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National Defense Authorization Act for Fiscal Year 2014

Floor Speech

By:
Date:
Location: Washington, DC

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Mr. ISAKSON. Mr. President, I wish to thank Mr. Alexander for his work on this legislation. I am happy to see that all sides have been able to reach an agreement on clarifying the oversight of large compounding facilities, while also ensuring that patients continue to have access to customized medicines at their local pharmacy. I am grateful to the chairman and ranking member for clarifying that the intent of this legislation is to maintain current law with respect to patients' and physicians' access to drugs compounded for office use. I am also very encouraged that we are finally moving forward on creating a uniform national standard for the pharmaceutical supply chain, which will allow patients to have more confidence in the safety of the drugs they receive while also ensuring that national distributors and third-party logistics providers do not face the burden of dealing with a confusing and inconsistent patchwork of State-by-State rules.

I would like to take a moment to discuss an issue that is not directly addressed in the bill before us. I have heard from my constituents that there are serious problems, similar to the ones we are seeking to address today, with the inappropriate compounding of animal drugs. As with human drugs, mass production of compounded animal drugs with inadequate safety standards has resulted in suffering and death.

While the compounding of animal drugs according to a prescription from a veterinarian for an individual patient is legal, necessary, and appropriate, it is important to draw a line between compounding and manufacturing. I am especially troubled by reports that some entities characterizing themselves as ``compounding pharmacies'' are producing large quantities of animal drugs that are essentially copies of FDA-approved products. They are then mass-marketed as cheap alternatives to approved products, without being subject to any of the safety requirements and quality controls that manufacturers must comply with.

As with human drugs, the FDA has had mixed success in taking enforcement action against questionable or abusive animal drug compounding practices. While I understand that animal drug compounding raises complicated issues that the bill before us does not address, I want to make it clear that the absence of animal drug provisions in this legislation does not constitute an endorsement of the status quo. I hope that in the months ahead, Congress can begin to investigate the issues surrounding animal drug compounding in more depth, with an eye toward spurring the FDA to make this a higher enforcement priority.

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