Pew Comments on FDA Proposal to Expand Conditional Approvals for New Animal Drugs

Agency should consider impact of guidance on antibiotic resistance and narrow scope

Pew Comments on FDA Proposal to Expand Conditional Approvals for New Animal Drugs

The Pew Charitable Trusts urged the U.S. Food and Drug Administration to narrow the scope of Draft Guidance for Industry #261 in comments submitted Jan. 23. As currently drafted, the guidance would allow more types of new animal drugs to qualify for conditional approvals. With a conditional approval, a developer can bring a drug to market while working to prove its effectiveness.

Although animal antibiotics would not qualify for conditional approval under the proposed guidance, alternatives to such antibiotics would and this could result in unintended consequences. If new antibiotic alternatives are approved and used, but ultimately found to be ineffective, that could result in a range of potential harms to both animal and human health. Those could include delayed onset of effective therapy, increased need for antibiotics, and accelerated emergence of resistance.   

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