Veterinary Medicine: Future Challenges and Directions
Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD, USA.
The 2005 environment presents new challenges and opportunities for the animal pharmaceutical industry. The current regulatory and economic environment is not for the meek or tender-hearted. It requires bold new perspectives from both the pharmaceutical industry and academia to address the therapeutic and production needs of animals.
With the implementation of ADUFA, a new window of opportunity exists to reinvest in significant research and development of novel therapies and production solutions. The research and candidate selection for development has to be extremely focused and discriminating to meet the needs. The pharmaceutical companies who will be the leaders of the future are the ones who abandon current traditional business objectives and venture into new arenas.
For the last forty years, the animal pharmaceutical industry has largely relied on the sales of antibacterial and anthelmintic products as the major portion of their product portfolios. Individual firms in the food animal pharmaceutical business had one or two flagship antimicrobials for treating bovine respiratory disease, swine respiratory disease, and for the reduction of poultry mortality. To a lesser extent firms carried antimicrobials for companion animal diseases. In addition, sponsors’ portfolios contained anthelmintic molecules and a smattering of anticoccidials, intramammary and other products. Many company portfolios contained production drugs, both hormonal and non-hormonal, for weight gain and feed efficiency and predominantly indicated for cattle. On the companion animal side, firms had a few key antimicrobials, anthelmintics, heart worm preventatives and flea control products.
When concerns surfaced about the possible impact of antimicrobial use in animals affecting human health, the ability of the industry to rely on this 40 plus year old business model was shaken. Much of the research and development for new antimicrobials, especially for food-producing animals was stopped. The initial shift in the industry’s portfolios was to look at adjunctive therapies used in the treatment of disease processes such as NSAIDs as a means to focus on products that might reduce the need for antimicrobials. Some firms looked at alternative animal drug products such as competitive exclusion products, phages, and other technologies that had been shelved when antimicrobials demonstrated more reliable effectiveness. In addition, most firms moved their product development from the food animal arena to the companion animal therapeutics remaining active in the development of antimicrobials.
The days of having a flagship molecule that, once fully developed, met the financial needs of the industry has gone into history. Firms have had to seek leaner profits supporting more products with smaller markets. With increased support costs, less money is available for research and development and those funds must be used more judiciously.
The industry looked to the cost of drug regulation as a means to reduce development cost and sustain profits. Following largely the human drug model, the Animal Drug User Fee Act was passed by Congress in 2003. By paying user fees, the industry, in effect, invested in the government to become more efficient, shortening development times and thereby reducing the cost of drug development. The result is that review times have begun to shorten, potentially resulting in shorter development times. CVM and the industry have been actively working to look at the factors that result in multiple review cycles. As the review times shorten and review cycles reduce, the industry can see a substantial return on their user fee investment. For example, if a sponsor brings a $10 million product to the market place and through savings in development time, shortens the time to approval by 6 months, the firm recoups an additional $5 million, some part of which can be reinvested into new research and development.
Under the current user fee regulatory environment, firms realize higher profitability when:
- Firms are extremely prejudice in which products they develop.
- Firms have a solid business plan for developing their products.
- Firms aggressively pursue product development for those products they intend to market.
- Firms have trained their staffs to meet the regulatory requirements for data quality and scientific content.
- Firms are focused on submitting only those data and reports that have a high degree of being successfully accepted in one review cycle.
- Firms are quick to address new issues and regulatory concerns to keep product development on track.
Moreover, firms can realize higher profitably by strategically using recouped dollars to reinvest in promising products with greater levels of certainty. As these products replace the antimicrobials in the industry’s product portfolios, cash flow is not only restored but is better supported with a broader base of products.
However, a huge gap in therapeutic and production solutions exists. The gap is currently being filled to some extent by the emergence of untested and unstudied products such as nutriceutics and other nutritional supplements. Pharmacies are compounding products to meet the demand for pharmaceutical solutions. Animal owners are looking to alternative medicines to find solutions to unresolved clinical problems in their animals. And unfortunately, in too many instances, the snake oil salesmen emerge. The various therapies are filling gaps that could be and should be filled by proven pharmaceutical solutions.
