United States: Dear Doctor: Big Changes Are Being Effected – The 4th Branch of Government to the Rescue of Tort Claimants

Last Updated: November 9 2013
Article by Michael A. Walsh

Today the director of the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., posted an announcement of a proposed rule illustrating that FDA will go where the United States Congress and the Supreme Court could not go. The FDA's proposed rule, entitled "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products," allows/requires "generic drug manufacturers to independently update and promptly distribute revised product labeling - just like brand name manufacturers - before FDA reviews or approves the change." 

This rule would permit the generic manufacturer to have a label that differs from that of the reference listed (or branded) drug. To avoid confusion over differing labeling, the FDA proposes to "establish a dedicated Web page (or, alternatively, to modify an existing FDA Web page) on which FDA would promptly post information regarding the labeling changes."  This is a significant departure from how labeling information is disseminated.

This proposed rule opens the door to requiring generic manufacturers to sit in the same position for labeling purposes and product liability purposes as the brand drug manufacturer. The proposed rule allows generic manufacturers to make what were known as Changes Being Effected (CBE) that now can only be made by the referenced listed (i.e. branded) drug manufacturer and to send Dr. Doctor letters informing physicians of label changes. The proposed CBE rule will require the generic manufacturer to add or strengthen information about dosage, abuse, dependence, psychological effect, or over dosage, to increase the safe use of the drug product, and to delete false, misleading, or unsupported indications for use or claims for effectiveness. It is precisely these types of claims that the Courts have recognized that generic manufacturers cannot make under the current law and which serve as the basis for dismissing thousands of product liability lawsuits. 

Under the proposed rule a generic manufacturer must make labeling changes

when new information becomes available that causes information in labeling to be inaccurate, the application holder must take steps to change the content of its labeling.  ... A drug is misbranded in violation of the FD&C Act when its labeling is false or misleading, or does not provide adequate directions for use and adequate warnings.

According to the FDA "[t]he proposed rule would create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects... from the labeling of its reference listed drug (RLD) upon submission to FDA of a "changes being effected" (CBE-0) supplement." FDA states that the reason for the new rule is:

...to remove an unnecessary impediment to prompt communication of the most important safety-related labeling changes (e.g., boxed warnings and contraindications) for drug products with labeling in the PLR format.

To implement the new rule, the FDA will now require generic manufacturers:

...to develop written procedures for the surveillance, receipt, evaluation, and reporting of post marketing adverse drug experiences to FDA.   Application holders must promptly review all adverse drug experience information obtained or otherwise received by the applicant from any source, foreign or domestic, including information derived from commercial marketing experience, post marketing clinical investigations, post marketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific papers, and comply with applicable reporting and recordkeeping requirements.

Does the FDA Have the Power to Make This Change?

The proposed rule goes on at length to establish that the FDA has the power to make this rule change, stating, among other things:

In Pliva v. Mensing, the Supreme Court recognized that "Congress and the FDA retain the authority to change the law and regulations if they so desire" Recently, in Mutual Pharmaceutical Co.,Inc. v. Bartlett, the Court indicated that "Congress' decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs' compositions or their warnings" contributed to the outcome in that case (preemption of the tort claim against the generic manufacturer). 

Congress Never Got Around To Dealing With Preemption

In Mensing the Court correctly noted that Hatch Waxman struck a balance to provide cheap, not less expensive, life-saving therapy to patients. In the aftermath of the Supreme Court holding in Mensing foreclosing failure to warn claims against generic drug manufacturers on the grounds that the generic manufacturers are powerless to make label changes, Sen. Leahy submitted a draft bill entitled the "Patient Safety and Generic Labeling Improvement Act"  to amend the Food Drug and Cosmetic Act to add to the New Drug provisions under section 505 (21 U.S.C. Sec. 355) as follows:

Notwithstanding any other provision of this chapter, the holder of an application approved under subsection (j) [ANDA] may change the 'Warnings' section of the labeling of a drug so approved in the same manner as the holder of an approved new drug application under subsection (b), unless the Secretary prescribes by rule another manner.

FDA is Coming to the Rescue of Tort Claims

Irrespective of whether Congress struck a poor balance or wasn't thinking at all about generic manufacturer liability or state law failure to warn lawsuits in enacting Hatch-Waxman, in the nearly 30 years since Hatch Waxman has been in existence, Congress has not seen fit to view this "dissimilar statutory scheme" as inconsistent with its intent by enacting legislation or to rewrite the calculus for generic drug prices. In the Supreme Court opinion in Bartlett, the dissent refers to a "dissimilar statutory scheme" as a "gap" in the federal regulations stating:

[FDA] "faces significant resource constraints that limit its ability to protect the public from dangerous drugs...[t]ort suits can fill the gaps in federal regulation by 'serving as a catalyst to identify previously unknown drug dangers..." [and] "Manufacturers who have greater 'access to information about their drugs' than the FDA retain the ultimate responsibility for the safety of the products they sell.

Whether the statutory authority granted the FDA in 21 USC 371 is sufficient for FDA to create a regulatory solution to fill the "gap" and create tort parity between Levine (where lawsuits survive against brand manufacturers) and Mensing (where lawsuits are dismissed against generic manufacturers) remains to be seen, but there is little doubt that FDA is taking the up the mantle of tort claimants and flexing its might as the Fourth Branch of Government.

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
Michael A. Walsh
 
In association with
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
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.

    Disclaimer

    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.

    Registration

    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.

    Cookies

    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.

    Links

    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.

    Mail-A-Friend

    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.

    Emails

    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 .

    Security

    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