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Comments by Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine, FDA
for the
Association of American Veterinary Medical Colleges
August 2, 2007
Bethesda, Maryland
The Food and Drug Administration’s "Critical Path" initiative is reinvigorating the field of biomedical research, making it more productive and more efficient, and creating opportunities for scientific research in academia, in the private sector, and in government.
Veterinarians are ideally suited to take advantage of those research opportunities, because veterinarians have the broadest biomedical disciplines, encompassing the entire spectrum of medical activities from the molecular to entire ecosystems.
In 2004, FDA launched its Critical Path initiative to address the problem of medical product development bottlenecks. In its report published in 2004, FDA identified the problem as the fact that "the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences." In other words, the number of medical innovations developed by researchers in companies and academia has been far outpacing the development of new, effective, affordable, and safe products for patients.
With Critical Path, FDA began an initiative for creating a new product development toolkit that includes better ways to assess a product's safety, its medical utility, and its potential for industrialization (which is a product's ability to move from the lab to the marketplace).
The 2004 report said, "Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness (the measure of medical product performance) of new products can be demonstrated in faster time frames with more certainty and at lower costs." Product sponsors in some cases have had to use last century's tools to assess potential new products. With older tools, companies may not be able to detect failures early, which is a significant problem, because the sooner a sponsor can detect products likely to fail the fewer resources will be wasted. Using resources on products that ultimately will fail also means fewer resources will be available for products that work, a situation that could potentially delay or even prevent products from getting to patients. And, without better tools to determine safety and effectiveness early, some products can get to market before the problems are uncovered.
After announcing the Critical Path program in 2004, FDA received several recommendations for projects, and grouped them into six categories:
FDA is the only organization that could successfully implement a program such as Critical Path. FDA has a unique position in biomedical research. Because it oversees evaluation of all U.S. medical products, FDA can identify the key product development hurdles that commonly delay companies trying to bring products to market. It is the only organization that can set the scientific standards for product development, so FDA is the only organization that can ensure that new Critical Path tools become the new standards for proving efficacy, assessing safety, and for safe manufacturing of medical products.
Although Critical Path is an FDA initiative, it was never designed to be an FDA-only program. Critical Path science is an applied science, and it is meant to work in partnership with the discovery science carried out by industry, academia, and other health-related organizations.
The expected outcome of Critical Path, in fact the outcome we have already seen, is an increase in the movement of new products down the pipeline from discovery to patients. Recently, FDA issued a report, the “Critical Path Opportunities Initiated During 2006,” that listed more than 40 initiatives, so the program has had a strong beginning.
The report pointed out that not all of the projects identified in the Opportunities List are for human medicine; several are in veterinary medicine. Scientific advances under Critical Path can improve the tools FDA uses to evaluate safety and effectiveness of veterinary as well as human products. The advances can help FDA determine the safety of food ingredients, through new rapid tests for biological and chemical contamination of animal-derived foods. Improved analysis technologies can be used for assessing safety and nutritive value of foods, food ingredients, and feeds. Sophisticated cross-disciplinary scientific review is necessary to appropriately assess the issues of genetic engineering and animal cloning.
In animal production, FDA sees a need for new technologies to reduce various pathogens and will need to be ready to evaluate them as they are developed. An example is the therapeutic intervention for the reduction of E. coli O157:H7 in cattle immediately prior to slaughter, which could lower human exposure to the pathogen.
We believe that, whether working for a government agency, for industry, or in academia, veterinarians can offer a great deal of scientific know-how to advance Critical Path goals.
We believe that veterinarians are uniquely trained to succeed in research. They have a broad range of biomedical training, and they often are involved in one of a large number of specialties.
Veterinary Specialty Boards and Diplomates are in the areas of:
And, while veterinarians often have in depth knowledge in one area, they also have an awareness of the bigger picture through their training, a fact acknowledged in a report, the Pew Health Professions Commission in Health America: Practitioners for 2005. In the report, Pew said: "Veterinarians are more knowledgeable about the impact of animals and diseases on human health and the role and use of animals in the improvement of health and well-being than any other health professional in most communities. Thus veterinarians should be more directly available to human health providers for consultation on these subjects."
In addition to all that, veterinarians must become resourceful and creative in problem solving, simply due to the nature of their work.
FDA employs 115 veterinarians and found that they have scientific skills that allow them to do many jobs. FDA veterinarians direct science-based programs, are involved in epidemiology, drug review, risk assessment, food safety, biosecurity, and international trade.
Approximately 90 FDA veterinarians work at CVM, where they are involved in scientific research in areas such as:
For the future, we know that pre-market evaluation of medical products must change from our current passive, empirical (trial and error) system that uses patient-exposure as a basis for assessing adverse events to a predictive evaluation, based on a "robust body of prior knowledge about the molecular or the physical mechanisms of a product," as we said in our "Critical Path Opportunities Report" released in March 2006.
Moving in that direction of predictive evaluation will require developing expertise in the new sciences, particularly:
A significant benefit to the individual veterinarian involved in biomedical research is that the experience can serve as a stepping stone to more significant, more influential positions, such as overseeing public health programs, protecting food safety, etc.
Those types of positions can be filled only by someone who has broad experience beyond just the practice of veterinary medicine. Research positions will provide that necessary experience.
Critical Path is making it possible for companies to more efficiently, effectively move products from biomedical innovation to patients, helping to keep humans and animals healthy.
As the Critical Path Initiative picks up momentum, the opportunities for those interested in biomedical research are increasing.
Veterinarians, because of their in depth knowledge of certain biomedical specialties, combined with their broad understand of biomedical science, are uniquely suited to do biomedical research. In return, meeting the challenges of biomedical research prepares veterinarians for leadership roles in government or industry in research, public health, program management, and many other areas. And many of those roles are open because of FDA's Critical Path initiative.
The time has never been better for a veterinarian to seek a position in research, and the experience can help them in their careers.
At the same time, a veterinarian might find that time spent doing research could be very rewarding personally, because it is an effort that ultimately will benefit a large number of humans and animals.