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The Introduction of the S.A.F.E. Compounded Drug Act

Floor Speech

By:
Date:
Location: Washington, DC

Ms. DeLAURO. Mr. Speaker, I rise today to introduce the Supporting Access to Formulated and Effective Compounded Drugs Act, or the S.A.F.E. Compounded Drug Act. My colleagues Congresswoman Nita Lowey of New York, Congressman Conyers of Michigan, and Congressman Honda of California are cosponsors of this legislation and I thank them for their work on this issue.

This bill seeks to ensure that patients and health care providers across the country have access to safe compounded drug products.

As you know, a devastating fungal meningitis outbreak last year was associated with contaminated products from a compounding facility in Massachusetts. Nearly 750 Americans became ill from these products and 61 perished. Unfortunately, this tragic outbreak and the others we have seen since are not anomalies. They are the result of a broken system. My thoughts and prayers are with the individuals and families whose lives have been affected by these contaminated products.

Earlier this week the Government Accountability Office released a report on drug compounding. That report noted that ``lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight.'' Gaps that clearly risk the public health.

Just this week a compounding pharmacy announced the recall of more than 125 different types of sterile compounded products distributed nationally. Five days after the company began notifying its customers of the recall, a recall notice was published by the FDA. These products are being recalled because of a ``question of sterility assurance.'' Thankfully no illnesses have been identified, but it is imperative that we act now and not wait for another heart wrenching outbreak and ask ourselves if we could have prevented it in the first place.

The bill I am introducing today should be part of our work to fix the system. It would do five things: clarify Federal authority of compounding pharmacies, improve patient and provider notification with accurate labeling, improve communication between Federal and state regulators, seek additional information to improve our understanding of the complexities related to compounded products, and strengthen penalties.

I urge my colleagues to support this bill.


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