DeLauro Introduces Legislation to End Patchwork Oversight of Compounding Pharmacies

WASHINGTON, DC—Representative Rosa DeLauro (D-CT) introducedlegislation today to improve the failed regulatory framework currentlygoverning compounding pharmacies and clarify the Food and Drug Administration(FDA)'s ability to oversee such pharmacies. Contaminated products from asingle compounding pharmacy in Massachusetts were responsible for last year'sfungal meningitis outbreak that sickened over 700 people and caused over 60deaths.

"I wish this legislation were not necessary, but tragicevents have proven that it is. The devastation caused by contaminated productsfrom the New England Compounding Center, as well as products associated withother outbreaks, has made clear that strong Federal authority is necessary toensure patients know they are receiving safe compounded drugs. We shouldno longer rely on chance – like the sharp eyes of a nurse in New Haven whonoticed mold in what was supposed to be a sterile compounded product intendedfor intravenous administration – to ensure these products are safe. Ithas also become clear that federal and state regulators must better communicateto identify trouble facilities and leverage their resources to protectpatients."

Earlier this week, the Government Accountability Office issued a report underliningthe difficulties the FDA has had overseeing compounded drugs. The report notedthe "lack of consensus and differing FDA authority to oversee compounded drugsacross the country has resulted in gaps in oversight." Also this week, acompounding pharmacy announced the recall of more than 125 different types ofsterile 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 theirfacility with the FDA

· Ensure patients know they are receiving acompounded drug

· Establish a FDA database of information oncompounding pharmacies to inform oversight by the FDA and appropriate stateregulators

· Ask the FDA to set minimum production standards

· Direct the FDA to offer training opportunitiesfor state regulators

· Seek additional information on third partyaccreditation and the various models used by state regulators

· Improve communication between federal and stateregulators to facilitate more comprehensive inspections

DeLauro, a senior member of the committee responsible forfunding the FDA, first introduced this legislation last year. Originalcosponsors include Representatives John Conyers (D-MI), Mike Honda (D-CA), NitaLowey (D-NY) and Keith Ellison (D-MN).