What do you suppose a Texas drug
compounding
company did after the Food and Drug Administration
(FDA) told it repeatedly
to recall all its potentially “life-threatening” drugs? Well, basically, NuVision
Pharmacy told
the FDA
to fuck off.
“NuVision Pharmacy is not recalling all sterile inject-
ables,” the company stated flatly on its website.
And the official FDA reaction? It admitted impotence.
The agency wrote in an August 16 press release that it “can-
not require NuVision to undertake such a recall.”
Congress, in its campaign-dollar-soaked wisdom, has not
granted the FDA the power to recall any drug—whether
manufactured by Big Pharma or compounded in a pharmacy.
Even if the product is proven dangerous, or made in viola-
tion of federal laws, the agency can only request compliance.
America’s thousands of “compounding pharmacies”
like NuVision slip through additional regulatory loopholes.
The category was established under now-outmoded rules
developed to regulate your local drug store. Barred from
“manufacturing” drugs, a compounder, by FDA definition,
just “combines, mixes, or alters ingredients in response to a
prescription, to create a medication tailored to the medical
needs of an individual patient”—someone who needs, say, a
custom-tailored dosage or formula without an allergen.
But hospitals, veterinarians, alternative practitioners and
traditional doctors bypass that definition by mass ordering
compounded drugs in “anticipation” of need—without a
specific prescription. Thus, compounding pharmacies have
expanded to fill the same role—and sometimes prescrip-
tions—as major drug manufacturers. Except they fall more
under state than federal oversight and regulation, don’t need
to register with the FDA or comply with its standards or
labeling requirements, and don’t need to submit their drugs
to the FDA for testing and approval processes before sale.
Dallas-based NuVision, founded by Gary Osborn, says it
is licensed in 38 states and boasts on its website: “Quality Be-
yond Reproach.” Beyond recall, yes. Beyond reproach? Not
so much. FDA inspectors found such a panoply of quality,
sterility and control violations at the facility that the agency
sent out a press release telling healthcare providers to quar-
antine and stop administering all NuVision sterile products.
To be fair, in April NuVision did voluntarily recall one
drug linked to “adverse reactions” including fever, flu-like
symptoms and injection site soreness. But among the drugs
NuVision still markets, which FDA inspectors “cannot guar-
antee for sterility,” are “cocktails” delivered by catheter to
treat bladder infections and impotence treatment injections
“easily delivered into the penis.”
NuVision defends its refusal to recall on its website: Since
it is a simple compounder, the FDA cannot legally hold it
to the same standards it sets for manufacturers, and, in any
case, third-party labs test “every lot of [its] sterile products.”
Even if true, this reassurance is less than ironclad. The inde-
pendent labs to which NuVision and other compounders
turn for quality-control testing have their own problems. On
August 21, the FDA issued a statement on Colorado-based
Front Range Laboratories, which does testing for more
than 100 compounders in 32 states, noting “concerns that
results obtained from Front Range are not reliable” when it
comes to sterility, dose accuracy and drug stability.
If your eyes are rolling back in your head, it’s because
this regulatory black hole is deep and stupid beyond
belief. But snap out of it, and keep reading—as if your
life depended on it.
And it did last year, for 14,000 people in 23 states who
were injected with a fungi-and bacteria-contaminated ste-
roid made by New England Compounding Center (NECC).
The drug sickened 749 people with fungal meningitis and
other infections; it killed 63.
And patients’ lives—and deaths—also depended on
compounded drugs made by ApothéCure and its sister
company SpectraPharm. Both pharmacies were headed by
NuVision’s founder Gary Osborn, and both were run out of
NuVision’s Dallas headquarters. In 2007, three people in the
Pacific Northwest died after being injected with colchicine,
compounded by ApothéCure and SpectraPharm. The drug
was 640 percent more potent than labeled. Osborn told an
Associated Press reporter that it was the first such incident
and, “You know what people say, stuff happens.”
