Lester M. Crawford, D.V.M., Ph.D.- Third Conference on Int'l Harmonization

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
Third Conference on International Harmonization
of Veterinary Medicinal Products
Washington, D.C.

Remarks by
Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drugs

May 26, 2005

 

Good Morning. Thank you, Rick (Dr. Richard Hill, USDA, APHIS, Center for Veterinary Biologics) for your kind introduction. I’m honored to be here this morning to help open the third international meeting of the International Conference on Harmonization of Technical Requirements for Veterinary Medicinal Products (VICH). I also want to echo Dr. Hill’s welcome to all of our international guests.

As a veterinarian, I certainly know the importance of having safe and effective medicinal products available to treat sick or dying animals. It’s frustrating for the animal owner and the veterinarian to see an animal suffer and die because the appropriate treatments to combat disease or injury were not available.

Some of you may know that I started my career with FDA in the Center for Veterinary Medicine where I learned first hand about the animal drug approval process. I also spent time early in my career working in the animal health industry, so I can appreciate both perspectives on the concerns and complexities of bringing animal health products to the market place. Obviously, these concerns and complexities are only heightened when every country has different requirements for determining the safety and efficacy of these products. In my present position as the head of FDA, I have an even broader perspective on the importance of the animal health industry.

Through all my experiences, beginning as a veterinarian, and extending to FDA’s Office of the Commissioner, one concept is crystal clear. The existence and viability of the animal drug industry is very important and we cannot minimize its value. We need an animal health industry to invest in the discovery, development and marketing of animal medicinal products. It is vital not only to the health of our food animals, companion animals and wildlife, but also to the public health. Animal health, and by extension public health, will benefit from increasing veterinary access to new treatments and products.

FDA can enhance the animal drug approval process – without any reduction in standards for safety and effectiveness. In fact we have already accomplished much in this area. We will continue to scrutinize the review process and improve its efficiency and effectiveness. But, there is no question that today we live in a truly global society. Through harmonization, we have a tremendous potential to speed development and dissemination of treatments to minimize and halt animal diseases, and to prevent their spread to other regions of the world thus improving the safety of food from animals, and the public health.

Dr. Hill, my colleague from USDA, mentioned a few moments ago in his opening remarks that this third international conference of the VICH marks the closure of the first phase of the organization’s history and will focus on progress achieved and future strategies for harmonization through 2010. He also mentioned that the VICH was formally launched in April 1996.

I want to take just a few moments to mention a couple of milestones that led up to that April 1996 launch. Some of you here today may have been involved in those initial groundbreaking activities.

The initiative to begin the harmonization process for veterinary medicinal products actually began back in 1983 when the first International Technical Consultation on Veterinary Drug Registration was held. Standard requirements for veterinary product registration had already been adopted throughout Europe in 1981.

In 1991 the first International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was held in Brussels. That meeting brought together regulators and industry representatives from the US, the European Union (EU), and Japan to address quality, safety and efficacy requirements in the three regions. Just two months after that, the first in a series of meetings by the three parties was held on harmonization of veterinary biologics.

Then, in 1993, FEDESA (the European Federation of Animal Health) published its discussion document on global harmonization of standards that set out a program for the international harmonization of registration requirements for veterinary pharmaceuticals and biologics. In 1994, following a number of consultations and conferences, the Office International des Epizooties (OIE) set up an ad hoc group on harmonization of veterinary medicinal products.

It was this OIE ad hoc group that did the preparatory work for establishment of the VICH. They developed the scope of veterinary harmonization, and proposed the membership and objectives. The group decided that on the subject of food safety standards that the VICH should complement the work of Codex and the Joint Expert Consultation on Food Additives and Contaminants (JECFA), and that issues related to good laboratory practices (GLP) and good manufacturing practices (GMP), which were already the subject of mutual agreements would not normally be in the domain of the VICH.

The VICH steering committee assessed those ICH guidelines which could be adapted to the VICH program, defined in detail areas of non-harmonization between the EU, the US, and Japan, and put forward preliminary suggestions for priority topics. With this work completed, the VICH Steering committee held its first meeting in 1996 to formalize the membership and working procedures and establish the work program.

And, as they say, the rest is history!

I know you will be hearing momentarily from Herve Marion, the VICH Secretariat, about VICH processes and accomplishments, so I want to take the rest of my time with you this morning to highlight the importance of the VICH to FDA’s mission, and how the work of the VICH facilitates FDA’s priorities.

As you know, in the United States, it is the FDA that is responsible for the premarket assessment of safety and efficacy, and the monitoring of manufacturing quality of animal drugs, while my colleagues at the USDA are responsible for the safety of veterinary biologics. It is also FDA’s responsibility to protect and promote the public health. However, if we impede the flow of new veterinary medical products to the market we are not appropriately fulfilling our mission.

