EPA Targets Toxic Pollution From Medical Device Sterilizers
The Environmental Protection Agency is proposing tougher standards on pollution from several chemicals like ethylene oxide, but some in the industry are warning of potential disruption to supplies of safe medical equipment. Also: lead testing, Makena, weight loss drugs, and more.
The Washington Post:
EPA Seeks To Restrict A Toxic Medical Device Sterilizer
Acting in response to community health experts and environmental justice advocates, the Environmental Protection Agency is proposing tougher standards on pollution from several toxic chemicals, including ethylene oxide, widely used for sterilizing medical equipment and other purposes. But parts of the health-care and chemical industries are warning that these Biden administration rule changes could disrupt the supply of safe medical equipment, affecting hospitals and clinics nationwide. (Puko, 4/6)
In other pharmaceutical news —
The Boston Globe:
State Told Physicians To Stop Using Magellan Diagnostics Lead-Testing Devices In 2017 And ′21
The problems at Magellan Diagnostics in Billerica first became public in 2017 when the Food and Drug Administration warned that the company, self-marketed as “the most trusted name in lead testing,” was having serious issues with some of its devices returning false results. Six years later, the scope of the problem with the lead tests resurfaced this week with the arrest of three former Magellan executives on wire fraud and other charges for allegedly hiding the issue from regulators and knowingly selling defective machines. (Stoico, Ellement, Freyer and Lazar, 4/6)
AP:
FDA Forces Unproven Premature Birth Drug Makena Off Market
The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women. The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. The medication was the only drug approved in the U.S. to help reduce the risk of early births in women with a history of preterm deliveries. (Perrone, 4/6)
Stat:
Weight Loss Drug Ads: Telehealth Wades Into A Regulatory Gray Area
They’ve swiftly caught the attention of subway goers: splashy ads plastered on train station walls and turnstiles across New York by telehealth companies promoting controversial weight loss medications like Wegovy by name. Companies including Ro and Calibrate have capitalized on the new drugs by launching telehealth services dedicated to prescribing Wegovy and Ozempic, which patients inject themselves to treat obesity. Novo Nordisk’s drug Wegovy is FDA-approved for weight loss in adults, while the company’s drug Ozempic is approved to treat diabetes but is also prescribed off-label for weight loss. (Ravindranath, 4/6)
Atlanta Journal-Constitution:
Upcoming Drug Take Back Day Will Collect Unused Prescription Medications
Police departments across the region will be leading efforts to collect unused and expired prescription drugs during the U.S. Drug Enforcement Administration’s National Prescription Drug Take Back Day later this month. The event is held on April 22 and allows people to drop off medications at participating police departments or other locations from 10 a.m. until 2 p.m. (Murchison, 4/6)
