Critical quality control issues at two New England pharmaceutical processing centers highlights the risk dangerous pharmaceuticals have on patient health.
Queens medical malpractice attorneys understand this is the latest in a long series of examples of dangerous medical products leading to serious or fatal injuries in clinics and hospital settings nationwide.
While Congress is holding hearings and ostentatiously blasting the Food & Drug Administration for not doing a better job of protecting the public, the FDA has been warning about the dangers of pharmaceutical compounding centers for more than a decade. In fact, Congress killed a compounding safety act sponsored by the late Senator Ted Kennedy amid heavy lobbying from the pharmaceutical industry.
Thus, loopholes in oversight have largely left regulation to state boards of pharmacy.
As Reuters News reported, Congress was given a report in 2001 that found 10 of 29 drugs tested did not pass quality control. Some had less than 70 percent of stated potency.
“They had ample warning of problems in this industry,” said Sarah Sellers, a pharmacist who worked in compounding before joining the FDA in 2005 to work on compliance issues surrounding compounding.
And people are now dying as a result. Problems at the New England Compounding Center are blamed for at least 33 deaths and 500 injuries as a result of fungal meningitis found in contaminated back steroids.
Now a sister agency, Ameridose, a major supplier of injectable medications to hospitals and health clinics nationwide, will be shut down until at least the first of the year, according to the Boston Globe. The companies share ownership and are both located in the Boston area.
The closure agreement also includes Alaunus Pharmaceuticals, a wholesale distributor with the same owners. Health officials are working with clinics nationwide to address the resultant drug shortages. The FDA announced last week that numerous contamination and quality control issues were found at Ameridose.
However, it’s important to note that the FDA has apparently known for years about the poor safety records of both companies. Only after scores began dying from contaminated injections has enforcement action been taken.
The USAToday reported drugs used to treat children and pregnant women were being mixed and packaged in non-sterile conditions, including rooms with leaky ceilings and at least one bird flying around.
According to the FDA, the firm: “fails to test finished product for potency, failed to investigate complaints for ineffective products, failed to investigate violations of their own environmental sampling plan and fails to adequately maintain equipment and facilities used to manufacture sterile drug products.”
These cases can be medically and legally complex. The takeaway here is that an independent review should always be conducted when a loved one suffers serious or fatal medical complications. History proves you cannot count on the medical industry to put patient safety ahead of profits. And, unfortunately, state and federal watchdogs too often fail to take action until it’s too late.
The Law Offices of Nicholas Rose, PLLC offers free consultations to injury victims and families. Call 1-877-313-7673.
F.D.A. Chief Seeks Expanded Authority to Improve Safety of Drug Compounders, By Sabrina Tavernise, New York Times, Nov. 14, 2012.