Showing posts with label 2013 (As Prepared for Delivery). Show all posts
Showing posts with label 2013 (As Prepared for Delivery). Show all posts

Tuesday, July 16, 2013

Opening Statement of the Honorable Joe Pitts Subcommittee on Health Hearing on “Reforming the Drug Compounding Regulatory Framework” June 16, 2013 (As Prepared for Delivery)


As we all know, in the summer and fall of 2012, a Massachusetts company, the New England
Compounding Center (NECC), shipped over 17,000 vials of an injectable steroid solution from three
contaminated lots to health care facilities across the country.
After receiving injections of NECC’s contaminated steroid, over 50 people died from complications
associated with fungal meningitis, and 700 others were stricken with meningitis or other persistent fungal
infections.
The outbreak ranks as one of the worst public health crises associated with contaminated drugs in the
history of the United States.
Shortly after the contamination came to light, the committee began an investigation into the matter,
requesting documents from the Food and Drug Administration (FDA) and the Massachusetts Department
of Public Health; examining whether the outbreak could have prevented and reviewing existing federal
and state regulatory authority over compounding pharmacies acting as manufacturers.
Both this subcommittee and the Oversight and Investigations Subcommittee have held multiple hearings
on the issues surrounding compounded drugs.
Today’s witnesses are here to discuss three legislative proposals released since the outbreak, including a
discussion draft authored by my colleague Morgan Griffith.
The Griffith draft includes targeted provisions that both clarify FDA’s authority as it relates to Section 503
of the Food, Drug, and Cosmetic Act while ensuring that traditional compounding remains within the
purview of state boards of pharmacy.