Margaret Hamburg, the new FDA sheriff, and her deputy, Joshua Sharfstein, have laid out a public health manifesto for the agency in the Obama era. No big shocker, given their previous jobs as activist health officials in New York and Baltimore, respectively.
Photo by davidsonscott15 via Flickr
If you’re interested in the details, check out their piece published online by the New England Journal of Medicine. Don’t overlook the lone footnote in the piece, a reference to a Supreme Court decision in 1969 that affirmed the FDA’s broad authority and its constant “overriding purpose”: the protection of public health.
The decision four decades ago came in a case that challenged the FDA’s authority to regulate as a drug a testing disc used to guide antibiotic therapy. The legal kerfuffle predates a 1976 law that spelled out the agency’s authority over medical devices.
The Supremes ruled the agency could treat the disc as a drug, reversing a lower court’s view, and in the process affirmed the FDA’s wide latitude in pursuing its mission.
As the Supremes put it:
[W]e are all the more convinced that we must give effect to congressional intent in view of the well accepted principle that remedial legislation such as the Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the Act’s overriding purpose to protect the public health….
From there, it’s not a big leap for FDA to regulate Cheerios as a drug.
