United States: Fireworks For Animal Compounding And More At ACI's Inaugural Animal Health And Veterinary Drugs And Therapeutics Conference-Part One Of Two

Last Updated: October 1 2015
Article by Brian J. Malkin

On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference  in New York City. The Conference featured two workshops: a pre-conference overview and a post-conference session working with FDA, the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), which included a mock meeting with the FDA's Center for Veterinary Medicine (CVM).

Kicking off the main conference were Dr. Kent McClure, General Counsel, Animal Health Institute, and Clinton Vranian, General Counsel, North America, Elanco Animal Health. Vranian provided an overview of the history of animal health products including how there were historically few "ready-made" products, where veterinarians could operate and own their own pharmacies to fill the pharmaceutical needs for animals. In addition, unlike human medicines, there has been no third-party payor model (resale only). At the heart of treatment models for animals is the veterinary client patient relationship ("VCPR"), linking animal prescription products for exclusive distribution practices. Every year, an act similar to the Fairness to Pet Owners Act of 2015 is introduced but not passed that aims to require veterinarians to write prescriptions, even if they fill them in their own offices, except while delivering acute care. The Federal Trade Commission, Vranian explained, has expressed interest in the mergers and acquisition movement in the animal health industry, which is "evolving naturally" and including more competition and with startups across all product lines and categories, which he thought should not be compared to the single class of contact lenses (a common comparison model).

McClure addressed how animal welfare and animal rights get blurred, where the goal is to look for proper care and responsible use of animals in research, as well as appropriate compensation for companion animals harmed in negligence cases. McClure noted the increasing perceived issue concerning antibiotic use in animals, as well as the impact and proper use of animal compounding, particularly when compounded from bulk active ingredients, alongside the growing animal pharmaceutical industry.

Next, Gregory Helzer, Partner, McDermott Will & Emery LLP, looked at consolidation in the animal health industry. Heltzer noted that there tends to be very detailed analyses for animal health transactions when challenged, which is generally when a market has a smaller ratio of players. In general, Helzer noted more aggressive antitrust enforcement in the current administration, where both onlabel and offlabel uses of products have been considered.

What followed was a general overview of the approval process for animal medicines by Ann Donoghue, DVM, MS, Donoghue Consulting, LLC; Dr. Gareth Harris, AVP, Global Regulatory Affairs, Merck Animal Health, and Jennifer Spokes Johansson, J.D., Senior Vice President, Regulatory Policy and Counsel, Putney, Inc. and Chair, Generic Animal Drug Alliance (GADA). Johansson noted that some suitability petitions for generic animal drugs have been harder to get than others, e.g., the change from a suspension to a tablet is often difficult to obtain via this route. She also noted that since the 1988 statutory provisions were enacted, FDA has offered no guidance for hybrid applications that are similar to 505(b)(2) NDAs. Donoghue described how FDA has been using its conditional approval process (conditional new animal drug applications ("cNADAs"), which requires a complete pivotal efficacy study within 5 years of cNADA approval, and had been a popular program. While there is an indexing process that utilizes a qualified expert panel for drugs intended for animal species too rare or varied to be used in traditional safety and effectiveness process, the process has been infrequently used (about only 10 products) e.g., fish, rodents, ferrets, or raptors. Finally, pesticides may be regulated by EPA or FDA, depending on federal and state laws, which often involves a risk assessment. Harris explained how biologics are regulated by USDA or FDA.

Following lunch, an explosive panel addressed the contentious issues surrounding drug compounding for animal medicines. Brian Malkin, Senior Counsel, McGuireWoods LLP, moderated and delievered an overview of FDA's regulation of animal drug compounding, with Rachael Pontikes, Partner, Duane Morris LLP, providing the view of animal compounders, and Theodore Sullivan, Counsel, Buchanan Ingersoll & Rooney PC, providing the view of the animal pharmaceutical industry including GADA. What became clear from the debate is that animal compounders believe that they fill a valuable void for customized medicines that need to be developed for the diversity of animal species and sizes, whereas pharmaceutical manufacturers believe that compounders go too far, competing with approved animal medicines. Caught in the middle is FDA, which has been attempting to regulate animal drug compounding without clear statutory authority in some cases, where it has sought to use guidances and test cases as a bridge rather than regulations.

Then the concept of a "patent thicket," coined by panelist Dr. Judy Jarecki-Black, Esq., Global Head, Intellectual Property, Merial, was then explored in the context of veterinary medicines. The panel compared veterinary patent litigations and reviews to those under the Hatch-Waxman Act, finding similarities and differences. While there have been statutory modifications to the Hatch-Waxman Act since 1984, including such refinements as certifying to patent listings, for animal drugs the procedures have remained largely the same since the 1988 statutory provisions. For example, FDA simply lists patents submitted by reference listed product holders in the Green Book (FDA Approved Animal Drug Products) without such certifications. And the safe harbor provisions for patent infringement include a curious carve-out for biologic veterinary products, the panel noted.

Other discussions in the first day included animal medicine trademarks and trade names, as well as the relationship between veterinary medicines, animal feed, and pet food.

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.

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
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.


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.

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.


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.


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.