Drug Quality and Security Act

Floor Speech

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Ms. DeGETTE. Mr. Speaker, almost exactly 1 year ago, as you've heard, there was a tragic meningitis outbreak in Massachusetts; 64 people lost their lives, and 750 people were sickened.

In the investigation of NECC, the compounding pharmacy, there was found black specks floating in the vials. There was found fungal material. The factory, itself, had greenish yellow residue on supposedly sterile equipment and surfaces that tested positive for mold and bacteria.

In a series of hearings in our committee, we learned that the Food and Drug Administration Modernization Act of 1997 left a loophole large enough to allow large drug compounders to escape oversight by the FDA. The wording of the act also led to litigation and confusing court decisions about the FDA's authority over those manufacturers.

This bill takes the first, albeit important, step to address these issues. It incorporates important pieces of bipartisan legislation, as you've heard, that I have introduced with the gentleman from Virginia (Mr. Griffith) and the gentleman from Texas (Mr. Gene Green). It deletes the provisions from existing law that were deemed unconstitutional by the courts. It also enhances cooperation between State boards of pharmacy and the FDA; and it gives doctors and hospitals the ability to purchase compounded drugs for their patients made in a facility that is subject to stringent FDA quality standards and oversight. Importantly, all other compounding pharmacies would continue to be subject to current law. Finally, the Drug Quality and Security Act will require within a decade the implementation of a nationwide system for the tracking and tracing of drugs as they move through the supply chain from manufacturer to pharmacy.

I believe this will go a long way toward preventing dangerous counterfeit and substandard medicines from entering our drug supply. We still have work to do. We all agree with that. And I am committed to strengthening the law.

The SPEAKER pro tempore. The time of the gentlewoman has expired.

Mr. WAXMAN. I yield the gentlelady an additional 30 seconds.

Ms. DeGETTE. I am committed to strengthening this law so that we never have any other tragedy such as what Mr. Griffith discussed, where we have a Doug Wingate who right now is missing his 25th anniversary cruise because he was killed by these tainted drugs.

I'm proud to have worked with my colleagues from both sides of the aisle. I associate myself with the chairman emeritus' remarks that we should be able to do this on the continuing resolution and on the debt limit.

I also want to thank all of our staff; and, in particular, my chief of staff, Lisa Cohen, who spent the entire August recess working on this. And I thank the chairman.

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