[Ip-health] FDA to allow cheaper preterm baby drug (Washington Post)
gabriel.j.michael at gmail.com
Wed Mar 30 11:38:49 PDT 2011
FDA to allow cheaper preterm baby drug
By Rob Stein, Wednesday, March 30, 12:30 PM
The Food and Drug Administration on Wednesday disputed a drug
company’s claim that pharmacies can no longer produce less expensive
versions of a drug long used to reduce the risk that women will give
The statement was aimed at defusing an intense controversy that
erupted after the agency approved the drug Makena to prevent preterm
births. Makena’s owner, KV Pharmaceutical of St. Louis, is charging
$1,500 a dose for the drug. The same compound had been available for
years for about $10 to $20 a dose.
The statement came a day after The Washington Post reported the
intense criticism that has arisen over Makena. After word of Makena’s
price began to spread, Internet sites for pregnant women became filled
with angry commentary. Some created Facebook pages lambasting KV. The
high price also drew harsh criticism from several members of Congress,
as well as the American College of Obstetricians and Gynecologists,
the American Academy of Pediatrics and the Society for Maternal-Fetal
But in a statement Wednesday, the FDA said it would not exercise its
authority to prevent pharmacies from producing “compounded” versions
of the drug unless evidence emerged that patient safety was at risk.
“FDA understands that the manufacturer of Makena, KV Pharmaceuticals,
has sent letters to pharmacists indicating that FDA will no longer
exercise enforcement discretion with regard to compounded versions of
Makena. This is not correct,” FDA spokeswoman Beth Martino said in a
“In order to support access to this important drug, at this time and
under this unique situation, FDA does not intend to take enforcement
action against pharmacies that compound hydroxyprogesterone caproate
[the active ingredient in Makena] based on a valid prescription for an
individually identified patient unless the compounded products are
unsafe, of substandard quality, or are not being compounded in
accordance with appropriate standards for compounding sterile
products,” Martino said. “As always, FDA may at any time revisit a
decision to exercise enforcement discretion.”
The FDA’s announcement was praised by advocates for pregnant women.
“This is wonderful news and a victory for preemie families that have
suffered significant amounts of trauma more than most people can
understand,” said Mary Beth Hazelgrove, executive director of the
group Preemies Today.
More than 500,000 of the 4.2 million women who have babies each year
give birth prematurely, and many of the babies don’t survive. Those
who do are at increased risk for many health problems, including
mental retardation, cerebral palsy and autism.
A form of the hormone progesterone, known as 17P, for years had been
used to reduce the risk of preterm birth, but it fell out of favor
after the manufacturing company stopped making it. In 2003, a National
Institutes of Health study showed that 17P could cut the risk of
preterm delivery if given in the first 16 to 24 weeks of pregnancy.
That led to a resurgence in the use of 17P. Because no companies
marketed the drug, women obtained it cheaply from compounding
pharmacies, which produce individual batches of drugs for patients.
But doctors and regulators had long worried about the purity and
consistency of the compounded drug and were pleased when KV won FDA’s
imprimatur for a well-studied version, which the company is selling as
The approval of Makena in February gave the company seven years of
exclusive rights, and KV immediately fired off letters to compounding
pharmacies, warning that they could no longer sell their versions of
Because the drug must be given for about 20 weeks, Makena would cost
about $30,000 for each at-risk pregnancy, which could add more than $4
billion to the nation’s health-care bill.
KV’s stock price was down Wednesday in early trading.
steinr at washpost.com
More information about the Ip-health