Drug Quality and Security Act

Floor Speech

BREAK IN TRANSCRIPT

Ms. DeLAURO. Mr. Speaker, I rise in opposition to the act before us. I support the track-and-trace provisions to prevent fake medication from entering the drug supply, and I commend the ranking member for his efforts.

But the voluntary approach to regulating large-scale compounding pharmacies in this bill is not strong enough to ensure the public's safety in this arena.

This is a life-and-death issue. Last year, one single compounding pharmacy in Massachusetts caused a fungal meningitis outbreak that sickened over 700 people and caused over 60 deaths, which is why I introduced legislation to draw a clear line between whether a business is a traditional compounding pharmacy or a drug manufacturer, like the one in New England, and to ensure the proper mandatory FDA regulation of compounding drug manufacturers shipping mass amounts of drugs across State lines.

Under this bill, large-scale, high-risk compounding manufacturers would voluntarily register with the Food and Drug Administration without meaningful enough penalties for failing to comply. That New England Compounding Center, responsible for over 60 deaths, would not have to register. This voluntary approach will continue to expose patients to potentially unsafe mass-produced compounded drugs that are not approved or evaluated by the FDA for safety, efficacy, and adequate directions for use. It is an approach that can do real harm, and it is time for the FDA to be the regulatory agency it was intended to be.

At the very least, given that lives are at stake, the House should consider this issue as a stand-alone bill, through regular order, with the opportunity for amendments.

It should not be on a suspension calendar; and as it is on the suspension calendar, I must oppose this bill.

BREAK IN TRANSCRIPT

Source