Inconsistent state oversight of specialty pharmacies that mix their own medicines, like the one linked to the U.S. meningitis outbreak, shows the need for greater federal oversight, Representative Edward Markey said.
State pharmacy boards focus on licensing activities and pay little attention to safety enforcement, said Markey, a Democrat from Massachusetts, where the pharmacy linked to 25 meningitis deaths is located. Markey, in a report released yesterday, said the federal Food and Drug Administration does a better job making information publicly available that may help consumers avoid dangerous medicines.
Markey plans to introduce legislation that would require compounding pharmacies to register with the FDA and comply with minimum safety standards. The move adds to other legislative proposals and two congressional investigations related to New England Compounding Pharmacy Inc., known as NECC, which this month recalled more than 17,000 vials of a steroid for back pain after tainted doses were linked to a fungal meningitis outbreak that has infected 354 people, including 25 deaths.
“The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight,” Markey said in a statement. “This tragedy demands the strongest response from Congress and federal and state authorities to ensure safeguards are in place to protect patients.”
Compounding pharmacies are supposed to mix drugs on a small scale in response to patient prescriptions for treatments that aren’t available elsewhere, for example for a unique dose of a medicine.
Massachusetts regulators have moved to permanently revoke the license of NECC, citing evidence of unsanitary manufacturing conditions and business practices that may have exceeded the scale and scope that is typically allowed.
Massachusetts also has begun a statewide inspection of compounding facilities. It secured the voluntary surrender of the license for Infusion Resource because of conditions at the facility in Waltham, Madeleine Biondolillo, director of the Bureau for Health Care Safety and Quality, said yesterday at a news conference. Investigators questioned the sterility of injectable drugs at Infusion and said the company had a space set up to give patients intravenous medications on site, even though it doesn’t have a clinic license.
Excluding the latest incidents at NECC, FDA records documented 23 deaths and 86 serious injuries since 2001 associated with compounding pharmacies, which are currently exempt from most federal oversight, according to Markey’s report. The deaths ranged from more meningitis illnesses to overdoses of numbing cream for laser hair removal that was made much more potent than was allowed.
While the FDA posts online searchable warning letters about safety violations, only six states post enforcement actions on the Internet that advise consumers a pharmacy may have made contaminated products at one time, according to Markey’s report.
Meningitis is an inflammation of the lining of the brain and spinal cord. The FDA has said about 14,000 people received shots of the NECC steroid, which is injected into the spinal cavity to relieve neck and back pain.
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