Department of the Interior, Environment, and Related Agencies Appropriations Act, 2018

Floor Speech

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Mr. Chairman, I rise today in support of my amendment to H.R. 3354, the fiscal year '18 appropriations bill.
My amendment would withhold funding from the Food and Drug Administration to implement a memorandum of understanding that redefines key terms in the healthcare industry: distribute and dispense.

Distributing and dispensing in the healthcare field are commonly understood to be unique and distinct activities. Distributing is understood to mean the sale or transfer of a drug without a prescription, like between a wholesaler and a manufacturer. Dispensing is commonly understood to mean a medicine going specifically toward a patient.

The FDA's attempt to redefine these key terms would be especially detrimental to compounding pharmacies. Compounding pharmacies are desperately needed to combine or mix medicines to meet the unique needs of particular patients.

In the Food, Drug, and Cosmetic Act, the FDA is given limited regulatory authority over how much a compounding pharmacy is allowed to ship across State lines, and more specifically, over how much a pharmacy can distribute across State lines. But since the FDA is now attempting to redefine the word ``dispense,'' the agency is attempting to gain more control over these pharmacies and is now limiting the amount of medicine that can go directly toward patients.

With the FDA redefining the word ``dispensing,'' the agency is now also limiting how much a State can dispense across State lines, creating an unnecessary patient access problem, especially for patients served by pharmacies near State lines.

This amendment is necessary to convey to the FDA that they do not have the authority to go against the intent of Congress and redefine key terms in agency documents that are directly against what Congress laid out in the statute and the commonly understood meaning of the industry itself.

The amendment will also enforce the directives in Congress' last two appropriations reports that have been ignored by the FDA.

Mr. Chairman, I want to repeat that. The amendment will also enforce the directives in Congress' last two appropriations reports that have been ignored by the FDA, as well as language in the new FY18 Appropriations subcommittee report.

As the only pharmacist in Congress, I have seen firsthand how important access to medications are for the people who need them. I have also seen how important compounded medications are for the individuals who rely on uniquely tailored medicines. It would be a tragedy for the FDA to limit these patients' access to medications because they redefined a term for which they would like to have more control.

I urge all of my colleagues to support this amendment that is crucial for patient access to important medications and stop the FDA from overreaching and going against the intent of Congress.

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