United States: FDA Issues Revised Draft Reprints Guidance

On February 28, 2014, the Food and Drug Administration ("FDA") released a revised draft guidance for industry entitled "Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices" ("Revised Reprints Guidance"). In the March 3, 2014, Federal Register notice announcing the availability of the Revised Reprints Guidance, FDA noted that comments are due on May 2, 2014.

The Revised Reprints Guidance proposes changes to FDA's January 2009 final guidance"Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices." ("2009 Guidance"). Both the 2009 Guidance and its new revision address the practices a manufacturer should follow when distributing scientific and medical publications to health care professionals that include information on unapproved new uses (i.e., "off-label uses") for an approved or cleared product. While many of the concepts set forth in the 2009 Guidance remain as to journal reprints, the Revised Reprints Guidance provides distinct treatment for dissemination of reference texts and, importantly, adds specific recommendations for the distribution of "clinical practice guidelines ("CPGs"),[1] which were not addressed at all in the 2009 Guidance. 

FDA explicitly indicated that the Revised Reprints Guidance is in direct response to two pending citizen petitions[2] filed by members of the Medical Information Working Group (MIWG), an ad hoc coalition of drug and device manufacturers to which Ropes & Gray LLP serves as one of the outside counsel. Further, as discussed below, FDA's Federal Register notice states that the agency will continue to address other requests set forth in the MIWG's citizen petitions.

I. Key Changes in the Revised Reprints Guidance

While the Revised Reprints Guidance indicates some additional regulatory flexibility by permitting the distribution of CPGs, other key changes suggest that FDA is looking to restrict certain reprint distribution practices. Below we describe the important features of the Revised Reprints Guidance.

  • Allowance of CPG Distribution: In contrast to the 2009 Guidance, which is silent on the subject, the Revised Reprints Guidance expressly allows manufacturers to distribute CPGs that include information on off-label uses for approved or cleared products. FDA would allow distribution of only those CPGs that incorporate the Institute of Medicine's (IOM's) standards for "trustworthiness"[3] and thus are aimed at ensuring that CPGs are informed by a "systematic review of evidence" and an assessment of the benefits and risks of "alternative care options." Like the requirements for other scientific and medical publications from the 2009 Guidance, CPGs would have to be accompanied by standard disclaimers as to risks of off-label uses, along with financial disclosures related to any of the CPG authors, and relevant context and bibliographic information.
  • Distribution of CPGs and Reference Texts in Their Entirety or Individual Sections: While the Revised Reprints Guidance retains the requirement that a journal article should be distributed only in an "unabridged" form, it expressly allows the distribution of CPGs and reference texts either in their entirety or in individual sections (e.g., chapters) that include information on unapproved uses. If a manufacturer chooses to distribute an individual section of a text or CPG, it must be the complete, unabridged section. Further, the Revised Reprints Guidance provides that a CPG addressing one disease state, rather than multiple disease states, should be disseminated only in its entirety.
  • Meta-Analysis and Non-Clinical Research Information Limited to Medical Device Reprints: The 2009 Guidance permits distribution of reprints and texts that "address adequate and well-controlled clinical investigations," including historically controlled studies, pharmacokinetic ("PK") and pharmacodynamic ("PD") studies and meta-analyses of a specific clinical hypothesis, without any distinction between medical device and drug reprint practices. The Revised Reprints Guidance draws such a distinction. Drug reprints are limited to information that addresses adequate and well-controlled studies, whereas device reprints also can discuss "significant investigations other than adequate and well-controlled studies, such as meta-analyses, if they are testing a specific clinical hypothesis" and "significant non-clinical research (such as well-designed bench or animal studies)." As currently written, the Revised Reprints Guidance implies that drug manufacturers cannot distribute reprints discussing meta-analyses, PK or PD studies and other significant non-clinical research.

II. Impact of MIWG Petitions on FDA's Regulation of Manufacturer Communications

In addition to announcing the availability of the Revised Reprints Guidance, FDA's Federal Register notice explains that the agency is continuing to consider the specific requests set forth in the MIWG's pending citizen petitions. Specifically, in July 2011, seven MIWG member companies filed a citizen petition requesting FDA to clarify its regulatory approach to four types of manufacturer communications about off-label uses: (1) responses to unsolicited requests; (2) scientific exchange; (3) communications with formulary committees and payors; and (4) the dissemination of third-party CPGs. In response, on December 28, 2011, FDA issued a draft guidance entitled"Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices"  and opened a public docket on the concept of "scientific exchange." In September 2013, MIWG filed a second citizen petition requesting FDA to respond fully to all four requests in the July 2011 petition and further requesting FDA to undertake a comprehensive review and modification of its entire regulatory approach to manufacturer communications, particularly in light of three recent cases[4] highlighting the constitutional and statutory limitations of FDA's regulatory authority.

The Federal Register notice acknowledged that the agency has not yet reached a final determination on the issues presented in the MIWG's citizen petitions. But the notice indicated FDA intends to address a number of those issues. For example, the Federal Register notice explicitly lays out FDA's responses to-date regarding some of the issues raised in MIWG's citizen petitions, including (1) creating a public docket to solicit public input on the concept of scientific exchange; (2) considering comments on the 2011 unsolicited requests draft guidance and (3) considering draft guidance on industry interactions with formulary committees and payors, including presentation of health care economic information. Both the notice and the Revised Reprints Guidance, however, were silent on recent First Amendment case law and its potential impact on FDA regulation. 

It remains to be seen whether any regulatory changes made by FDA will result in additional flexibility or additional scrutiny over manufacturer communications regarding truthful, non-misleading information about unapproved uses for approved or cleared products.


[1] The Revised Reprints Guidance defines CPGs as statements that include recommendations intended to help clinicians make decisions for individual patient care, including in circumstances where there are few or no approved drugs or devices indicated for the patient's condition or the approved therapies have not proven successful for the individual."

[2] See July 2011 Citizen Petition FDA-2011-P-0512; September 2013 Citizen Petition FDA-2013-P- 1079.

[3] FDA clarifies that standards for CPG "trustworthiness," incorporated in the Revised Reprints Guidance, are taken directly from IOM's Congressionally mandated study that focused on "the best methods used in developing clinical practice guidelines in order to ensure that organizations developing such guidelines have information on approaches that are objective, scientifically valid, and consistent," results of which are set forth in its report, Robin Graham, et al., Institute of Medicine of the National Academies, Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, Clinical Practice Guidelines We Can Trust (2011).

[4] See Sorrell v. IMS Health, Inc.,131 S. Ct. 2653 (2011); FCC v. Fox Television Stations, 132 S. Ct. 2307 (2012); United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

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.

Authors
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
Drinker Biddle & Reath LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
Drinker Biddle & Reath LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

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