Navigation Links
Society for Maternal-Fetal Medicine commends FDA on makena announcement
Date:3/30/2011

WASHINGTON, D.C., March 30, 2011 The Society for Maternal-Fetal Medicine (SMFM) weighed in on today's FDA announcement to continue to allow pharmacies to compound hydroxyprogesterone caproate, also known as 17P. This FDA announcement comes in response to an outcry from SMFM, ACOG and others regarding the costs of the just-released pharmaceutical version of the drug. The new drug, Makena, made by KV Pharmaceuticals, is being sold at $1,500 per dose as opposed to the pharmacy compound which typically costs $10 to $20 per dose.

"The Society for Maternal-Fetal Medicine commends the FDA on its recently released position that it will exercise enforcement discretion with respect to compounding hydroxyprogesterone caproate," stated George Saade, president of SMFM. "This action will ensure that this life-saving treatment will continue to be available for all those who need it. Affordable access to hydroxyprogesterone caproate is critical in ensuring the health and full-term birth of babies in the U.S."

Typically, once a drug is approved by the FDA, pharmacy compounding is no longer allowed. The FDA stated that KV Pharmaceuticals had sent "letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena." The FDA statement goes on to state that "This is not correct."

The research for Makena was funded by taxpayer dollars which funded the initial clinical trial in 2003 under the auspices of the National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health. Additional trials were funded by NICHD through its multicenter network of medical institutions over several years. The studies found that pregnant women who had previously delivered a preterm baby, if treated with weekly injections of hydroxyprogesterone caproate, had fewer preterm babies, and the babies had fewer complications of prematurity. The drug was also found to be effective in both African American and Non-African American women. An economic analysis authored by Dr. Balit of Case Western Reserve University showed that weekly injections of compounds similar to Makena, given to at risk women, would dramatically reduce the incidence of premature birthsand more over it could save the health care system at least $2 billion per year.

"When you consider that the ideal treatment for these at-risk women is administered during weeks 16-36 of pregnancy, under KV Pharmaceuticals dramatic increase the total cost for treatment per pregnancy could soar as high as $30,000," Saade further explained. "This financial barrier could discourage and lockout at-risk women, especially low income women, from receiving this life-saving injection. The FDA announcement will allow all women to continue to receive affordable treatment."


'/>"/>

Contact: Vicki Bendure
vicki@bendurepr.com
202-374-9259
Society for Maternal-Fetal Medicine
Source:Eurekalert

Related medicine news :

1. Use of $4 generic drug programs could save society billions of dollars, study shows
2. Cancer surgery society presents top honor to Kimberly Duchossois
3. American Society for Microbiology to host 111th General Meeting in New Orleans
4. Latest American Chemical Society podcast: Dont blame the pill for estrogen in drinking water
5. Research uncovers a secret society connecting through the Internet
6. American Cancer Society honored for work in palliative care
7. American Chemical Society unveils International Year of Chemistry virtual journal
8. American Physical Society announces Physical Review X
9. New Society for Social Neuroscience to help guide emerging field
10. Onconova to present clinical trials update on ON 01910.Na at American Society of Hematology Meeting
11. New American Chemical Society podcast: Black rice bran may reduce inflammation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2017)... ... 24, 2017 , ... Myers Jackson is well known for auctioning homes that ... homes anywhere on the planet. The luxury home market is alive and well and ... A quick search of “11 Spyglass Hill Auction will enlighten you on the dynamics ...
(Date:5/24/2017)... ... May 24, 2017 , ... Medic CE , a Career Step company, ... Septic Shock” hosted by the Journal of Emergency Medical Services (JEMS). The free webinar, ... be presented by Captain Rommie Duckworth, LP, a career fire captain as well as ...
(Date:5/24/2017)... ... May 24, 2017 , ... Adelberg-Montalvan ... dentistry options for its patients on Long Island, New York. , Holistic ... being, and is one of the biggest trends in dentistry today. , ...
(Date:5/24/2017)... ... 24, 2017 , ... Fiberstar, Inc., http://www.FiberstarIngredients.com a ... beverage industry offers Citri-Fi®, a natural citrus fiber, to improve beverage ingredient declarations. ... a result, labels need to deliver simple, transparent and clear messaging. Listed food ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... Clinical Integration company, announced today that its iClinic V12.2 solution has achieved approval ... NCQA recently introduced PCMH 2017 standards which emphasize team-based care with a ...
Breaking Medicine News(10 mins):
(Date:5/10/2017)... , May 10, 2017 Global Health Intelligence ... Latin America , published its 2017 ranking of ... is based on extensive data analysis from GHI,s hospitals ... hospitals database for the region. The GHI database covers 86% ... offering more than 130 data points for each institution in ...
(Date:5/9/2017)... 2017 Zimmer Biomet Holdings, Inc. (NYSE and ... announced it has earned a spot on Forbes, ... Company was ranked among 500 U.S. employers as well ... Equipment and Services. The annual Forbes ... independent survey of over 30,000 employees across 25 industries. ...
(Date:5/8/2017)... , May 8, 2017 MACRA replaces ... from fee for service reimbursement. Black Book Research crowdsource-surveyed ... 1.       The Market for MIPS Compliance Technology ... of physician practices with 3 or more clinicians seek ... by Q4. "Given the magnitude of the changes, the ...
Breaking Medicine Technology: