United States: The Value Of A Letter: The Importance Of Dear Doctor Letters

Last Updated: February 6 2014
Article by Meta C. Danzey

Dear Colleagues and Friends,

With email, cell phones, text messages, and social media, writing letters has become a thing of the past. For drug manufacturers (and the lawyers who represent them), however, it is the very act of letter writing that may help avoid liability in a lawsuit regarding an alleged failure to warn. This letter/review highlights the importance of the form and, especially, the timeliness of Dear Doctor letters. So, before you chuck your letter writing skills (i.e., inside address, greeting, body, complimentary close, and signature), note the information below.

Requirements and Guidance for Dear Doctor Letters

According to the U.S. Food and Drug Administration (FDA), Dear Healthcare Professional letters (also known as Dear Doctor letters) are pieces of correspondence mailed from a pharmaceutical product manufacturer or distributor to physicians and other healthcare professionals to convey important product safety information. 1 The federal regulation that governs Dear Doctor letters, in part, provides:

21 C.F.R. § 200.5 – Mailing of important information about drugs.

Manufacturers and distributors of drugs and the Food and Drug Administration occasionally are required to mail important information about drugs to physicians and others responsible for patient care. In the public interest, such mail should be distinctive in appearance so that it will be promptly recognized and read. The Food and Drug Administration will make such mailings in accordance with the specifications set forth in this section. Manufacturers and distributors of drugs are asked to make such mailings as prescribed by this section and not to use the distinctive envelopes for ordinary mail. The regulation goes on to set forth certain requirements dependent on whether the Dear Doctor letter is intended to convey new information about: 1) a significant hazard to health; 2) important changes in the package labeling; or 3) a correction in product advertising or labeling.2 Additionally, the regulation specifies the proper form for Dear Doctor letters to include placement of the drug manufacturer's name and address, the font type and size, etc.3 The regulation itself is concise, but the FDA also issued a guidance to assist industry and FDA staff to "improv[e] communication of important safety information" in Dear Doctor letters.4

Although the FDA's guidance contains suggestions and "should be viewed only as recommendations" instead of requirements, any pharmaceutical manufacturer that intends to send a Dear Doctor letter should become familiar with the FDA's guidance on the subject.5 Moreover, the pharmaceutical manufacturer should actually work with the FDA to prepare the Dear Doctor letter prior to engaging in any mass mailing.6 Indeed, the FDA actually "believes that effective communication of important new information in Dear Healthcare Provider letters can be best accomplished if FDA and the manufacturer work together" on such letters.7 The guidance further provides that "FDA encourages manufacturers to consult with the appropriate review division in the development of a Dear Healthcare Provider 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."8 Working with the FDA on Dear Doctor letters provides an opportunity for the FDA to have input on the content of the letter, and manufacturers who do so may include a statement in the heading or in the body of the letter indicating that the FDA reviewed and agreed with the contents of the letter.9 Most pharmaceutical manufacturers and lawyers understand that compliance with the FDA's guidance and requirements does not necessarily shield one from litigation, but consultation with the FDA is also particularly important to "avoid the need to send a corrective letter in the event that FDA determines [...] that the content of the letter was somehow false or misleading."10

The Importance of a Timely Dear Doctor Letter

While the form and content of Dear Doctor letters are important, the Tietz v. Abbott Laboratories, Inc., Illinois state court case indicates the importance of timely sending the letters.11 The Tietz plaintiff alleged that Abbott, the manufacturer of a prescription immunosuppressant medication Humira®, failed to warn consumers or physicians that Humira could cause a rare infection known as histoplasmosis.12 The Tietz plaintiff specifically alleged that his wife suffered from the rare infection as a result of using Humira, and physicians were unable to diagnose the condition for weeks due to Abbott's failure to warn.13 Abbott submitted evidence that it had, in fact, mailed Dear Doctor letters advising of the rare infection in May 2010.14 The Tietz plaintiff argued, however, that his wife had already been hospitalized for 10 days before Abbott distributed the letters.15 Further, the Tietz plaintiff argued that the FDA had previously advised Abbott and other manufacturers — in September 2008 — to provide new information about the risks of the rare disease.16 In other words, the Tietz plaintiff argued that Abbott's Dear Doctor letter advising of the risk was "too little, too late," and apparently the jury agreed, as it awarded a $2.2 million verdict.17

In the Tietz case, the manufacturer had mailed a Dear Doctor letter advising of the risk at issue but to no avail. In fact, the manufacturer submitted evidence that it worked with the FDA to secure approval of the contents of the letter (i.e., the manufacturer had complied with the FDA's guidance). The manufacturer's arguments were insufficient to overcome plaintiff 's failure to warn allegation as the jury found that the Dear Doctor letter had not been sent in a timely manner. A cynical person may read the Tietz case and conclude that working with the FDA to mail a Dear Doctor letter lacks any value and is a complete waste of time. Any such way of thinking, however, seems to miss the point of the Tietz case. So, what is the point? The Tietz case seems to suggest that a Dear Doctor letter must be mailed within a timely period after a manufacturer learns of new safety information that should be shared with prescribing physicians and other healthcare providers. What remains unclear, however, is what period of time makes a Dear Doctor letter timely? Unfortunately, the answer is not in this letter, nor is it in the FDA's guidance, as the FDA only suggests "it is important to communicate new information promptly to healthcare practitioners involved in prescribing or dispensing a drug, or in care for patients who receive a drug."18

