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:10/13/2017)... N.Y (PRWEB) , ... October 13, 2017 , ... Lori ... became a member of ElderCounsel, a national organization of elder law and special needs ... changing laws and rules. It also provides a forum to network with elder law ...
(Date:10/13/2017)... ... , ... Many families have long-term insurance that covers care for a family ... for care if the client has a cognitive impairment diagnosis. , “What this ... often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, owner ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at ... of the most popular and least understood books in the Holy Scriptures, Revelation. The ... that have baffled scholars for centuries. Many have tossed it off as mere rubbish, ...
(Date:10/13/2017)... Fairfax, VA (PRWEB) , ... October 13, 2017 ... ... provider of DevOps and Agile Software Development, has been awarded a contract by ... (EATS) Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... DIEGO , Oct. 12, 2017 AVACEN ... recognized the company with their  2017 New Product Innovation Award ... based on extensive primary and secondary medical device market research ... Medical, through its first-to-market OTC, drug-free pain relief product, the ... unique approach to treating fibromyalgia widespread pain. ...
(Date:10/11/2017)... , Oct. 11, 2017  Caris Life Sciences ... on fulfilling the promise of precision medicine, today announced ... joined Caris, Precision Oncology Alliance™ (POA) as its 17 ... centers, the St. Jude Crosson Cancer Institute will help ... the use of tumor profiling, making cancer treatment more ...
(Date:10/10/2017)... 10, 2017   West Pharmaceutical Services, Inc. ... injectable drug administration, today shared the results of a ... improving the intradermal administration of polio vaccines. The study ... in May 2017 by Dr. Ondrej Mach , ... Health Organization (WHO), and recently published in the journal ...
Breaking Medicine Technology: