FDA Issues Revised Draft Reprints Guidance

by Ropes & Gray LLP
Contact

On February 28, 2014, the Food and Drug Administration (“FDA”) released a revised draft guidance for industry entitled Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“Revised Reprints Guidance”).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 guidanceGood 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 entitledResponding 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).

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.

© Ropes & Gray LLP | Attorney Advertising

Written by:

Ropes & Gray LLP
Contact
more
less

Ropes & Gray LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.