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Public Statements

Drug Quality and Security Act

Floor Speech

Location: Washington, DC


Mr. COBURN. Mr. President, it has now been about 1 year since the fungal meningitis outbreak last fall associated with the tainted sterile compounded drugs from the New England Compounding Center. This week on the floor of the Senate, we have a bill that is, in many senses, Congress's response to the lack of policy clarity that many have suggested failed to prevent that tragedy.

As I have watched the Senators and their staff who have been working on this bill over the past several months, I applaud the bipartisan manner they have used in creating legislation that could help prevent similar tragedies in the future.

I am planning on voting for this legislation because I do think Congress needs to legislate. The courts have not been clear. However, I want to note that, despite the strong bipartisan collaboration, this legislation leaves some regulatory oversight concerns outstanding that I want to comment on and make clear today.

There has been a lot of concern that by reaffirming section 503(a) of the Food, Drug and Cosmetic Act, office use of compounded drugs is not recognized as permissible compounding activity. Therefore, I want to make clear that this legislation does not change current State law or authority over the dispensing or distribution of medications by pharmacists, compounded or manufactured, for a prescriber's administration to or treatment of a patient within their practice.

Currently, the compounding and dispensing of prescription drugs for in-office administration by a prescriber to their patient is governed by State boards of pharmacy, and States have determined what is best for their State regarding office use. In fact, more than 40 States have passed laws over the last 15 years related to current practices of using compounded drugs in the office context.

The issue of office use, indeed all of pharmacy practice regulation, is best left to the States. So the omission of office use from 503(a) should not signal to the FDA that it has the authority to encroach upon State authority to regulate office use.

In addition, there have been concerns whether the provisions within the legislation that grant authority to the FDA to set up systems of procedure for the direct communication between State boards of pharmacy and the FDA will give FDA more authority over compounded prescriptions shipped across State lines. I want to also take this opportunity to make clear that these provisions within the legislation require ``appropriate investigation'' on complaints and other issues that arise by the FDA and in no way provide some new expansive authority to the FDA to restrict interstate commerce or regulate intrastate commerce.

Finally, the legislation does not change the ability of ophthalmologists to administer drugs in their office to individual patients for the purposes of reducing macular degeneration. Under this legislation, physicians retain the ability to use compounding drugs in their office for their patients. This is a practice-of-medicine issue, so the art and science of medicine should not be impeded by the FDA.

I will continue to monitor the implementation of section 503(A) in consultation with physicians, medical professionals, and pharmacy professionals. I also strongly encourage the FDA to ensure that these provisions are not used to restrict office use and restrict interstate sales of compounded pharmaceuticals within all applicable laws and regulations.

I suggest the absence of a quorum.


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