The American Sheep Industry Association filed comments last month concerning the Food and Drug Administration’s request for input on Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs.
ASI is certainly in favor of looking at new approaches to the drug approval process. Pharmaceutical companies have continued to abandon the development of new drugs for sheep as the American sheep population has declined dramatically in the past 60 years. While important drugs for sheep continue to be developed in countries such as Australia and New Zealand, companies don’t see value in navigating a lengthy approval process for these drugs to be sold in the United States.
This is why ASI is in favor of allowing FDA to consider data from foreign countries as part of the approval process.
“Increasingly stringent regulatory requirements for animal drug development discourage U.S. animal health companies from pursuing the manufacturing of products readily available in major sheep producing countries,” wrote Dr. Jim Logan and Dr. Cindy Wolf on behalf of ASI in comments filed with the FDA. “Because of the size of their sheep industries, countries such as New Zealand and Australia often have several choices of products available to producers to address common sheep health issues. Whereas, the U.S. may have only one or even none.
“This puts our animals at risk of disease, lowers the quality of life for the animal and threatens the viability of sheep operations. In addition, it is a trade disadvantage as it allows our competitors to raise their animals less expensively. Given these circumstances, we believe a process by which data from foreign countries could be incorporated into the approval process for minor use species is warranted. We have given consideration to what such a process might look like. It will not be easy to create but we do believe it can be accomplished.
“For example, in Canada, they recently completed a joint regulatory review of an animal health product out of New Zealand in order to obtain approval for the Canadian market. The sheep industry in Canada has approached ASI about the possibility of approaching our respective governments to request development of a joint regulatory framework for the approval of a deworming product that is available in Australia but is not available in either the U.S. or Canada. We believe such a regulatory agreement could be a valuable tool to address the growing need for minor species pharmaceuticals while reducing the cost and work burden of what are very similar requirements between our countries.”
ASI is also in favor of using real world evidence in the approval process.