A state requirement could protect Pennsylvanians
The fungal meningitis outbreak in 2012 that killed 61 people and sickened 749 more in 20 states exposed a serious flaw in the nation's drug safety regimen.
Investigators traced the contamination that caused the illnesses to a compounding pharmacy in Massachusetts. Compounding pharmacies do not manufacture original drugs but combine drugs in specific doses for specific patients, as ordered by hospitals or doctors.
Even though compounders like the New England Compounding Co. that was complicit in the outbreak ship across state lines, they are regulated by agencies in their home states rather than by the U.S. Food and Drug Administration.
After the outbreak a bipartisan group of senators introduced the Pharmaceutical Quality, Security and Accountability Act to give the FDA greater regulatory sway over compounders. It provided a new class of compounding pharmacy that would be treated as a drug manufacturer, which are regulated by the FDA.
It would exempt hospital or health-system pharmacies that compound medications for their own patients.
Unfortunately, the bill has been watered down in discussions with the House, so that it would be up to individual compounding pharmacy companies to register with and covered by the FDA.
The problem that led to the outbreak was a lack of consistent regulations and enforcement at the state level. A new federal law should establish consistency by mandate rather than leaving it to individual companies.
To ensure safety, Pennsylvania should require health care providers here to order compounded medicines only from companies that have submitted to regulation by the FDA. Doing so will protect Pennsylvanians, diminish providers' liability and create momentum for consistent national rules.