Osborn should know. Two years before, ApothéCure’s
unproven chelation treatment for autism was implicated in
the death of a 5-year-old child in Pennsylvania.
As for sterile conditions, in 2010, ApothéCure was
“riddled with unsanitary conditions,” reported the
Washington Post after obtaining an internal audit. “Insect body
parts were found in ‘clean rooms’ [and] exposed pipe, wiring and
duct work, allowed ‘contaminants to flow over the sterile
suite and fall through the suspended ceiling,’” said the audit.
In 2012, federal and Texas courts ruled on the three Pacific
Northwest deaths. They found Osborn, ApothéCure and
SpectraPharm guilty of various charges, including substan-
dard practices, selling misbranded drugs, unlawfully mar-
keting dietary supplements to treat diseases and illegally
formulating an unauthorized painkiller that led to three deaths
in the Pacific Northwest. The court allowed Osborn to keep
his pharmacist license but imposed probation, a $100,000
fine and a 90-day house arrest, which shouldn’t be too
onerous in his $1.8 million, 5,000-square-foot, 5-bathroom
home in Far North Dallas. Nor will the six-figure fines on
ApothéCure make too deep a dent in its $10 million annual
earnings.
The ruling placed restrictions on ApothéCure—but not on NuVision.
Osborn founded the new company in 2010, in the midst
of bad press and the court proceedings— setting up shop in
the same building as ApothéCure.
On May 18, increasingly frustrated by NuVision’s recall
refusal, the FDA issued a stronger request. Then on July
26, the agency wrote NuVision that it was issuing a Class
I recall, its most serious advisory, used only when there
is “a reasonable probability ...[of] serious adverse health
consequences or death.” Calling all sterile products from
NuVision’s inadequately designed facility “adulterated,”
the recall was “necessary to protect the public health and
welfare” against the pharmacy’s possibly “life-threatening”
products, the FDA wrote.
NuVision, which did not return numerous calls and
emails from In These Times, reiterated on its website that the
FDA had no evidence “that our products lack sterility assur-
ance,” nor any authority in the matter, since compounders
are exempted from manufacturers’ stricter standards.
In August, four months after the original recall, the FDA
issued the 21st-century equivalent of putting a miscreant in
stocks in the village square. Its public shaming of NuVision
took the form of a news release detailing the compounder’s
recalcitrance and the agency’s inability to enforce a recall.
As for its threat to take “further regulatory action,” the
FDA acknowledged only that it “may seek enforcement
actions, such as seizure or injunction” when “appropriate.”
Spokesperson Christopher Kelly added in an email,
“We are speaking about our authority to take enforcement
action in a general sense only; this does not indicate a
specific intention to take those actions in this case. [Emphasis
in original.]” Kelly has not responded to other written
questions, and declined to talk on the record.
There are currently several proposals in Congress to
better define and regulate compounders—but, as Public
Citizen points out, they leave patients “at risk” since com-
pounding pharmacies would still be exempt from FDA
standards for drug manufacturers.
The compounding industry benefits from this ambiguous
status. It has used its lobbying clout to defeat or dilute state
and federal reform efforts. The stakes are high. Compound-
ing pharmacies make up between 1 and 3 percent of the $300
billion annual U.S. prescription drugs market, according to
the International Academy of Compounding Pharmacists.
The trade group spent $1.1 million from 2001 to 2012 on
lobbying, and bragged to members that it had helped defeat
a bill to increase FDA authority.
And since Medicare and private insurance companies of-
ten pay fixed reimbursements for drugs, docs and hospitals
may have a financial incentive to sell patients cheaper, less-
regulated compounded versions, and pocket the difference.
“The industry is more dangerous than people realize,” says
Doletta Sue Tuck-Richmond, who writes an intensively docu-
mented blog about the industry. “NuVision is an example of
how states have dropped the ball on enforcing. The feds have
stepped in, but don’t have power to do much beyond issuing
a warning letter and hoping that we pay attention.” |