Although most people probably couldn’t have defined the term, compounding pharmacies hit the news in a big way in September 2012, when a deadly outbreak of fungal meningitis, which to date has caused 63 deaths and sickened 749 other people, was traced to contaminated steroids produced by the New England Compounding Center (NECC).
Pharmacists have traditionally had the right to make custom-blended drug compounds, designed and prescribed for the specific needs of particular patients. For example, the injectable methylprednisolone acetate for chronic back and joint pain that the Framingham, Massachusetts-based NECC produced was considered a customized product because it did not contain an alcohol preservative, unlike commercial products from other makers. Unfortunately, three lots of the NECC products also contained bacteria that caused serious and frequently lethal fungal meningitis.
The NECC case was the largest, but far from the only case of potentially life-threatening illnesses linked to products made by lightly-regulated compounding pharmacies. In the most recent case, on August 9, central Texas-based Specialty Compounding, LLC recalled all of its unexpired sterile medicines dispensed since May 9. The action came after two patients at Corpus Christi hospitals died, and at least 15 more developed bloodstream infections from Rhodococcus equi bacteria, after having IV infusions of calcium gluconate made by the compounding firm to treat low calcium levels. Even before the NECC-linked outbreak, 33 eye-surgery patients across seven states contracted fungal infections after using an injectable product from a Florida compounding firm, and most of those patients as a result lost at least some of their vision.
Since compounding pharmacies traditionally have been small-volume operations making specialized products prescribed for particular, often local, patients, they have long been regulated by state pharmacy boards, not by the U.S. Food and Drug Administration (FDA). But the emergence of large-scale drug compounders like NECC and Specialty Compounding has led some in Congress to call for legislation to bring them under the same rules FDA enforces on other large-scale drug makers. That would force them to follow FDA’s good-manufacturing process rules, require them to tell FDA when they learn of adverse drug effects, mandate pre-sale evidence of drug safety and effectiveness, and allow FDA plant inspections.
In the NECC case, the company sold its steroid injectables in 23 states, reportedly soliciting bulk orders from clinics, not just filling individual prescriptions, but was only regulated by Massachusetts pharmacy board. The FDA did not inspect NECC, approve its products, or require automatic notice of adverse effects. After the meningitis outbreak, a Massachusetts health official said NECC had manufactured drugs in unsanitary conditions and violated restrictions in its pharmacy license. Now stripped of its state license and seeking Chapter 11 bankruptcy, NECC has also been sued by over 400 plaintiffs.
For its part, the FDA says a split among federal appellate courts has clouded its authority to regulate large-scale compounding firms, and has called for Congress to adopt stronger controls. Proponents argue large-scale compounders act more like drug manufacturers than compounding pharmacies, and their nationwide operations are beyond states’ regulatory capabilities.
This spring, the Senate Health, Education, Labor, and Pensions Committee unanimously cleared a bill (S. 959), the Pharmaceutical Quality, Security, and Accountability Act, to expand FDA’s powers to regulate drug compounding. The measure would spell out distinctions between traditional compounders and large-scale compounders, and require the latter to register with the FDA and be subject to agency inspections.
If you or a loved one has been harmed by a dangerous or defect drug, protect your rights by getting in touch with a New York pharmaceutical injury attorney.
