United States: Launch Of OpenFDA Increases Accessibility To Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA (https://open.fda.gov ), a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports has industry benefits, it may also put drug manufacturers at greater litigation risk. This potential exposure highlights the need to prepare adverse event reports with an eye toward avoiding admissions on causality or making other statements in the absence of complete information.

What It Includes: The June 2 launch of the openFDA website contains a searchable database of more than three million adverse drug event reports submitted by drug companies, consumers, and healthcare professionals from 2004 to 2013. These reports were previously available only through difficult-to-use reports or Freedom of Information Act requests.2

What Is Available: While the first phase of openFDA only includes data on adverse drug event reports, soon it will include datasets on product recalls and structured product labeling data. The FDA also plans to expand openFDA beyond drugs to include data on devices and foods.

How OpenFDA Works: OpenFDA is a search-based API, or application programming interface. OpenFDA users may submit a query to the API using a number of variables including brand name, generic name, pharmacologic class, route of administration, and active ingredients. Although the data available through openFDA are undoubtedly useful, the API requires users to write code to obtain search results. This process may be time-consuming and impractical for everyday consumers who wish to obtain information on a particular drug.

However, the FDA stated that the API will allow developers to build their own applications on top of openFDA.3 One such application already exists. ResearchAE.com is a web-based application that allows the public to search the FDA's data in a more streamlined fashion, without having to write code.4 The application allows users to search openFDA data by entering search parameters into fields, much like an advanced search engine. It also provides manufacturer information based on a Google search of the NDA or ANDA number associated with a particular adverse event report. Other user-friendly applications will likely use openFDA's API to provide additional access to the FDA's data.

How Industry and Academia Can Use OpenFDA: Increased access to this data will be especially useful to academic researchers and pharmaceutical companies. The ability to avoid submitting Freedom of Information Act requests or analyzing difficult-to-use reports will save researchers and pharmaceutical companies time and money. Having the data in one place in a simplified form will allow these groups to analyze adverse event reports and statistics in order to better understand the limitations and benefits of various drugs.

OpenFDA's Impact on Litigation: OpenFDA could increase litigation risk for pharmaceutical companies. Easier access to a decade's worth of adverse event reports will allow the plaintiffs' bar to mine adverse drug event data for potential claims and may lead to increased litigation filings. For pending litigation, openFDA will provide plaintiffs with access to more adverse event reports than they would be able to obtain in discovery, creating larger sample sizes on which experts can base their opinions.

OpenFDA users—and potential plaintiffs—may overlook FDA warnings about lack of established causality and draw unwarranted inferences about a causal link between the drug and the adverse event. Additionally, the public may not realize that the raw number of adverse event reports for a particular drug is not indicative of the rate or prevalence of adverse events, as adverse event data do not convey the total number of people who have taken the drug. For these reasons, increased access to adverse event report data is likely to create a perception of more risk than actually exists, which could in turn lead to more lawsuits.

How Manufacturers Can Protect Themselves: The potential for plaintiffs to use openFDA data to generate or support litigation with widely accessible information highlights the need for drug manufacturers to take great care in preparing adverse event report submissions. Manufacturers need to keep in mind the very limitations announced on openFDA: that adverse event reports "do not undergo extensive validation or verification," and that a causal link between the drug and adverse events cannot be established through an adverse event report.

With regard to validation and verification, manufacturers often submit adverse event reports based solely on information provided by the reporter, without review or analysis of underlying medical records. Accordingly, the report should clearly refer to what was "reported" rather than statements of what "occurred" based on secondhand knowledge.

Manufacturers should also be mindful that product identification may not be accurate and that the FDA does not require statements regarding causation in adverse event report submissions.5 Therefore, admissions of product identification, liability, and causation should be avoided.

While the FDA has heralded openFDA's launch as the latest tool in "promoting and protecting the public health," the increased accessibility to massive amounts of adverse event data is not all good news for the pharmaceutical industry. Instead, it should serve as a reminder that pharmaceutical companies need to carefully conduct adverse event reporting in a manner that is consistent with FDA requirements while also protecting the company from unnecessary liability.

Footnotes

1 The authors thank Brittany L. Rosentrater, a summer associate at Morrison & Foerster and student at University of San Diego School of Law, for assistance preparing this client alert.

2 http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm399335.htm .

3 http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm399335.htm .

4 http://www.researchae.com .

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.

Authors
Erin M. Bosman
Julie Y. Park
 
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
Check to state you have read and
agree to our Terms and Conditions

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.

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 by clicking here .

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.