The Need for Enhanced Oversight of Compounding Pharmacies

Compounding pharmacies play a critical role in the health care industry by providing custom-made medication combinations that are tailored to the health care needs of an individual patient. When done properly, compounding pharmacies are able to provide health care treatments for patients who cannot be treated with an FDA-approved medication.

Unfortunately, oversight for compounding pharmacies continues to be lacking and patients are suffering as a result. According to the Boston Globe, nearly 14,000 people in 20 states received tainted steroid shots manufactured by New England Compounding Company (NECC) last summer and early fall, which resulted in 750 cases of fungal meningitis and other infections – 64 of which were deadly.

Long after the steroid shots were recalled last October, the debate regarding enhanced oversight of compounding pharmacies continues. Last fall federal lawmakers held Congressional hearings regarding the need for enhanced oversight of drug compounding practices, during which Dr. Margaret A. Hamburg, the head of the U.S. Food and Drug Administration (FDA), testified that additional oversight authority over compounding pharmacies is necessary in order to prevent future contaminations and tainted drug problems.

Despite the urging of healthcare and medical experts, partisan debates in Congress have thwarted the passage of legislation that would tighten federal oversight of compounding pharmacies like NECC, and patients continue to be injured as a result. In fact, in August, the FDA announced a nationwide recall of products from a Texas compounding pharmacy due to bacterial bloodstream infections in 17 patients that were linked to one of the company’s products.

Patient advocates continue to urge Congress to pass appropriate legislation and express their frustration with the CDC for its inadequate leadership and investigation into compounding pharmacies.

“We don’t have a coordinated response across the health system to track these folks and to collect information periodically that describes what’s happening,” said Terri Lewis, a rehabilitation specialist at Southern Illinois University Carbondale.

Michigan – one of the state’s hardest hit by the NECC meningitis outbreak – is taking matters into its own hands. Michigan Attorney General Bill Schuette and state Rep. Joe Hune have proposed legislation that would require pharmacies to maintain records for all sterile compounded drug products and the name of the person who prepared the compound, submit to criminal background checks for pharmacy owners, and submit to regular inspections by state authorities at least once every two years. Additionally, pharmacies would be required to have a “pharmacist-in-charge,” who is responsible for ensuring full compliance with state laws and regulations.

Drug manufacturers, including compounding pharmacies, have an obligation to ensure that the drugs they make and deliver to patients are safe. When a drug manufacturer makes an unsafe pharmaceutical product, it can be held liable in a product liability lawsuit. The Chicago unsafe drug attorneys at Cogan & Power are dedicated to protecting consumers from unsafe medical products, including unsafe pharmaceuticals and dangerous medical devices.

If you have been injured or a loved one has died as a result of an unsafe pharmaceutical, please contact our office at (312) 477-2500 to schedule a free consultation to discuss a possible product liability lawsuit.