[Ip-health] Washington Post: Critics slam cost of FDA-approved drug to prevent preterm births

Thiru Balasubramaniam thiru at keionline.org
Tue Mar 29 00:50:03 PDT 2011


Critics slam cost of FDA-approved drug to prevent preterm births

By Rob Stein, Monday, March 28, 9:07 PM
When a drug to prevent babies from being born too early won federal  
approval in February, many doctors, pregnant women and others cheered  
the step as a major advance against a heartbreaking tragedy.

Then they saw the price tag.

The list price for the drug, Makena, turned out to be a stunning  
$1,500 per dose. That’s for a drug that must be injected every week  
for about 20 weeks, meaning it will cost about $30,000 per at-risk  
pregnancy. If every eligible American woman were to get Makena, the  
nation’s bloated annual health-care tab would swell by more than $4  

What really infuriates patients and doctors is that the same compound  
has been available for years at a fraction of the cost — about $10 or  
$20 a shot.

“It’s outrageous,” said Helain J. Landy, chairman of obstetrics and  
gynecology at Georgetown University Hospital. “Raising the cost of  
each injection from around $20 to $1,500 is ludicrous.”

The company that owns Makena, KV Pharmaceutical of St. Louis, says the  
price is reasonable, given that it is spending more than $200 million  
to develop the drug and conduct follow-up studies that the Food and  
Drug Administration demands, and because of the savings resulting from  
preventing preterm births. Through a subsidiary, Ther-Rx Corp., the  
company created a program to help women who can’t afford it.

“Ther-Rx is fundamentally committed to the community of women,  
children and families it serves and has been carefully listening to  
all stakeholders following the announcement of the list price for  
Makena,” the company said in an e-mail.

Critics are challenging that claim, noting that the main study used to  
demonstrate the drug’s effectiveness was a $5 million project  
conducted by the National Institutes of Health — paid by taxpayers.

“It’s not like this drug is something they invented,” said George  
Saade, president of the Society for Maternal-Fetal Medicine, which,  
along with the American Congress of Obstetricians and Gynecologists  
(ACOG) and the American Academy of Pediatrics, sent KV a letter  
protesting Makena’s price. “I think the company is taking advantage of  
their FDA approval and their monopoly to make money.”

In addition to making the drug unaffordable for some women, experts  
fret about the added costs for insurers that choose to pay for it,  
especially Medicaid programs already being slashed in states  
struggling with deficits.

“I’m worried about the patients not being able to afford the  
medication. I’m worried about our health-care system not being able to  
afford to pay this kind of price for a medication. And I’m worried  
about a process that enabled a drug that was readily available to go  
on to be become very expensive,” said Hal C. Lawrence III, vice  
president of practice activities at ACOG.

The case has put a spotlight on the March of Dimes, which has received  
about $1 million in donations from Ther-Rx and praised Makena when it  
was approved, only to later criticize the price.

“They were clearly holding back the price until after the FDA approval  
process,” said Alan R. Fleischman, March of Dimes’s medical director.  
“When we found out, we were as outraged as everyone else.”

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 progesterone known as 17P was used for years to reduce the  
risk of preterm birth, but it fell out of favor after the  
manufacturing company stopped making it. In 2003, the NIH 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 produced individual batches for  

Doctors and regulators had long worried about the purity and  
consistency of the drug and were pleased when KV won FDA’s imprimatur  
for a well-studied version, which the company is selling as Makena.

The approval of Makena 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  

“Continuing to compound this product after FDA approval of Makena  
renders the compounded product subject to FDA enforcement for  
violating certain provisions of the Federal Food, Drug and Cosmetic  
Act, as well as FDA guidance,” the letter says.

After word of KV’s actions began to spread, Internet sites for  
pregnant women became filled with angry commentary. Some created  
Facebook pages lambasting KV.

“I think it’s disgusting,” said Della Leahy, 34, of Fairfax, who is  
taking 17P to prevent her fourth pregnancy from ending prematurely.  
Leahy has two children but lost a son in 2008 who was born  
prematurely. “It just seems like the company is out for a huge gain of  
money. It’s very upsetting.”

Each insurance company and state Medicaid program must decide whether  
to cover the drug. But even women whose insurance will pay could face  
thousands in out-of-pocket costs to satisfy co-payments and deductibles.

FDA officials said that they had no idea how much the company planned  
to charge for the drug and were surprised by the cost but that the  
agency has no power over pricing.

In an interview with The Washington Post on Friday, an FDA official  
said that, if requested, the agency could approve a lower-priced  
generic version of the drug for another use that doctors could  
prescribe “off label.”

In addition, the official said the agency would not prevent  
compounding pharmacies from continuing to provide 17P unless patient  
safety is thought to be at risk.

“We have our hands full pursuing our enforcement priorities,” said the  
official, who spoke on the condition of anonymity because of the  
sensitive nature of the issue. “And it’s not illegal for a physician  
to write a prescription for a compounded drug or for a patient to take  
a compounded drug. We certainly are concerned about access of patients  
to medication.”

Several members of Congress have sent letters to KV complaining about  
the price and demanding justification and have asked the Centers for  
Medicare and Medicaid Services and Federal Trade Commission for  

Outside experts said the FTC could sue KV if it concludes the company  
is illegally impairing competition.

“It threatens to extract significant competitive harm on extremely  
vulnerable pregnant women, and it threatens to significantly inflate  
health-care costs at a time when controlling health-care costs is a  
critical national priority,” said David Balto, a Washington antitrust  
lawyer who worked at the FTC.

steinr at washpost.com


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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