Uptick In Contaminated Drugs Recently Prompts FDA To Revamp Rules Governing How Medicines Are Manufactured
Currently, the FDA mostly relies on the industry to police itself, only sporadically inspecting manufacturing sites, but that approach has been strained by an increasing proportion of drug ingredients made in places like China or India. The proposed rule changes will focus on the raw materials used to produce drugs. News on medical devices and vaping comes out of the FDA as well.
Bloomberg:
Are Generic Drugs Safe? FDA Moves To Regulate Tainted Pills
U.S. regulators plan to revamp rules governing how medicines are manufactured, in an effort to ensure the safety of the nation's drug supply as recalls of contaminated imports from developing countries widen. "We’ve seen a lot of instances of adulterated products — contamination, impurities — recently,” said Food and Drug Administration Commissioner Scott Gottlieb, who plans to leave his post next month, in an interview. “The underlying causes have been traced back to manufacturing, inadequate quality controls and generally poor management oversight.” (Edney, 3/27)
Kaiser Health News:
FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices
FDA Commissioner Scott Gottlieb announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices. “We’re now prioritizing making ALL of this data available,” Gottlieb tweeted. (Jewett, 3/27)
Kaiser Health News:
Health Officials’ Plug For Next FDA Chief: Go Big On E-Cig Regulation
In an almost uniform response to the impending exit of Food and Drug Administration Commissioner Scott Gottlieb, city and county public health officials are urging the Trump administration to go bigger in its response to adolescents’ growing use of e-cigarettes. The issue, they say, is reaching crisis levels and many worry the FDA’s much-touted efforts are falling short. (Luthra, 3/28)
WBUR:
FDA's Gottlieb: More Kids Vaping 'Changes The Equation' For E-Cig Regulation
In his almost two years as FDA Commissioner, Scott Gottlieb has overseen a crackdown on the tobacco industry and on electronic cigarettes. It's an effort he hopes the agency will continue after he steps down in April. That's because, he says, of increased e-cigarette use among America's youth. (Inskeep, 3/27)