In this ever-shrinking world of the 21 st century, like many other industries, the animal health industry is a global business. That’s why the VICH government/industry international collaboration makes such good sense. It is a unique opportunity for government and industry from around the globe to work together on common goals.

That’s also why the work of the VICH is so important to FDA. Through VICH efforts to remove barriers internationally to the discovery, development and marketing of new veterinary medicinal products, we are able to mount a global effort to incorporate emerging science to protect animal health.

We at FDA are in the process of finalizing our long-term strategic goals for modernizing our operations. Two of these goals in particular; increasing access to innovative technologies to advance health, and improving product quality and safety through better manufacturing oversight; are greatly facilitated by the work of the VICH.

For example, as a part of FDA’s long-term strategic goal to increase access to innovative technologies to advance both human health and animal health we have three primary objectives:

 

• To increase access to safe and effective new medical products for unmet animal health needs including emerging infectious diseases, by increasing the number and quality of marketing applications,
  
• To increase the number of safe and effective new animal medicinal products by increasing the predictability, efficiency, and effectiveness of product development, and
  
• To sustain access to safe and effective new animal medicinal products by providing rapid, transparent and predictable review of marketing applications.
  

Our strategic long-term goal of improving product quality and safety through better manufacturing has two major objectives;

 

• To maximize medical product quality and food safety through improved manufacturing practices using new scientific and technical standards and systems, and
  
• To minimize harm from low-quality, unsafe products by increasing the likelihood of detection and interception of substandard processes and products through efficient risk management, external partnering and collaboration.

The VICH particularly informs these FDA objectives through their Expert Working Groups on Quality, Safety, Ecotoxicity, Good Clinical Practice, and Efficacy Requirements for Anthelmintics. The efforts of the Expert Working Group on Pharmacovigilance regarding a common veterinary pharmacovigilance framework and terminology, and electronic standards for the transfer of information between countries is especially important for FDA and other regulatory bodies globally.

In addition, the work of the VICH Expert Group on Antimicrobial Resistance is of particular interest and importance to FDA as we review new animal health product applications with an eye towards preventing the development of microbial resistance to anti-infectives of importance in human health.

I want to assure our global partners in this activity that FDA is committed to the continued work of the VICH. We must achieve harmonized guidelines for all regulatory requirements where significant differences exist among the participating regions. We must all contribute to the global response to significant emerging issues and to the science that impacts regulatory requirements. And, it is essential that we promote consultation and communication mechanisms that result in wider international awareness and acceptance of VICH guidelines.

I also want to commend the animal health industry and my regulatory colleagues from the EU and Japan, as well as the representatives from the “Observer” countries of Canada, Australia and New Zealand for their continued support and commitment to the VICH.

This organization has accomplished much in its short history of nine years, having already developed 33 guidelines. But there is much more to be done, and I know all of you here today are going to be exploring future strategies to address many important issues. Perhaps most importantly, the potential for a common technical document that focuses on the essential scientific requirements needed for product registration.

I believe it is important to the animal health industry that as new guidelines are developed, cost/benefit analysis be included. VICH guidelines need to be both scientifically accurate and economically feasible. Existing guidelines also need to be continually monitored and updated as science advances to take advantage of new and innovative technologies.

In closing, let me just make one final point. The VICH was modeled on the ICH, which has similarly worked to harmonize registration requirements for human drugs and biologics. I think it is probably fair to say that the ICH has accomplished more than the VICH – but then, they have been working for a longer period of time.

I also want to point out that many of the FDA resources needed for the ICH have, over time, come from industry user fees that are collected by the Agency under authority of the Prescription Drug User Fee Act (PDUFA). There has been no similar source of money specifically set aside in the Agency designated for VICH work.

The accomplishments of the VICH that you will celebrate and discuss over the next two days represent the realization of very important priorities for FDA and its Center for Veterinary Medicine. To deal with today’s budgetary realities, we at the FDA will have to have a more deliberate approach to clearly identify the resources to accomplish significant new VICH initiatives.

As we move closer to the reality of electronic applications and electronic pharmacovigilance programs, development of the so-called “Common Technical Document” for applications with harmonized data fields and reporting cycles for adverse event monitoring become more urgent for all of us. Continuing this work within the unique VICH structure is an opportunity that demands our future creative collaborations.

It is important to both the animal drug industry and the regulatory agencies charged by their respective governments to provide oversight, that we make safe and effective animal medicinal products available as rapidly as possible, and that we monitor those products already on the world markets to identify any problems as rapidly as possible.

These are our mutual ideals and goals and we all have a duty to pursue them.

Thank you.