Meningitis outbreak sparks DeLauro to introduce legislation to oversee pharmacies
According to a release issued by DeLauro, compounding pharmacies are "at the root of the current fungal meningitis outbreak that has killed 11 people and sickened 119 in nine states." Compounding pharmacies create customized versions of medicine for specific patients, such as the estimated 17,000 steroid injections tied to the outbreak.
According to the release, such pharmacies are licensed and overseen by a patchwork of state agencies and the FDA’s guidance to states on licensing such pharmacies was last updated in 2002. The pharmacy that produced the potentially contaminated drug responsible for the current outbreak has surrendered its license to the Massachusetts State Board of Pharmacy and all compounds from the facility have been recalled.
DeLauro also sent a letter to Health and Human Services Secretary Kathleen Sebelius requesting information about the gaps in our drug safety system posed by compounded products and the need to better protect patients, including those enrolled in Medicare. “I believe this outbreak and corresponding recall make clear that strong Federal authority is needed over these large scale compounding pharmacies to ensure that patients receive safe and effective drugs, that we better monitor adverse events associated with these drugs, and that there is a single entity responsible for verifying appropriate marketing and safe drug production,” she wrote. “It is also critical that Federal and State partners responsible for this oversight have the resources and capacity needed to complete this work.”
DeLauro is a senior Democrat on the House of Representatives committee that funds the FDA and a longtime champion for strengthening oversight responsibilities and increased funding for the agency. Details on the recall may be found here and information on the fungal meningitis outbreak may be found here.
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