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Statement of Nasima Hossain, U.S. PIRG public health advocate, on the Reforming the Drug Compounding Regulatory Framework Hearing in the U.S. House Energy and Commerce Subcommittee on Health.
“Compounding pharmacies— traditionally, facilities where medicines are altered to fit the medical needs of individual patients—are not currently subject to the same level of oversight and scrutiny as pharmaceutical companies, even when they behave like a conventional drug manufacturer by making drugs in bulk, in advance of a specific prescription, or shipping them across state lines. As documented in a recent U.S. PIRG report, this lack of oversight has led to many deaths and illnesses. These pharmacies do not conduct rigorous testing and research, nor do they adhere to the safe manufacturing processes that pharmaceutical companies must adhere to. Stronger rules could have prevented last fall’s fungal meningitis outbreak from tainted drugs, which killed 61 and sickened more than 700 people across the country.
“To allow the FDA to better protect the health and safety of the American people from unsafe compounded drugs in the marketplace, Congress must enact legislation that puts in place more complete public health regulations and safeguards. We must never repeat the tragedy of having contaminated and unsafe drugs on the market again.”
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