As a result of the industry’s shift to companion animal medicine as a growth market have come some exciting new therapies. Most of these were largely borrowed or expanded from human medicine for treatment of congestive heart failure and other important diseases. As the human population ages and drug development moves toward meeting the therapeutic needs of the middle aged and geriatrics, so does the crossover development for companion animals.
The animal drug industry is quite diverse. Some sponsors own very old pharmaceuticals and have no intention of starting a research and development program. These companies are taking their profits now and not returning equity into the industry. As their products get older, they become less competitive as newer, more effective and safer products take their market share. Some companies have modest development programs but are not aggressively going after new therapies and production solutions. Some companies purchase molecules and expand their uses through supplemental applications. We see a few new dosage forms, but most advancements in dosage regimens are to meet convenience and labor costs requirements. The new molecules that we do see are largely being developed to compete for the same market niche. We see supplemental applications that change container sizes, labeling changes or enhancements that allow for marketing statements to give the appearance of superiority in highly competitive niche markets. Such business models will not lead the future of the industry.
Without a doubt there is a substantial demand to sustain cash flow and capitalization while such discovery work occurs. However, we cannot forget the long term health of the industry is vested in bringing novel pharmaceutical solutions to the marketplace.
The future of the pharmaceutical industry is vested in those sponsors who aggressively looking for these new market pies. These are the firms that say we need to open new markets deliver therapies or production solutions to agriculture or to companion animals meeting needs that have not been met. Large pharmaceutical firms need to reach out and support universities and small start up ventures and similarly small companies and universities need to be bringing forward new entities in collaboration with the corporate entities that have the wherewithal to bring novel products to the market. With the return on investment reaped from the investment in the user fee program, sponsors need to explore and discover new molecules that provide substantially improved safety and effectiveness; go after new molecules that will effectively treat diseases for which there is no approval; and find breakthroughs in pharmacologic solutions for here-to-fore untreatable diseases.
In order for us to meet the therapeutic and production needs of animals, we need to renew and refocus our development efforts on breakthrough science. Forward-looking sponsors have to be thinking about products that will deliver new therapies for the currently untreatable diseases, eliminate safety issues associated with current therapies and embrace heretofore untapped technologies. There are many economically important diseases that remain without effective therapy such as Johnes disease and cryptosporidia to name a few. NSAIDs have substantial target animal safety concerns, poultry coccidiostats are being associated with environmental concerns using current molecules. New therapies are needed and the economics are there to justify their development. We need to expand opportunities for food-producing animals to maximally utilize fed nutrients, enhance growth rates and minimize excreted nutrients while meeting consumers tastes.
Now is the time to return to hard scientific investigation both in academia and in the pharmaceutical industry targeted at finding cures for the diseases that up to now have been problematic such as Johnes, mastitis, cryptosporidiosis, or coccidiosis in poultry. We need to find production solutions to increase production capacities of our nation livestock and in aquaculture. On the companion animal side, we need to continue to forge ahead finding effective treatment for diseases such as has been started such as new treatments for EPM. We need to look to biotechnology for new products to tackle some of the more difficult therapeutic and production challenges such as gene therapy for cancer, gene insertion to produce animals resistant to specific disease, increased production efficiency and the production of healthier foods.
The future of pharmaceutical animal health products lies, in my opinion, in the reinvestment of these dollars in hard science to develop breakthrough products aimed at curing current economically important diseases. This will only occur if the pharmaceutical companies, academia, allied industries and associations redirect and refocus their efforts and support to endeavor in the scientific effort necessary to finding new therapeutic and production solutions.
by : S. Vaughn
In: 14th Biennial Symposium of the American Academy of Veterinary Pharmacology and Therapeutics AAVPT – 2005, Rockville, MD, USA, (Ed.). Publisher: American Academy of Veterinary Pharmacology and Therapeutics, Wilmington, DE, USA. Internet Publisher: International Veterinary Information Service, Ithaca NY (www.ivis.org), Last updated: 18-May-2005; P1815.0505