Higher First Amendment hurdles for public health regulation.

Boston University School of Law, Boston, USA.
New England Journal of Medicine (Impact Factor: 54.42). 08/2011; 365(7):e13. DOI: 10.1056/NEJMp1107614
Source: PubMed
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    ABSTRACT: In September 2012, news broke of a developing drug disaster in the United States. Health authorities had linked a fungal meningitis outbreak to a contaminated steroid made by a company called the New England Compounding Center. The contaminated steroid was a compounded drug that had not been approved by the Food and Drug Administration, differing from three others that had been approved in that it lacked preservatives present in those agents. Factory inspections revealed unsanitary conditions at NECC's drug production facility. By the time the source of the outbreak was identified, an estimated fourteen thousand people had been injected with the drug. As of December 2012, thirty-nine had died of meningitis, and hundreds more had been diagnosed with meningitis and other drug-related conditions. Many factors contributed to this disaster. One was a 2002 Supreme Court decision holding that a law prohibiting providers of compounded drugs from promoting their products through advertising and other means impermissibly restricted commercial speech.
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    ABSTRACT: ABSTRACT Compounding pharmacies serve a critical role in modern health care to meet special patient care needs. While the Food and Drug Administration (FDA) has clearly delineated jurisdiction over drug companies and products manufactured under Good Manufacturing Practice (GMP) regulations to ensure quality, potency and purity, compounding pharmacies are regulated by the State Boards and are not registered by the FDA. In the recent years, some compounding pharmacies acted like a manufacturer, preparing large amounts of injectable drugs with interstate activities. Multiple outbreaks have been linked to compounding pharmacies, including a recent outbreak of fungal meningitis related to contaminated methylprednisolone, exposing more than 14,000 patients in multiple states. This tragedy underscores the urgency of addressing safety related to compounding pharmacies. There is a call for action at the federal and state levels to set minimum production standards, impose new labeling conditions on compounded drugs, and require large scale compounders be regulated by the FDA. "Industrial" compounding must come under FDA oversight, require those pharmacies to meet GMP standards, and ensure quality and safe products for patient use. Moreover, compliance with the Institute for Safe Medication Practices 2011 recommendations that any type of sterile compounding must be in compliance with the United States Pharmacopoeia Chapter 797 guidelines will reduce the risk of patient harm from microbial contamination. Finally, other critical factors that require close attention include addressing injectable products compounded in hospitals and other outpatient healthcare centers. The FDA and State Boards of Pharmacy must be adequately funded to exercise the oversight effectively.
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