The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP
Contact

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing what it considered to be a false and misleading professional detail ad. The promotion for a prescription pain medication, an opioid agonist, omitted risk association and failed to include the full FDA-approved indication. The devil was in the details and, well, those details were absent.

AGG Observations

  1. OPDP issued a Warning Letter. There is no indication that the agency previously raised concerns about the product promotion. OPDP is not required to first issue a Notice of Violation or Untitled Letter. 
  2. OPDP sent the Warning Letter because of, among other reasons, the lack of any information for the Boxed Warning product, and the truncating of the fully-approved indication, including the limitations of use. The product’s opioid’s status, in addition to the omission of material facts, presented a public health concern. 
  3. We have many pharmaceutical clients that market products with limitations of use in the indication. Limitations of use are part of the indication, and shortening the indication is a failure to provide complete information. Furthermore, the limitations of use, by definition, narrow the product’s use, frequently to note which patients should or should not use the drug (e.g., where alternative treatments are inadequate). So, failing to provide the full indication, which might include limitations of use, not only misleads a consumer to believe the use is broader than it is, but may also present safety risks by not disclosing the limitations and the product’s potentially dangerous use for certain patients. Therefore, it is essential that limitations of use be provided in the indication section of any marketing material. 
  4. While this should be evident, if a company provides statements about a product’s safety or efficacy, it must provide fair balance, such as risk information. In the Warning Letter at issue, OPDP said the company offered no risk information (which included serious and potentially fatal risks). This alone is unlawful. Add that the product contained a Boxed Warning (and was an opioid product), and the detail aid was a high-risk enforcement target for agency action. 
  5. In this case, OPDP issued the Warning Letter to the new drug application holder and copied the licensing partner. While the licensing partner might have been truly at fault for the messaging, the applicant was the addressee. The NDA holder is ultimately responsible for compliance. While parties may agree, through contract, to enter into a co-promotion or licensing arrangement, the agency looks to the NDA holder and, thus, that party must ensure that materials disseminated about its product are compliant. 
  6. As we see with many Warning Letters, OPDP required the company, as part of its response to provide:

    a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials. In order to clearly identify the violative promotional piece(s) and/or activity and focus on the corrective message(s), OPDP recommends that corrective piece(s) include a description of the violative promotional piece(s) and/or activity, include a summary of the violative message(s), provide information to correct each of the violative message(s), and be free of promotional claims and presentations. To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated
    (Emphasis added.)
  7. We have noted in past Bulletins and webinars that FDA has been hesitant to issue enforcement letters concerning off-label promotion, in light of past lawsuits and ever-evolving discussion. However, as we also caution, the agency will continue to take action when it sees violative promotion and, in particular, if the unlawful messaging presents public health risks. 
  8. Remember, providing FDA-required information is not optional; it is the law. Safety information is not merely nice-to-have messaging, and the details of promotional materials matter to FDA.

 

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.

© Arnall Golden Gregory LLP | Attorney Advertising

Written by:

Arnall Golden Gregory LLP
Contact
more
less

Arnall Golden Gregory 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.
Custom Email Digest
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.