[Ip-health] FDA to allow cheaper preterm baby drug (Washington Post)

Gabriel Michael 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  
birth prematurely.

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

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