An October 29 Reuters article announced the fungal meningitis outbreak has spread to 19 of 23 states which received contaminated steroid medications from the New England Compounding Center (NECC) according to the U.S. Centers for Disease Control and Prevention (CDC). Rhode Island has now reported its first case. The total number of cases reported is 347, having increased by 10 reports since Saturday. Twenty-five people have died, and seven cases have been reported of infections following injections in various joints (knee, hip, shoulder, elbow, etc.), so that the total number of reported cases of infections is 354.
According to an article in MedPageToday, October 29, the fungal meningitis outbreak has heightened concern by state pharmacy boards throughout the country that compounding pharmacies must comply with “nationally accepted pharmacy standards and… regulations,” according to Dr. Madeleine Biondolillo, Director of the Massachusetts Bureau of Health Care Safety and Quality. Massachusetts health officials identified some “significant issues” at another Massachusetts compounding pharmacy, Infusion Resource (Waltham, MA), which prepares injectable medications; and Florida suspended the license of Rejuvi Pharmaceuticals (Boca Raton, FL) after an inspection identified several violations of that state’s compounding pharmacy rules. (MedPageToday, 10/29/12)
According to the Boston Globe, “Former regulators and legal scholars say the Food and Drug Administration has lacked enough authority and resources to effectively monitor compounding pharmacies.” These companies often custom-produce drugs sometimes not available commercially—including “treatments in short supply” or drugs removed from the market due to lack of demand.
I.Glenn Cohen, Harvard law assistant professor, who co-directs its Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, says that for the FDA “to perfectly enforce the statutes FDA would need a much larger budget.” (Boston Globe, 10/29/12) Congressman Edward Markey of Massachusetts has released a report noting that the compounding industry has typically resisted the federal government’s role in its oversight. Markey says, “The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight.” (Boston Globe) The Honorable Ed Markey also introduced the Safe Drug Compound Act of 2007, which never came to a vote due to opposition from the compounding pharmacy lobbyists and trade groups that held the position the law would “prevent the speedy delivery of medications not available at traditional pharmacies.” (Boston Globe)