Contaminated steroid injections blamed for at least 32 deaths in 19 states have led federal investigators to sterility problems at a second New England drugmaking facility. Ameridose is one of the leading suppliers of pre-filled syringes and is now under fire in a widening probe into dangerous drugs that have put thousands of patients at risk.
Alabama pharmaceutical attorneys understand the widening probe into activities at Ameridose means the risks may be far from over. Ameridose agreed to shut down for inspection in October after its sister company, the New England Compounding Center, was blamed for distributing steroid injections containing fungal meningitis to health clinics nationwide.
USA Today reported this week that the head of the Food and Drug Administration will ask lawmakers to grant the agency more authority to oversee such compounding facilities. Congress is racing through hearings and calling for legislation so there is now little doubt reforms will be enacted. However, as Reuter News reports, Congress has known about the risks posed to consumers by such facilities for a number of years. In 2007, it killed the Safe Drug Compounding Act sponsored by the late Senator Ted Kennedy amid heavy lobbying from the pharmaceutical industry.
In the report given to Congress, 10 of 29 drugs provided by compounding facilities failed one or more quality-control test. Including nine that failed potency tests — some testing less than 70 percent of dosage. That compares to just four failures of more than 3,000 tested samples provided by drug manufacturers. Because of Congressional inaction, licensing and inspection of such facilities largely relies upon state agencies.
Problems at the New England Compounding Facility were reported as far back as 1998 — just one year after it opened and was granted a license to operate by the Massachusetts Board of Pharmacy. The head of the state’s pharmacy board has since been fired. The Centers for Disease Control and Prevention reports more than 400 have now been sickened. The company’s entire product line is under recall. The Alabama Department of Public Health reports 44 health care facilities received products from the NECC that are now under recall, including injectable drugs, epidurals, and medications used in eye and heart surgeries.
Now the problems at Ameridose have the potential to exacerbate the crisis. The Montgomery Advertiser reports federal inspectors have found a host of problems at the facility, including ineffective drugs meant to be administered to children and women, leaky ceilings, insects, non-sterile conditions and even a bird flying around the facility. While no deaths have yet been reported, problems at the facility date to 2008, according to a 20-page report released by the FDA.
In at least 58 separate incidences, Ameridose staff is accused of not investigating contamination of bacetia or fungi found in sterile liquid used in pain relief and anesthetic injections. Ameridose provides medications in prefilled syringes to hospitals nationwide.
These are tragically preventable cases that illustrate the dangers medical patients face every day. These companies are operating as for-profit enterprises. Too often, clinics, hospitals and other medical establishments are cutting corners and ordering medication from such compounding or mixing facilities as a way to cut costs. And, as we see again in this case, consumers cannot count on the FDA to be anything more than reactionary.
If you believe you have been injured by a dangerous pharmaceutical or defective medical product, speak to an experienced Alabama law firm today.
FDA finds contamination concerns at Ameridose Alabama 13 News, Nov. 12, 2012.
Birmingham Trucking Accident Attorneys Look at Top Causes of Tractor-Trailer Crashes, Published by Cross & Smith, Nov. 8, 2012.