Pharmacy Violations Resulted in Deaths and Illness across 34 States in Years Prior to Meningitis Outbreak
Compounding pharmacies killed nearly two dozen people and sickened many others before a Massachusetts facility drew national attention to the industry following the recent deadly meningitis outbreak.
A review of Food and Drug Administration (FDA) records and news reports by Representative Edward Markey (D-MA) revealed compounding pharmacies were responsible for 23 deaths and 86 cases of serious illness, all of which occurred prior to the latest controversy at the New England Compounding Center.
The Framingham-based company has been accused of selling tainted methylprednisolone acetate to doctors and clinics that killed 25 and sickened 344 in 18 states.
Markey released the report to make the case that FDA oversight of compounding pharmacies must be strengthened. Lawmakers in Congress are now discussing whether to adopt legislation that would give the agency more power over the industry.
Some consumer advocates, however, insist the FDA has the necessary authority to better regulate compounding pharmacies. The advocacy group Public Citizen recently urged the Department of Health and Human Services to investigate why the FDA did not do more to prevent the meningitis outbreak.
To Learn More:
Markey pushes for new pharmacy regulations (by Andy Metzger, Boston Globe)
U.S. regulator needs new authority over compounding pharmacies: report (by David Morgan, Chicago Tribune)
Compounding Pharmacies, Compounding Risk (Rep. Edward J. Markey) (pdf)
FDA reports conditions observed at New England Compounding Center facility (FDA Press Release)
Failure to Regulate Leads to Deadly Outbreak of Meningitis (by Noel Brinkerhoff, AllGov)
FDA Allows Manufacturers to Self-Regulate Safety of New Ingredients (by Noel Brinkerhoff, AllGov)
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