ST. LOUIS, June 18, 2012 /PRNewswire/ -- K-V
Pharmaceutical Company ("the Company") (NYSE: KV.A/KV.B) announced
today that the U.S. Food and Drug Administration (FDA) and the
Centers for Medicare & Medicaid Services (CMS) both issued
updated statements on Makena® that affirm the importance of the
only FDA-approved drug for treatment of women with a history of
preterm birth. Prior statements by both agencies had been
cited by some payers as the basis for denying patients' access to
FDA-approved Makena in favor of unapproved compounded
hydroxyprogesterone caproate (17P) formulations.
FDA's June 15, 2012 update
highlights:
- In a reversal of its March 30,
2011 statement, the "FDA emphasizes that it is applying its
normal enforcement policies for compounded drugs to compounded
hydroxyprogesterone caproate."
- "The compounding of any drug, including hydroxyprogesterone
caproate, should not exceed the scope of traditional pharmacy
compounding."
- "Compounding large volumes of drugs that are copies of
FDA-approved drugs circumvents important public health
requirements, including the Federal Food, Drug, and Cosmetic Act's
drug approval provisions."
- "…one factor that the agency considers in determining whether a
drug may be compounded is whether the prescribing practitioner has
determined that a compounded product is necessary for the
particular patient and would provide a significant difference for
the patient as compared to the FDA-approved commercially available
drug product."
- "The drugs that pharmacists compound (including compounded
hydroxyprogesterone caproate) are not FDA approved, which means
they do not undergo premarket review nor do they have an FDA
finding of safety and efficacy."
- For at least the third time in the past 15 months, FDA has
reiterated that "…approved drug products, such as Makena, provide a
greater assurance of safety and effectiveness than do compounded
products."
For more information about FDA and Pharmacy Compounding, please
see the following links:
- http://www.youtube.com/watch?v=kif_rmtIQb0
- http://www.fda.gov/OHRMS/DOCKETS/98fr/02D-0242_gdl0001.pdf
FDA's statement also summarized the results of its investigation
of a limited number of samples of compounded hydroxyprogesterone
caproate API and finished 17P, including the following:
- 100% (16 of 16) of the API samples procured and tested by FDA
failed Makena's standards for unidentified impurities.
According to FDA requirements, API of this quality is unsuitable
for use in Makena®.
- FDA also found potency and unidentified impurity issues in
compounded 17P finished goods samples. According to FDA
requirements, if Makena® were to have these deficiencies, it would
be considered adulterated.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070287.pdf
- FDA's testing of the compounded 17P samples provided by the
Company also confirmed variability in potency and purity.
In addition, the Company's previously reported research
found:
- That the primary source of hydroxyprogesterone caproate is
unregistered and/or uninspected manufacturing facilities in
China
- That one of seven samples of API from the original Chinese
manufacturers was not hydroxyprogesterone caproate, but was instead
glucose
More recently, the Company has identified and provided
information to the FDA relating to multiple instances of
intentionally mislabeled hydroxyprogesterone caproate API sourced
from multiple Chinese suppliers.
CMS's June 15, 2012
update:
In a related statement, CMS also issued an update, which
reiterated FDA's comments that approved drug products, such as
Makena, provide a greater assurance of safety and effectiveness
compared to compounded products, and also that the compounding of
any drug, including hydroxyprogesterone caproate, should not exceed
the scope of traditional pharmacy compounding. Additionally,
in its June 15 update, CMS:
- Reminded States of their "…responsibility to cover FDA-approved
products, such as Makena, that qualify as covered outpatient drugs
under the Medicaid drug rebate program."
- Pointed out with regard to drug coverage policies for their
insured beneficiaries that …"Any prior authorization procedures for
such drugs must be administered in accordance with Section 1927(d)
of the Social Security Act, without imposing unreasonable
conditions."
The Company has identified and informed CMS of certain States
that are acting contrary to these established policies by imposing
unreasonable conditions, including so-called "prior authorization"
procedures that have effectively denied Medicaid participants'
access to Makena. Based on the updated CMS statement of
June 15, 2012, we look forward to
these States promptly removing these unreasonable conditions and
providing unimpeded coverage for FDA approved Makena.
"This is an important day for pregnant women who can benefit
from Makena," said Greg Divis,
President and CEO. "Healthcare providers have advocated for
unencumbered access to FDA-approved Makena. We believe the
announcements from these two key agencies are a clear signal that
the compounding of hydroxyprogesterone caproate should not exceed
the scope of traditional pharmacy compounding and that payers who
have made access to Makena difficult should remove roadblocks that
have prevented patients from receiving the only FDA-approved drug
for their condition."
As part of its commitment to patients and healthcare providers,
the Company has made substantial efforts to work with payers to
facilitate insurance coverage of Makena®. The Company's
significantly reduced pricing to both commercial and Medicaid
payers make the cost of a full course of therapy a small fraction
of the cost of the average preterm birth. Further, patient
co-pays are averaging approximately $8 per injection (often less than the cost to
patients for compounded 17P formulations). The Company
provides Makena at no out-of-pocket cost to uninsured women through
its financial assistance programs.
The Company has entered into agreements with a number of States
that provide unencumbered access to Makena for eligible
patients. With the support of the June
15th statement by CMS, the Company looks forward to working
with all payers to help ensure patient access to Makena, especially
Medicaid payers, because low-income pregnant women are known to be
at higher risk for premature birth.
"As a high-risk pregnancy specialist caring for women who are at
risk of preterm birth, I need to be able to prescribe medications
that have been tested and proven effective," said Sean C. Blackwell, MD, Interim Chair, Department
of Obstetrics, Gynecology and Reproductive Sciences at the
University of Texas Health Science Center in
Houston, Texas. "Pregnant women deserve to have access
to FDA-approved medications. I am hopeful that the policy
modification from CMS will help to remove obstacles that have
prevented some Medicaid participants from getting the same 17P
formulation that was utilized in the NICHD Maternal Fetal Medicine
Units Network clinical trial and was compliant with Good
Manufacturing Practices."
The full FDA and CMS updates can be found here.
FDA Update
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm
CMS Update
http://www.medicaid.gov/Federal-Policy-Guidance/Downloads/CIB-2-06-15-12.pdf
New Global Report Says U.S. Lags Behind 130 other Nations in
Preterm Birth Rate
The report, containing the first-ever estimates of preterm birth
rates by country, was published in May
2012 by The March of Dimes Foundation, The Partnership for
Maternal, Newborn & Child Health, Save the Children, and The
World Health Organization, and represents almost 50 United Nations
agencies, universities, and organizations.
Preterm babies are born at a higher rate in the United States than in 130 other countries
of the world, including many poorer nations, according to the
just-released report Born Too Soon: The Global Action
Report on Preterm Birth. The report ranks the U.S.
131st in the world in terms of its preterm birth rate of
12.0 per 100 live births. Nearly half a million babies are
born too soon in the U.S. each year.
About Makena® (hydroxyprogesterone caproate
injection)
Makena is a progestin indicated to reduce the risk of preterm
birth in women with a singleton pregnancy who have a history of
singleton spontaneous preterm birth. The effectiveness of Makena is
based on improvement in the proportion of women who delivered