A top Food and Drug Administration official said Tuesday the reauthorization of the agency's animal drug user fee agreements would help speed up its process of approving generic animal drugs, decreasing the cost of caring for food-producing and companion animals.
"The current reauthorization significantly reduces timeframes for getting these products to the market, so that was something the generic drug industry and FDA sat down negotiated, reduced this timeframe so we can get more generic animal drugs to the market," Steven Solomon, director of the FDA's Center For Veterinary Medicine, told the Senate Health, Education, Labor and Pensions Committee as the panel considers renewing the program.
"The generic animal drug industry is a relatively new industry. It is really growing. Over the past authorization [from 2013 to 2018], there was an increase in work that was really positive," Solomon continued. "We had over 50 percent increase in workload. Very positive sign that more generics are coming to the market."
The FDA program, first introduced in 2004, allows for the collection of fees for certain generic and pioneer animal drug applications from their developers, according to the agency's website.
The revenue raised through the initiative, which aimed to generate $114 million in user fees between 2013 and 2018, provides additional resources for the FDA to ensure the drugs are safe for animal and human health in exchange for quicker certification, which on average takes between six and eight years at a cost ranging from $22 million to $30 million for the companies, per HELP Committee Chairman Sen. Lamar Alexander, R-Tenn.
Last year, 240 generic animal drug applications were received by the FDA, Alexander said during his opening statement.
Solomon was also grilled on what steps the FDA is taking to encourage the judicious use of antibiotics in animal care. He said the agency is working to improve usage data collection to measure the success of education strategies implemented by stakeholders, including veterinary associations.
In addition, he promised to collaborate with Sen. Rand Paul, R-Ky., on enhancing the efficacy of how the FDA approves naturally-occurring food additives, such as algae and hemp products.
Alexander said he hopes the committee would mark-up the animal drug user fee agreements by the end of February before the current reauthorization expires on Sept. 30.