November 29, 2012 — Public Citizen, a consumer advocacy group, has sent a letter to the director of the U.S. Food and Drug Administration (FDA) requesting that the agency re-inspect 16 compounding pharmacies that have received warning letters since 2003 for safety violations. The group says that the warnings “reveal a thriving [drug making] industry … being carried out under the guise of compounding.”
Compounding pharmacies have faced increasing scrutiny after a massive outbreak of fungal meningitis was linked to New England Compounding Pharmacy, which was allegedly mass-producing medicines without a license. Contaminated medicines from the pharmacy have been linked to more than 500 illnesses and 36 deaths in 19 states.
After the outbreak, the FDA requested increased authority to regulate the industry. Although compounding pharmacies are only supposed to mix small batches of custom medications with specific prescriptions, some have started to sell large quantities of drugs like small pharmaceutical companies.
When Public Citizen reviewed the FDA’s public database of adverse events, they found that the FDA sent 18 warning letters to 16 compounding pharmacies in 15 states from 2003 until 2012. Most of the warning letters were for problems with manufacturing or safety. However, five warning letters involved complaints of patient illnesses and deaths linked to compounded medicines.
Public Citizen found that the FDA received 70 adverse event reports that were possibly linked to an injectable steroid. The recent outbreak of fungal meningitis was also linked to the steroids, which are often injected directly into a patient’s spine to treat back pain.
Other reports involved injections contaminated with bacteria. One report involved a 25 year-old female who died after applying a toxic amount of an anesthetic skin cream.
In addition to the adverse event reports, Public Citizen also expressed concern that there was no evidence that the FDA followed up with any of the compounding pharmacies that received warning letters. The group requested re-inspection of the pharmacies, and initiation of a “systematic program to determine whether other compounding pharmacies are engaged in illegal practices.”
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