WASHINGTON, DC—Representative Rosa DeLauro (D-CT) introduced legislation today to improve the failed regulatory framework currently governing compounding pharmacies and clarify the Food and Drug Administration (FDA)’s ability to oversee such pharmacies. Contaminated products from a single compounding pharmacy in Massachusetts were responsible for last year’s fungal meningitis outbreak that sickened over 700 people and caused over 60 deaths.
“I wish this legislation were not necessary, but tragic events have proven that it is. The devastation caused by contaminated products from the New England Compounding Center, as well as products associated with other outbreaks, has made clear that strong Federal authority is necessary to ensure patients know they are receiving safe compounded drugs. We should no longer rely on chance – like the sharp eyes of a nurse in New Haven who noticed mold in what was supposed to be a sterile compounded product intended for intravenous administration – to ensure these products are safe. It has also become clear that federal and state regulators must better communicate to identify trouble facilities and leverage their resources to protect patients.”
Earlier this week, the Government Accountability Office issued a report underlining the difficulties the FDA has had overseeing compounded drugs. The report noted the “lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight.” Also this week, a compounding pharmacy announced the recall of more than 125 different types of sterile compounded products that had been distributed nationally.
The Supporting Access to Formulated and Effective (S.A.F.E.) Compounded Drugs Act would:
· Require compounding pharmacies to register their facility with the FDA
· Ensure patients know they are receiving a compounded drug
· Establish a FDA database of information on compounding pharmacies to inform oversight by the FDA and appropriate state regulators
· Ask the FDA to set minimum production standards
· Direct the FDA to offer training opportunities for state regulators
· Seek additional information on third party accreditation and the various models used by state regulators
· Improve communication between federal and state regulators to facilitate more comprehensive inspections
DeLauro, a senior member of the committee responsible for funding the FDA, first introduced this legislation last year. Original cosponsors include Representatives John Conyers (D-MI), Mike Honda (D-CA), Nita Lowey (D-NY) and Keith Ellison (D-MN).
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