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Congressional Hearings on Compounding Problems and Meningitis Outbreak

Written by Ankin Law Office

The nation has been rocked by the staggering death toll from the recent meningitis outbreak. Currently more than 461 have people have become ill and at least 32 people have died as a result of contaminated steroid shots.

Last week federal lawmakers held Congressional hearings as part of an investigation of New England Compounding Company (NECC), the drug company linked to the meningitis outbreak, as well as drug compounding practices in general. According to the Washington Post, the head of the U.S. Food and Drug Administration (FDA) testified that additional oversight authority over compounding pharmacies is required in order to prevent future contaminations and tainted drug problems.

Compounding pharmacies are those drug manufacturers that mix customized medications based on prescriptions. Under the current system, state and federal agencies share oversight. Courts often disagree about state and federal authority over compounding companies, which has “hampered [the FDA’s] ability to act to protect patients and prevent, rather than just react to, safety concerns,” according to FDA Commissioner Margaret A. Hamburg.

Contrary to the FDA’s position to request additional oversight authority, the head of the International Academy of Compounding Pharmacists disputed the need for new legislation to oversee the compounding industry. In testimony before the Senate last Thursday, the lobbyist said that NECC was operating as a “rogue drug manufacturer” and blamed federal regulators for not shutting down the company earlier.

As we recently reported, contamination problems like those at NECC are not isolated incidents. In fact, according to a New York Times article, “contamination and shoddy practices extend well beyond the loosely regulated compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis.”

In the past three years, six of the major manufacturers of sterile injectable drugs have been issued warnings by the FDA about serious violations of manufacturing rules, says that the Times article. These manufacturing facilities are subject to rigorous inspections by the federal government, whereas compounding pharmacies are generally overseen by the states.

Drug manufacturers, including compounding companies like NECC, have an obligation to ensure that the drugs they are manufacturing are safe. When a user of an unsafe pharmaceutical drug is injured as a result of taking the drug, he or she may be entitled to compensation for injuries suffered in a personal injury or product liability lawsuit.

The Chicago unsafe pharmaceutical attorneys at Ankin Law Offices, LLC have considerable experience representing clients in a wide variety of personal injury and product liability lawsuits, including class actions and lawsuits based on unsafe pharmaceutical drugs. Contact the skilled Chicago unsafe pharmaceutical drug law firm of Ankin Law Offices, LLC at (312) 600-0000 to discuss a possible personal injury or product liability lawsuit.