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