Summary of FDA’s Final Guidance on Dear Health Care Provider Letters

more+
less-
more+
less-

At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a mass mailing from the FDA or a manufacturer of a drug, intended to alert health care providers about important new or updated drug information. The guidance was prompted by evaluations of DHCP letters, which have shown that there is a strong correlation between the quality of a DHCP letter and the extent to which physicians perceived the new information as important. The FDA therefore issued guidance providing specific recommendations to help improve the effectiveness of DHCP letters.

The guidance first encourages manufacturers to consult with the appropriate review division during the development of a DHCP letter to ensure that the letter clearly and accurately reflects both the manufacturers’ and FDA’s understanding of the issue and action required. Generally, DHCP letters are issued to notify health care providers about important new or updated drug information. The information can relate to: a safety concern that could affect the decision to use a drug, a necessary change in behavior by health care providers or patients, information on how to improve the effectiveness of a drug, or a correction of misleading drug information in advertising. There are three distinct types of DHCP letters: 1) Important Drug Warning Letters; 2) Important Prescribing Information Letters; and 3) Important Correction of Drug Information Letters.

Overall, each of the three types of letters should be clear, concise and contain sufficient detail to meaningfully inform the target audience. The FDA emphasizes that the first step is directing the communication to all the necessary parties: health care providers who are likely to prescribe, dispense or administer the drug, as well as any other parties who need to know the information. The guidance further states specific content that should be present on the envelope, letter heading and subject line. Within the body of the letter, the author should summarize information essential to a health care provider’s understanding of the nature and management of the problem and necessary actions to address the issue. If helpful, interior paragraphs can also provide additional detail to aid in understanding the issue, such as a summary of the data that is the basis for the new safety warning. Each type of DHCP letter should close with a paragraph detailing the drug company’s and the FDA’s contact information. For further reference, full prescribing information should be enclosed in the letter. Last, the guidance provides that manufacturers should conduct an evaluation, for their own use, determining the extent to which the target audience received the DHCP letter and is aware of the information in the letter.

You can find the entire FDA Guidance on Dear Health Care Provider Letters, including model letters, at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM233769.pdf

- See more at: http://www.swlaw.com/blog/product-liability-update/2014/04/23/summary-of-fdas-final-guidance-on-dear-health-care-provider-letters/#sthash.jShlGpZE.dpuf

At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a mass mailing from the FDA or a manufacturer of a drug, intended to alert health care providers about important new or updated drug information. The guidance was prompted by evaluations of DHCP letters, which have shown that there is a strong correlation between the quality of a DHCP letter and the extent to which physicians perceived the new information as important. The FDA therefore issued guidance providing specific recommendations to help improve the effectiveness of DHCP letters.

The guidance first encourages manufacturers to consult with the appropriate review division during the development of a DHCP letter to ensure that the letter clearly and accurately reflects both the manufacturers’ and FDA’s understanding of the issue and action required. Generally, DHCP letters are issued to notify health care providers about important new or updated drug information. The information can relate to: a safety concern that could affect the decision to use a drug, a necessary change in behavior by health care providers or patients, information on how to improve the effectiveness of a drug, or a correction of misleading drug information in advertising. There are three distinct types of DHCP letters: 1) Important Drug Warning Letters; 2) Important Prescribing Information Letters; and 3) Important Correction of Drug Information Letters.

Overall, each of the three types of letters should be clear, concise and contain sufficient detail to meaningfully inform the target audience. The FDA emphasizes that the first step is directing the communication to all the necessary parties: health care providers who are likely to prescribe, dispense or administer the drug, as well as any other parties who need to know the information. The guidance further states specific content that should be present on the envelope, letter heading and subject line. Within the body of the letter, the author should summarize information essential to a health care provider’s understanding of the nature and management of the problem and necessary actions to address the issue. If helpful, interior paragraphs can also provide additional detail to aid in understanding the issue, such as a summary of the data that is the basis for the new safety warning. Each type of DHCP letter should close with a paragraph detailing the drug company’s and the FDA’s contact information. For further reference, full prescribing information should be enclosed in the letter. Last, the guidance provides that manufacturers should conduct an evaluation, for their own use, determining the extent to which the target audience received the DHCP letter and is aware of the information in the letter.

You can find the entire FDA Guidance on Dear Health Care Provider Letters, including model letters, at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM233769.pdf

 

Topics:  Drug Manufacturers, FDA, Healthcare

Published In: Administrative Agency Updates, Health Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Snell & Wilmer | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »