By STEPHANIE GLEASON
K-V Pharmaceutical Co., KVPHQ +21.97%a
small drug maker, landed in bankruptcy court last year amid disappointing sales
of its flagship medicine Makena and an outcry over the drug's high price.
Today, sales of Makena, used to prevent preterm birth,
are surging.
K-V slashed the price of the drug by half. But a bigger
reason for the gains, say many doctors, is an aggressive K-V campaign touting
Makena as a safe alternative to cheaper versions of the drug made by compounding
pharmacies.
Compounders, lightly regulated pharmacies that
custom-mix drugs, have long provided a less expensive version of the main
ingredient in Makena. But a string of meningitis deaths late last year linked to
pain medicine from a Massachusetts compounding pharmacy medicine raised concerns
about the safety of such drugs. Compounded medicines aren't approved by the Food
and Drug Administration.
Doctors say K-V representatives have been pressing them
to switch to Makena by reminding them of the potential for malpractice lawsuits
should their patients fall ill after taking a drug formulated by a
compounder.
"They've been in doctors' faces a lot more about the
possible harm of compounded medications," said Armando Fuentes, a maternal-fetal
medicine specialist at Children's Hospital Central California. "They've really
ratcheted up their marketing," he said.
K-V in a statement said the recent "tragic cases"
highlighted a need for information about the differences between compounded
medicines and those that carry FDA approval. The St. Louis-based company added,
"K-V is taking all responsible approaches to educate health-care providers to
help avoid costly and painful unintended consequences" for patients and
providers.
Compounders, for their part, say the compounded version
is as safe as Makena. "We cannot conclude that there is any disparity in quality between this manufactured drug and the compounded
alternative," said a representative of the International Academy of Compounding
Pharmacists, David Ball, citing a June 2012 FDA analysis that tested 16 samples
of the compound and found them potent and pure.
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