FDA Regulatory Regimes in Facilitating the Approval of Animal Drugs
In the wake of modern pharmaceutical developments, drugs used to promote animal growth, including some antibiotics, gained political support several decades ago. From an economic and industrial point of view, drugs can save production costs and enhance production by shortening feed cycles.
Fulfilling the policy to develop the food-producing animal industry, two federal laws tended to facilitate the marketing of these drugs.In 1968, Congress passed the Animal Drug Amendment to the FDCA,[29] which provides a simplified procedure for new animal drug approvals. Seeking to streamline the approval process and soften the burden on drug companies, the 1996 Animal Drug Availability Act[30] emphasizes collaboration between the FDA and the industry in building a common understanding of data submissions, and, in particular, field tests for animal drugs are no longer required.[31] In short, the FDA policy on animal drugs has maintained a pro-industry orientation.
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