Other Cases re Timeliness of Dear Doctor Letters

Although the Tietz case and, more importantly, the FDA's guidance are silent on the time period that renders a Dear Doctor letter timely and prompt, a review of the case law reveals that the question is one for the jury. For example, in Rutz v. Novartis Pharmaceuticals Corp., the Rutz plaintiff alleged that the defendant manufacturer of a cancer medication failed to warn about the risk of osteonecrosis of the jaw (ONJ) in a timely manner.19 Specifically, the Rutz plaintiff alleged that the defendant manufacturer waited 10 months after receipt of the first ONJ-related adverse event to notify the FDA of its intent to revise the product labeling to reflect reports of ONJ with the use of its product.20 Further, the Rutz plaintiff alleged that the defendant manufacturer waited 22 months before sending Dear Doctor letters to notify prescribing physicians of the label change.21 The defendant manufacturer submitted evidence that it had received the first ONJ-related adverse event nearly six months after the Rutz plaintiff began using its product, and it voluntarily changed the product warnings to reflect the risk of ONJ once it had collected adequate data.22 Plaintiff submitted, however, that the defendant manufacturer "knew about the risk of ONJ long before it amended its warning and sent the letters notifying doctors of the risk."23 The court found that the issues of adequacy and timeliness of the defendant manufacturer's Dear Doctor letter and revised warnings were questions of fact for the jury.24

In Winters and Baldwin v. Novartis Pharmaceuticals Corp., the Baldwin plaintiff also alleged that the defendant manufacturer of a cancer medication failed to warn about the risk of ONJ in a timely manner.25 Specifically, the Baldwin plaintiff presented evidence that the defendant manufacturer "was slow to respond to an obvious prob lem and arguably tried to conceal or delay information concerning the risk of developing ONJ from the medical community and the public."26 The Baldwin plaintiff began using the product at issue in July 2003; however, the defendant manufacturer had been notified of the risk of ONJ with the use of its product in June 2003 and instructed members of its sales force not to mention the risk as early as August 2003.27 Although the defendant manufacturer changed the package insert to mention cases of ONJ in December 2003, it failed to send Dear Doctor letters until September 2004.28 Further, by that time, the Baldwin plaintiff had been using the product at issue for 14 months and had lost two teeth.29 The Baldwin plaintiff argued the "warnings were both insufficient and too late," and the jury agreed by returning a verdict for $225,000 on the failure to warn claim.30

A Medtronic multidistrict litigation (MDL) plaintiff made similar allegations against the manufacturer of implantable defibrillators for failure to warn in a timely manner.31 Evidence was presented that the defendant manufacturer learned in early 2003 that its defibrillators had a defective battery that caused the products to lose charge in days instead of years.32 The defendant manufacturer began receiving reports of premature battery depletion around February 2004, and it had received several reports by December 2004.33 In February 2005, which was two years after first learning of the issue, the manufacturer mailed Dear Doctor letters advising of the risk of battery depletion and product failure.34 The court found the evidence sufficient enough for a jury to determine whether the defendant manufacturer knew of the defect for a substantial period prior to advising of the defect.35


This letter serves as a friendly reminder of the value of Dear Doctor letters. In addition to providing valuable information to prescribers and other healthcare providers, Dear Doctor letters can help shield a manufacturer from failure to warn litigation. If case law is any indication, though, the timeliness of a Dear Doctor letter is as equally important as the contents of the letter. While there is no set amount of time to render a Dear Doctor letter timely, there is no time like the present to brush up on the case law and FDA's guidance and requirements for such letters to avoid a costly rewrite of the Tietz case.


1 Manual of Policies and Procedures 6020.10 "NDAs: 'Dear Health Care Professional' Letters," July 2003, at 2. .

2 21 C.F.R. § 200.5.

3 Id.

4 FDA's Guidance for Industry and FDA Staff: Dear Health Care Provider Letters: Improving Communication of Important Safety Information, November 2010. (Referenced in subsequent notes herein as "Guidance.") .

5 Guidance at 1.

6 Per the FDA's Guidance, those intending to distribute Dear Doctor letters electronically should also consult the FDA's Guidance for Industry on Using Electronic Means to Distribute Certain Product Information. Guidance at 5. See also .

7 Guidance at 2.

8 Id.

9 Guidance at 5.

10 Guidance at 2.

11 Milton Tietz et al. v. Abbott Laboratories, et al., No. 12-L-002715, Ill. Cir. Cook Co. (May 2013).

12 See .

13 Id.

14 Id.

15 Id.

16 Id.

17 Id.

18 Guidance at 2. Emphasis added.

19 Rutz v. Novartis Pharmaceuticals Corp., No. 12-CV-0026-MJR, 2012 U.S. Dist. LEXIS 177779 (S.D. Ill. Dec. 17, 2012).

20 Id. at *15.

21 Id.

22 Id. at *12.

23 Id. at *13.

24 Id. at *15.

25 Winter and Baldwin v. Novartis Pharmaceuticals Corp., 882 F.Supp.2d 1113 (W.D. Mo. Aug. 3, 2012).

26 Id. at 1118.

27 Id.

28 Id. at 1119.

29 Id. at 1120.

30 Id. at 1116, 1120.

31 In re Medtronic, Inc., Implantable Defibrillators Litigation, 465 F.Supp.2d 886 (D. Minn. Nov. 28, 2006).

32 Id. at 889.

33 Id. at 890.

34 Id.

35 Id. at 897.

Originally published in Pro Te: Solutio - Vol. 6 No. 4 November 2013

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions