WASHINGTON, DC - The Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining the U.S. Food and Drug Administration’s (FDA) implementation of Title I of the Drug Quality and Security Act (DQSA).
DQSA was enacted nearly five years ago in the wake of the fungal meningitis outbreak caused by the New England Compounding Center. At that time, the DQSA established heightened safeguards for compounded medications, as well as new avenues for entities to engage in compounding of medications.
Detailing the 2012 fungal meningitis outbreak, Chairman Burgess categorized it as “…one of the worst and most fatal drug safety incidents in U.S. history, where more than 750 people developed fungal infections in 20 states and over 60 people died subsequently."
Witnesses begin to deliver their opening statements.
Ms. Nancy Dargan shared her personal story about being among the 750 individuals to develop a fungal infection in the 2012 outbreak. Sadly, her devastating story is not over.
“Today, five years after this tragedy began, I still have recurring symptoms and numerous side effects," stated Ms. Dargan. “I walk with a limp and cannot get an orthopedic surgeon to consider replacing my right hip because there are still fungal pockets on my bones. My pain levels are always elevated. My disease and treatment have made me vulnerable to opportunistic infections that have attacked my kidneys and sinuses. I continue to suffer from short term memory loss, and it is getting worse year after year."
FDA Commissioner Scott Gottlieb, M.D. talked about the impact of the 2012 outbreak, saying, “This outbreak underscored the need for improvement in compounding practices, as well as the need for more robust oversight of compounders, close federal and state collaboration, and a clear legal framework that would provide for lawful compounding to meet patients’ medical needs, while also providing FDA with tools to address unlawful compounding practices that threaten public health."
Commissioner Gottlieb responds to member questions.
Commissioner Gottlieb also highlighted the goals of DQSA and the role the FDA has taken in the years since its passage, stating, “During the last five years, we have made great strides in DQSA implementation through policy development, oversight, and stakeholder outreach."
Mr. Jacob Olson, President and CEO, Skywalk Pharmacy, on behalf of National Community Pharmacists Association (NCPA), stated, “All compounding pharmacies should be held to the same standards so that patients have assurance that they are receiving the same quality regardless of whether the compounded medication is from a hospital or community pharmacy." He also added, “It is essential that patient access to vital compounded medications is preserved in the patient-physician-pharmacist triad. Providers must be able to choose the best medication for the patient’s well-being."
