United States: Goodbye To Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to "create parity" between brand-name and generic manufacturers for their labeling obligations. 78 Fed. Reg. 67985 (proposed Nov. 13, 2013).


The proposed rule directly responds to Justice Thomas's declaration, for the majority in PLIVA v. Mensing, that the Supreme Court "will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme. As always, Congress and the FDA retain the authority to change the law and regulations if they so desire." PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2852 (2011).

In the two and a half years since that landmark decision, parties have attempted to avoid Mensing in creative ways. For example, plaintiffs have attempted to limit Mensing's preemptive scope1 or argued that brand-name manufacturers should be liable when plaintiffs took the generic.2 And in April 2012, Senator Patrick Leahy (D-VT) introduced a bill to eliminate disparity between brand-name and generic manufacturers with regard to labeling responsibilities—with no success (as we predicted3).

Finally, in January 2013, the FDA quietly showed its intentions in a footnote to the Solicitor General's brief in Mutual Pharm. Co. v. Bartlett. "This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers." Ten months later, the proposed regulatory changes are here.


Under the proposed rule, holders of abbreviated new drug applications (ANDAs) would be permitted to update product labeling with new safety information even if the revised labeling differs from the reference listed drug (RLD). The updated product labeling would be submitted as a "changes being effected" (CBE-0) supplement, which permits the ANDA holder to distribute the revised label at the same time it submits the changes to the FDA. In addition, the ANDA holder would be required to send notice to the new drug application (NDA) holder, along with the information forming the basis for the revision. The proposed rule creates an exception to the current regulatory scheme under which approval for an ANDA may be withdrawn by the FDA if the labeling differs from the RLD.

The proposed rule suggests that after receiving notification from an ANDA holder, the NDA holder is "expected" to submit a revised label to the FDA and share its views as to whether the CBE-0 supplement should be approved. The FDA would then evaluate the various proposed labels and determine which label should be approved. Once a label revision is approved, ANDA holders have only 30 days to update their labels electronically via the CBE-0 process, followed by "timely distribution of drug product accompanied by an updated package insert as soon as feasible thereafter or at the time of next printing of the product labeling for packaging."


Concerns over product liability exposure could turn the CBE-0 revision process into a cacophony of competing and conflicting CBE-0 revisions as companies strive to stay ahead of failure-to-warn claims. If multiple labels are in effect at a given time, both generic and brand-name manufacturers would face increased exposure for failure-to-warn claims and be required to defend not only their own CBE-0 submission but also explain why other submissions were not adopted or incorporated. The 30-day window in which ANDA holders must update their labels will also open the door to "failure-to-update" claims. And brand-name manufacturers' post-marketing surveillance burdens will increase as they will be required to evaluate CBE-0 submissions from all ANDA holders (which is not accounted for in the FDA's burden estimates).


While the FDA has clearly made an effort to "create parity among application holders with respect to" certain labeling changes, implementation of the rule in its current form could very quickly lead to confusion. Multiple companies would be permitted to submit different labeling changes based on different information, with the NDA holder (if one still exists) responsible for evaluating the competing labels and submitting yet another proposal to the FDA.

Having laid the groundwork for confusion over what the "most" current label may be, the FDA proposes to address this confusion by dedicating a website to CBE-0 label changes. Concerned members of the public, including healthcare providers who might otherwise rely on their Physicians' Desk Reference as a reliable, easy-to-access source for product information, can "subscribe to FDA's free email subscription service to receive an email message each time there is an update to this proposed FDA Web page." Healthcare providers might then be left to sort through numerous differing label changes to determine what the most current label actually "is."

Yet the FDA insists that "concerns related to temporary differences in labeling between generic drugs and their RLDs are outweighed by the benefit to the public health that would result from all application holders having the ability to independently update drug product labeling to reflect newly acquired information regarding important drug safety issues through CBE-0 labeling supplements."


As with any proposed rule, the Agency welcomes comments. Implementation of this rule will significantly impact the entire pharmaceutical industry and, as a result, patient safety. We urge all affected parties to submit comments at http://www.regulations.gov, identified with Docket No. FDA-2013-N-0500. We hope the proposed rule undergoes substantial revisions before the FDA publishes its final rule. However, the FDA will need intelligent guidance in order to achieve its goal of improving "communication of important safety information to prescribing health care providers and the public" without sowing confusion and chaos.


1 See "Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements," Morrison & Foerster Client Alert (Jan. 14, 2013), available at http://www.mofo.com/files/Uploads/Images/130114-Buckman-Preemption.pdf; "Mind the Gap: Sixth Circuit Finds Room for Suit Against Generic Manufacturers After Mensing," Morrison & Foerster Client Alert (Mar. 14, 2013), available at http://www.mofo.com/files/Uploads/Images/130314-Generic-Manufacturers-After-Mensing.pdf.

2 See "Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs," Morrison & Foerster Client Alert (Jan. 16, 2013), available at http://www.mofo.com/files/Uploads/Images/130116-Liability-for-Generic-Drugs.pdf.

3 See "Bill to Undo Mensing Decision and Allow Patients to Sue Generic Drug Makers for Failure to Warn," Morrison & Foerster Client Alert (Apr. 19, 2012), available at http://www.mofo.com/files/Uploads/Images/120419-Mensing-Decision.pdf.

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.

© Morrison & Foerster LLP. All rights reserved

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.

Erin M. Bosman
Julie Y. Park
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