NEJM: Bizarro Regulatory Suggestions
The two leading perspective articles in last week's New England Journal of Medicine are striking examples of the bizarre call for regulation when none is need.
The first, Kevin Outterson's Regulating Compounding Pharmacies after NECC is a lawyer's take on changes in the regulatory requirements after the New England Compounding Center fiasco in which hundreds of people were infected with rare fungal disease due to contaminated steroids. Compounding pharmacies are an interesting entity in modern medicine. In a time when drug companies and generic manufacturers are stamping out medicines left and right, it is the compounding pharmacy that is allowed to take existing medicines and combine them (or redose them) due to individual physician/patient needs. Due to their unique role as the individual practice of pharmacy, they have avoided wide-scale regulation like their manufacturing counterparts. Apparently Congress is already discussing new federal regulations.
However, as Outterson clea…
