New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs
Pandemics like COVID-19 certainly require the prompt approval of treatments, but efficacy and safety should not come at the cost of speed.
Drug Safety
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Read more: Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey
By Robert Field What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.” Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical…
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Read more: Generics, Bioequivalence, and Justice Generics, Bioequivalence, and Justice
By Matthew L Baum I have written previously on this blog about morally modifying technologies (here and here), which by definition work no better than existing technologies but enable the side-stepping of a moral tension associated with the first technology. Generic pharmaceuticals are a particularly well-known and widely endorsed form of morally modifying technology: they have…
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Read more: Regulating Compounding Pharmacies: Why An Increased FDA Role Shouldn’t Be Our Default Option Regulating Compounding Pharmacies: Why An Increased FDA Role Shouldn’t Be Our Default Option
By Patrick O’Leary A friend and I were having a conversation about health policy the other day when he observed that drug regulators like FDA face an impossible task in terms of public expectations: as consumers, we expect the drugs we take to be 100% safe, 100% of the time. Of course, no regulator, no…