lyzed over the agency's legal authority over compounding. As a Senate
committee staff report would later admit, enforcement "proved to be
complicated. ...The jurisdictional issues had become so unclear that
the agency appeared to be unable to balance the risk of litigation
against the public health risk."
The troubles continue
In 2007, FDA's concerns about NECC and Avastin came true. A patient
administered NECC Avastin developed severe endophthalmitis. FDA
took no action.
Later in 2007, a pain specialist complained that some vials of NECC
betamethasone were discolored, with floating particles. He discarded
those and used the rest, but then more than 100 patients began com-
plaining of pain and flu-like symptoms. He identified 3 lots of medica-
tion and provided FDA one to test. It cultured negative. The matter
ended there. FDA did nothing.
In 2008, a Los Angeles patient had to be hospitalized after receiving
NECC IV phosphatidylcholine. After infusion, the patient complained of
a burning sensation and his arm swelled up. He vomited and urinated
blood, and he couldn't swallow food or liquid. After 3 ER visits, a physi-
cian found blood clots in his arm and hand. FDA analyzed a sample of
the drug and found it to be too strong, but took no action.
In 2011, the Colorado Board of Pharmacy complained to the FDA
that NECC was sending hyuloronidase to a hospital without patient
Rx's. In a cease and desist order, the board demanded that NECC stop
distribution in the state. The FDA suggested contacting the
Massachusetts Board of Pharmacy. The Colorado board did so, and
director James Coffey said the board would respond "as soon as pos-
sible." Mr. Coffey forwarded the message on to the board's attorney,
but ultimately did not order an investigation. He was later fired.
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