The fungal meningitis outbreak related to a compounding pharmacy’s production of methylprednisolone acetate for epidural injection has reached 354 cases and 25 deaths according to the CDC. As I reported earlier, the reasons for the outbreak are multifold, from lax regulation of the compounding pharmacy, which are pharmacies that mix approved drugs into new forms with additional, supposedly inert ingredients, to meet the needs of patients, to a procedure that is unsupported by clinical research, to pain management physicians who were trying to save a few dollars by using compounded drugs.
The New England Compounding Center (website has been replaced by a news release) is the center of attention for this outbreak, and because the FDA’s authority in regulating these types of pharmacies is limited, the state of Massachusetts has decided to step up it’s efforts in regulating, and if necessary, shutting down some of these pharmacies if they violate state and federal regulations. The New York Times has reported that Massachusetts shut down Infusion Resource in Waltham, MA, after “after a surprise inspection last week found conditions that called into question the sterility of its products, state officials said Sunday.”
Gov. Deval Patrick ordered the state’s Board of Registration in Pharmacy to immediately begin surprise inspections of compounding pharmacies that prepare injectable sterile medications. According to the New York Times article,
There are 25 such pharmacies in Massachusetts, and Mr. Patrick has acknowledged that the state rules governing them were insufficient. Although the Food and Drug Administration can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.
At the news conference on Sunday, Dr. Lauren Smith, the interim commissioner of the Massachusetts Department of Public Health, said the state was bringing on five additional inspectors to help with unannounced visits to compounding pharmacies. The goal is to inspect all of them by Jan. 1, she added.
A number of public health advocates have called for increased FDA regulatory power over compounding pharmacies for many years, warning that these pharmacies are not currently subject to the FDA’s oversight on manufacturing, quality and efficacy. Thus, they are easily able to distribute products like the tainted steroids that pose serious public health risks without worrying about any type of significant oversight. Some members of Congress have already called for a criminal investigation into the meningitis outbreak.
Hopefully, Massachusetts will lead the way in fixing this issue, but this should be the FDA’s responsibility. Congress will probably have to revise or add new regulations for the FDA to really clamp down on this problem, or it will happen again.
- Staal JB, de Bie RA, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine (Phila Pa 1976). 2009 Jan 1;34(1):49-59. Review. PubMed PMID: 19127161.
- Goodnough A. Massachusetts Shuts Down Another Compounder. New York Times, October 28, 2012.