On September 28, 2015, the U.S. Government Accountability Office (GAO) issued a report to the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce on animal drug compounding. The GAO reviewed and analyzed regulation of animal drug compounding and concluded that FDA oversight could be strengthened, and recommended that executive action be taken to: (1) modify the adverse event reporting form to detect more adverse events arising from compounding, (2) develop policy for enforcing of compounding regulations for animals, and (3) more consistently document the bases for FDA decisions in the area.
Nonetheless, no regulatory or statutory changes were recommended and no projections were provided on the effect that the recommendations, when implemented, would have on animal health or animal drug compounding practice in the U.S. FDA is in the process of updating its guidance in this area and a notice and comment rulemaking is under way. The comment period on the new guidance has been extended until November 16, 2015. This guidance likely will interest those in the animal health industry. Husch Blackwell’s Animal Health Team is available to facilitate submission of comments by those potentially affected.
What This Mean to The Animal Health Industry
Compounders of animal drugs may face an increase in enforcement activity from FDA, but without changes in laws, regulations or funding, FDA’s ability to bring about major change will be limited. Those stricter enforcement against animal drug compounding may not be satisfied with the changes brought about by the GAO report.