In this space last week, Bob Jones published a thought-provoking Viewpoint on the topic of FDA Animal Drug User Fees. He asked if readers felt that the User Fee amounts are reasonable. Not surprisingly, 57% said the fees are too high.
I recently read “Flying Blind: The 737 MAX Tragedy and the Fall of Boeing” by Peter Robison. Robison outlined the issues regarding the 737 MAX and the accidents that resulted. A recurring theme is the policy of the Federal Aviation Administration (FAA) to “outsource” oversight of airplane development to the manufacturers themselves. Boeing made decisions about the development of this plane and the training for its pilots that would have been visible to a competent and independent regulator; unfortunately, the FAA lacked the understanding to challenge these decisions and 346 people died in 2 crashes, resulting in the grounding of the airplane and one of the costliest corporate scandals ever.
So…what does this have to do with Animal Health? The industry agreed to support CVM’s efforts through the User Fee system maintaining expertise and providing for certainty in the review process. Yes, it can take a lot of money to register a new compound or a new generic drug; however, the regulatory system continues to help our industry maintain a position in our society that we can be proud of. And that has a value that is certainly real.
Jim Kroman
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