A year into a fungal meningitis outbreak that has killed or sickened more than 700 Americans, federal lawmakers and health authorities still struggle to find a way to keep it from happening again.
Congressional staffers from the U.S. House and Senate have negotiated over the last two weeks, consulting with health advocates and industry lobbyists, on legislative language to best protect Americans from contaminated compounded drugs. Too often those drugs are produced by large compounding pharmacies that ship huge quantities of medications between states without prescriptions and without federal oversight.
One such pharmacy in Massachusetts compounded the contaminated steroid injections that have killed 64 people in the last year.
Voters strongly support a clearer and more invasive role for federal drug safety regulators in overseeing the practice of pharmacy compounding, a new poll has found.
In the survey of 800 registered voters, 77 percent of respondents said they would support giving the U.S. Food and Drug Administration more authority to regulate compounded drugs and compounding pharmacies.
The poll was commissioned by the Working Group on Pharmaceutical Safety, a coalition of drug manufacturers and health advocates that supports stronger federal oversight over pharmacies that compound large amounts of drugs outside of FDA regulations.
Traditional compounding is the pharmacy practice of mixing medications from scratch to meet the individual needs of a particular patient. In recent years, however, public health advocates have become alarmed as some pharmacies have grown to resemble drug manufacturers. But conventional drugmakers must comply with strict federal rules ensuring their products are safe and effective, standards that do not apply to compounders.
The risks and potential dangers of pharmacy compounding first were exposed in a Kansas City Star series more than a decade ago.
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