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Avion Pharmaceuticals, LLC, Responds to First Data Bank Decision: 'Pregnant Women And Expectant Infants Will Be Compromised'

Avion Pharmaceuticals

News provided by

Avion Pharmaceuticals, LLC

May 18, 2017, 11:30 ET

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ATLANTA, May 18, 2017 /PRNewswire/ -- Avion Pharmaceuticals, LLC, the makers of the Prenate® line of prescription prenatal vitamins, has been informed of an announcement from First Data Bank, Inc. First Data Bank is the publisher of pharmaceutical information that is used within healthcare information systems for medication decision support and negotiating reimbursement rates paid to pharmacies and other providers. During National Women's Health Week1, sponsored by the Department of Health and Human Services, First Data Bank is preparing to alter the status of all prescription prenatal vitamins from a categorization of prescription to a categorization of over-the-counter status which will negatively affect the health and safety of millions of patient lives. Eliminating the ability of prescribers to no longer deliver the gold standard of prenatal nutritional support with prescription prenatal vitamins will directly impact their prenatal patients and put women preparing for pregnancy or newly pregnant at great risk for negative pregnancy outcomes such as neural tube defects such as spina bifida and anencephaly. 

In the United States approximately four million babies are born annually.2  Studies indicated that 50 percent of pregnancies in the U.S. are unplanned and only 11 percent of women aged 18-45 are aware folic acid supplementation should be taken before trying to get pregnant.3-4  With minimal awareness of the importance of folic acid in the prevention of Neural Tube Defects (NTDs) and the rate of unplanned pregnancies it is critical for prescribers and payors to ensure all patients have access to prescription prenatal nutritional support to help remove any risk of negative health outcomes.  Prescription prenatal vitamins are formulated with 1 mg of folate (folic acid) which helps ensure the full protective support for all women regardless of their health and genetic predisposition. Over-the-counter prenatal vitamins have varying levels of folate which may create confusion and abandonment in terms of purchase decisions. Without the protection of adequate levels of the critical nutrient of folate through the care off the prescribing health care provider, unborn babies will be put at risk for serious health outcomes unnecessarily.

"Avion's mission to support the health and well-being of moms and babies is our utmost focus.  By restricting the ability of prescribers to properly manage the prenatal nutritional care of their patients and leaving this in the hands of patient decision-making creates a potential pandemic related to increased birth defects" said Mike Sullivan, President.  "Every pregnancy is unique and requires specific nutritional needs based on prescriber evaluation and expert knowledge.  It is critical to maintain the highest standard of care for the miracle of life including access to prescription prenatal vitamins."

About Avion Pharmaceuticals, LLC

Avion Pharmaceuticals, LLC is a specialty pharmaceutical company formed to develop and market a portfolio of innovative pharmaceutical products in the Women's Heath therapeutic category.  Avion Pharmaceuticals focuses on identifying opportunities to acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage development drugs to fulfill unmet medical needs.  For additional information about Avion Pharmaceuticals please contact the company at 678-325-5188.  For more information, visit www.prenate.com.

1. https://www.womenshealth.gov/nwhw2. https://www.nichd.nih.gov/health/topics/infantcare/conditioninfo/Pages/born.aspx. Reviewed May 15, 2017. Accessed May 1, 2016.3. Guttmacher Institute. Fact Sheet: Unintended pregnancy in the United States. http://www.guttmacher.org/pubs/FB-Unintended-Pregnancy-US.pdf. Published December 2013. Accessed January 14, 2014. 4. March of Dimes Foundation. Improving preconception health: Women's knowledge and use of folic acid. http://www.marchofdimes.com/peristats/pdfdocs/2008FolicAcidSurveyReport.pdf. Published December 2008. Accessed September 13, 2013.

SOURCE Avion Pharmaceuticals, LLC

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