The Food and Drug Administration says it
doesn’t have the power it needs to control compounding pharmacies that have
expanded out of their traditional one-patient-at-a-time role to making
mass drugs.
But consumer advocates say a recent crackdown by the agency
shows it most certainly can – and should. A spate of recent FDA inspections
have shown that the dirty conditions that led to an outbreak of fungal
meningitis that killed 51 people and sickened more than 700 are anything but
rare at pharmacies that mix up what are supposed to be “sterile” injectable
drugs.
“We are currently deploying resources to work with states to
inspect certain state-licensed pharmacies that produce sterile drug products
that we believe may present the highest risk,” FDA commissioner Dr. Margaret
Hamburg writes in her latest
blog entry. “Over the past two months, we have inspected over 30 facilities
and will continue to work to protect public health.”
Luckily, so far, there’s not been another outbreak of illness
like the one traced to the New England Compounding Center (NECC), in which 51
people have died of fungal meningitis and more than 700 infected after receiving
contaminated injection steroids.
“We haven’t seen any other large-scale scale compounding
outbreaks,” Dr. Michael Bell, acting director of the division of health care
quality promotion at the Centers for Disease Control and Prevention, told NBC
News. He says there’s a steady stream of requests from states to check,
however.
The FDA is openly telling the pharmacies and drug
manufacturers it regulates that things have changed since the outbreak tied to
NECC. Hamburg was questioned by both House and Senate committees about how the
incident could even have happened.
“They appear to have the authority to take actions against
companies that engage in drug manufacturing,” Carome said. “What we are going to
have to wait to see is will they stand behind the citations of violations they
are making,” he added. “That is what they have failed to do previously.
Hopefully it’s not just for show.”
Currently, the FDA regulates drug manufacturers, while state
boards regulate pharmacies, including compounding pharmacies. But the line
between what is a manufacturer and what is a compounding pharmacy can be
blurry.
Compounding pharmacies are supposed to mix prescriptions one
at a time, on a per-patient basis. But there’s so much demand for special
formulations that hundreds of these compounders have started large-scale
production. Now, they closely resemble drug manufacturers – but without the very
strict oversight and long list of sterility requirements that manufacturers must
follow.
Jefferson says the crackdown hasn't gone entirely smoothly.
"We still run into situations where a facility has not cooperated with us," she
said. "We might not be able to take samples. They might say, 'No, you can't see
this.'" Then FDA has to seek help from state authorities.
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