National Defense Authorization Act for Fiscal Year 2014

Floor Speech

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Mr. BOOZMAN. Mr. President, more than a year ago we witnessed the fatal New England Compounding Center meningitis outbreak. The Food and Drug Administration failed to pursue enforcement action against NECC, despite clear warning signs. Moreover, the Massachusetts Board of Pharmacy did not do its job. It failed to provide basic oversight. This inaction allowed a criminal compounder to operate with impunity--ending the lives of many Americans.

In contrast, the Arkansas Board of Pharmacy is competent and thorough. It does a great job. Arkansas regularly inspects all pharmacies. We are a small State, but we run a tight ship.

However, Arkansas has no way of knowing whether other State pharmacy boards are doing their job.

We need to take steps to protect patients from precarious, poorly inspected, out-of-State drugs. However, I want to make clear of something before we move on this legislation.

The practice of pharmacy, including pharmacy compounding, is a State issue. Nothing in this law changes that. Compounded drugs for office-use is a State issue. Nothing in this law changes that. Commonplace drug repackaging for drugs--like Avastin--is a State issue. I relied on compounders regularly when I practiced in a surgery center. Office-use compounding and repackaging is acceptable under Arkansas law. Nothing in this law changes that.

The omission of office-use from section 503(a) of the Food, Drug, and Cosmetic Act should not signal to the FDA that it has the authority to encroach upon State authority to regulate office-use. This is not the intent of the law, and I will closely monitor FDA implementation as this process moves forward.

If the State of Minnesota wants to prohibit drug repackaging and compounding--that is its decision. But again, this law is by no means a green light for the FDA to usurp the rights of States. I want to make that crystal clear.

Lastly, contrary to much of what has been said, compounders have really stepped up to assist providers in need. Today, America faces a serious drug shortage problem. Sterile injectable generic drugs constitute 80 percent of the drugs in short supply.

Not surprisingly, government pricing caps have caused these shortages. Thankfully, compound pharmacists in Arkansas and across the country have been meeting critical market needs that manufacturers have been unable to satisfy. Compounders have helped address supply chain gaps and sudden spikes in demand--particularly in rural and neglected areas. They have plugged holes in the system, and they have tended to overlooked markets.

Without compounders, doctors would not perform surgeries. Without compounders, oncologists would be forced to administer alternative chemotherapy drugs. Without compounders, patients would suffer from limited access. These are real issues and real problems, and we must take these realities into consideration. I look forward to working with all stakeholders to ensure commonsense compounding, repackaging, and office-use administration of compounded drugs.

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