Updated February 28, 2019 | Drug Injuries
Blog FDA Regulatory Authority Over Compounding Pharmacies UnclearRequest a Free Consultation
A deadly fungal meningitis outbreak that was linked to spinal steroid injections contaminated at a Massachusetts compounding facility has some lawmakers calling for increased federal oversight over pharmacies and other compounding facilities. Deborah Autor, Deputy Regulatory Commissioner at the Food and Drug Administration (FDA), said it is often difficult to determine exactly where the agency’s authority lies with regard to the regulation of specialty pharmacies. In response to the fungal meningitis outbreak, some members of Congress have stated they intend to introduce legislation that would provide the FDA with greater authority over compounding pharmacies.
Compounding facilities are specialized pharmacies that create custom drugs based on the needs of individual patients. Such facilities alter the dosage, physical form, ingredients, and other drug properties on an as-needed basis. Compounding facilities also provide pharmaceuticals that are not normally available commercially to doctors and medical facilities. The industry reportedly includes approximately 7,500 pharmacies that generate as much as $3 billion in revenue per year. Still, drugs created at a compounding facility are not subject to FDA review before they reach patients.
All pharmacies are regulated by a state board. When the FDA was created in 1938, the agency was only provided with authority over drug manufacturers. Not long after, pharmaceuticals created by drug manufacturers became the primary producers of prescription medications.
In the 1990s, however, the number of compounding pharmacies throughout the nation purportedly began to increase. Over time, many compounding facilities stopped creating drugs for individual patients and began to create large quantities of pharmaceutical products for commercial sale. Regulators for the FDA reportedly began to examine the pharmacies more closely in order to determine whether the facilities were simply engaging in unregulated drug manufacturing. Still, several attempts made by lawmakers to extend the FDA’s regulatory authority were unsuccessful.
The recent fungal meningitis outbreak is not the first time compounding pharmacies have been accused of injuring patients with contaminated drugs. In 2005, two individuals were allegedly blinded by a drug created at a compounding facility. Three people were reportedly killed in both 2005 and 2006 by compounded drugs. In early 2012, 33 patients in seven states came down with eye infections after using drugs that were purportedly created at a compounding pharmacy.
Investigators from the Centers for Disease Control and Prevention (CDC) have linked the fungal meningitis outbreak to the New England Compounding Center (NECC), located in Framingham, Massachusetts. Since the outbreak began, at least 200 people in 14 states developed the rare disease and 15 people have died as a result of infection.
Many compounding pharmacy experts believe NECC no longer operates as a compounding facility and has crossed the line into the unauthorized manufacture of drugs. In 2006, the FDA issued a warning letter to the company for selling a drug for general distribution instead of based on individual patient prescriptions. Still, the agency failed to re-inspect NECC’s facility.
According to FDA officials, the agency faces a number of challenges in regulating compounding facilities. The International Academy of Compounding Pharmacists has reportedly spent at least $1 million over the last ten years to defeat Congressional measures aimed at federal regulation of compounding facilities. Additionally, portions of a 1997 law that tasked the FDA with compounding facility oversight in limited instances were ruled unconstitutional by the United States Supreme Court. A 2003 attempt to create an FDA advisory committee focused on compounding pharmacy oversight was also allegedly thwarted.
Former Chief Counsel for the FDA, Sheldon Bradshaw, argues that the FDA has sufficient authority to regulate facilities like NECC. Bradshaw stated he was shocked by the claims of some FDA officials that the agency lacks authority to act against the compounding facility. It will be interesting to see whether the FDA is tasked with additional regulatory powers with regard to pharmacies and other compounding facilities in the future.
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