safety information by manufacturers or distributors of medications or biologics. Specifically, the FDA revised a provision recommending that manufacturers evaluate the extent to which their target audience receive the letters and are aware of the communicated information and removed a provision requiring manufacturers to assess the overall impact of the letters on behavior modification.
Regulating the Content of Dear Health Care Provider Letters
The November 2010 Guidance details recommendations relating to the content and format of DHCP letters. See 75 FR 69449 (Nov. 12, 2010). DHCP letters are used to inform health care professionals about important new safety concerns that “could affect the decision to use a drug or require some change in behavior by health care practitioners, patients, or caregivers to reduce the potential for harm from a drug.” FDA Draft Guidance for Industry, “Dear Health Care Provider Letters: Improving Communication of Important Safety Information, (issued Nov. 12, 2010), available here. [“FDA November 12, 2010 Draft Guidance”] DHCP letters can also be sent to “correct misinformation in advertising or other types of prescription drug promotion.” Id.
The Guidance suggests that “to effectively communicate new information,” a DHCP letter should clearly indicate:
- The purpose of the letter;
- The new information;
- Any existing information that has changed; and
- Any actions a health care provider should take in response to the new information.
DHCP letters are considered to be part of a medication’s label. See 21 U.S.C. § 321(m) (2013). The FDA estimates that the agency receives annually approximately 30 DHCP letters from 25 manufacturers, with each letter requiring an average of 100 hours for manufacturers to prepare and complete. Thus, the agency anticipates an “annual reporting burden” of 3,000 hours per year. See 78 FR 41065 (July 9, 2013).
A manufacturer’s DHCP letter “should be directed to all health care providers who are likely to prescribe, dispense, or administer the drug and others who would have a need to know the information being disseminated.” FDA November 12, 2010 Draft Guidance. The Guidance explains that “[o]rdinarily, potential prescribers — the gatekeepers to access to the drug — would be the most important audience for a DHCP letter. Therefore, a manufacturer should make certain to direct the letter to the full range of health care providers who would have occasion to prescribe the drug, including nurse practitioners and physician assistants who have prescribing authority.” Id.
According to the FDA, formal and informal evaluations show that the communication quality of DHCP letters – the extent to which the information is accessible and can be understood – varies widely. As a result, the Guidance focuses its recommendations on (a) when to use a DHCP letter, (b) the types of information to include in a letter, (c) how to organize that information, and (d) formatting techniques to make the information more accessible.
Modifications to the FDA’s November 2010 Draft Guidance
a) Evaluating the Impact of DHCP Letters
Section VI of the Guidance introduced two tracking models for manufacturers to use to assess the impact of DHCP letters, evaluating (1) receipt and conveyance of information contained, and (2) modifications to behavior.
First, for letters intended to modify behavior, the Guidance suggests that manufacturers should actively monitor the extent to which they succeed in changing behavior. After receiving comments in response to the Guidance, the FDA decided to eliminate the recommendation that manufacturers evaluate changes in behavior. See 78 FR 41065 (July 9, 2013). This retraction of Section VI of the Guidance was the result of nine of the eleven comments asserting that the proposal would be “overly burdensome [and] beyond the Agency’s statutory authority.” 78 FR 41065 (July 9, 2013). For example, in its January 11, 2011 comments to the FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing biopharmaceutical researchers and biotechnology companies in the United States, explained that a proposal requiring an evaluation of patient behavior would “unnecessarily increase the number of correspondence regarding the letters and dilute the impact of the important information in the letters themselves.” See Correspondence from PhRMA to FDA re: Comments on Docket No. FDA-2010-D-0319 (Jan. 11, 2011).
Second, to measure the letters’ overall effectiveness, the Guidance proposed that manufacturers “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.” Id. The FDA revised this language to now suggest that “manufacturers conduct an evaluation for their own use of the utility of the letters and their success in reaching the target audiences.” 78 FR 41065 (July 9, 2013). This modification provides further clarity to the industry, as the Guidance was previously silent on reporting requirements and submissions of evaluations to the FDA.
b) Dissemination of the DHCP Letters
Of particular interest is the FDA’s decision to retain its original recommendation that the DHCP letter be directed to “all health care providers who are likely to prescribe, dispense, or administer the drug.” See FDA November 12, 2010 Draft Guidance. Therefore, a letter announcing the introduction of a new Medication Guide to be distributed by pharmacies to patients when a medication is dispensed should be directed to those distributing pharmacies.
The Guidance also recommends sending DHCP letters to health care providers who might not prescribe the medication, “but for whom it would otherwise be important to know the information in the letter.” Id. This would require manufacturers to assess the inclusiveness of their lists of non-prescribing health care providers in an effort to disseminate letters more broadly than to physicians only. Feedback from the industry reflects concern over expansion of the target audience because the proposal would require sending DHCP letters to physicians, nurses, pharmacists and other prescribing and non-prescribing providers. 78 FR 41065 (July 9, 2013). According to the FDA, however, the regulation currently requires manufacturers to mail important information to “physicians and others responsible for patient care.” See 21 C.F.R. § 200.5 (2011).
The agency explains that the proposed change “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.” 78 FR 41065 (July 9, 2013).
Comments are due by August 8, 2013
The Guidance was submitted to the U.S. Office of Management and Budget for review and clearance. Stakeholders may submit comments to the FDA’s revised recommendations on or before August 8, 2013. Additional information about the Guidance, including the FDA’s initial notice, is available here.