Senator Tom Harkin (IA) and Representative Fred Upton (MI): Compel FDA to End IV Drug Shortages Now
Tell Senator Tom Harkin (D-IA) , Representative Fred Upton (R-MI) and President Obama, that the FDA MUST ensure that all U.S. citizens have reliable and continuous access to IV drugs and medications.
Lives have been lost, and the lives of many others, from infants to seniors, are being put at risk due to the critical and chronic IV drug shortages.
A recent Washingtonian article, http://www.washingtonian.com/articles/people/children-are-dying/ chronicles the challenges faced by families and individuals who depend on IV therapies to live and thrive. The article also explains the growing concern within the medical community about these shortages which are typically seen in only 3rd world countries.
If the current drug shortages are not resolved and plans are not enacted to prevent future shortages every citizen of the United States who requires IV fluids, nutrition and therapy now or in the future are at risk.
Help us tell Senator Tom Harkin (D-IA) and the Representative Upton (R-MI), the Chairs of the Congressional committees that oversee the FDA that they should do all they can to compel the FDA to immediately work together with the drug manufacturers to protect the lives of all Americans by:
1. Immediately resolving current IV drug shortages, by incentive, import, and expediting drug approvals..
2. Developing clear plans to prevent future IV drug shortages by the end of 2013.
Protecting the lives of infants, children and seniors from a clear threat is not a partisan issue. Solutions are clear and Congress should do all it can before another child dies.
History: Let us introduce you to two of the more than 450,000 U.S. Citizens that require these IV nutrition support each year. Separated by miles and years Paige and Tim are just two Americans whose lives and health are in jeopardy because of the current drug shortages.
Paige, a three year old little girl, became dependent on IV nutrition within hours of her birth. She had to have almost her entire small bowel surgically removed leaving her with what is known as short bowel syndrome. Drug shortages have greatly affected Paige. She is not receiving phosphorus, calcium, zinc or multi vitamins that are essential for her to live, grow and develop. Also, she is not receiving alteplase, drug used in her permanent intravenous line in case of clotting. Without a fully functioning bowel, Paige faces certain death without IV nutrition support.
Meet Tim, sophomore in college and co-founder of a non- profit supporting camps for kids with chronic illness. Tim, like Paige was also diagnosed with short bowel syndrome and first required IV nutrition while in the NICU at birth. Without IV nutrition he would not have survived his first month of life or the following seven years when he depended on IV support at home. Since going back on TPN 3 years ago, he has experienced shortages of calcium, phosphorus, multi-vitamins, zinc, selenium, chromium and lipid(fat). These shortages compromise his immune system and put him at increased risk of contracting lethal blood infections. They also effect his bone health and overall health.
- U.S. House of Representatives
Dear Senator Harkin, Representative Upton and President Obama:
We write to you in your official capacity as President and the Chairmen of the respective Senate and House committees with oversight of the Food and Drug Administration (FDA) to request your assistance in resolving the serious drug shortages that continue to plague the nation. These critical drugs, including sterile components of intravenous nutrition, provide vital therapies to thousands of individuals across the country every day. Without these medications our lives, and those of our children and loved ones are at immediate risk.
As you know, the FDA Safety and Innovation Act (FDASIA) was signed into law July 2012 providing the FDA with new ways address drug shortages. However, despite that passage of the FDASIA, the problem continues at an alarming rate with shortages becoming more common each day.
We write to ask that you use your position as the Chairmen of the Senate Health, Education, Labor and Pensions Committee to ensure that the FDA is doing all that it can to work with drug manufacturers to resolve this issue immediately before more patients are put at risk. Specifically, we request that you seek:
1. Immediately, utilize whatever means: incentive, import, and expediting drug approvals resolve current IV drug shortages.
2. Develop clear plans to prevent future IV drug shortages.
Across the country thousands of people from newborn babies to senior citizens rely on IV medications to treat diseases and provide vital nutrients. Their health is dependent on a continued supply of these drugs. Their lives should not be jeopardized by lack of Congressional oversight or ineffective agency action to address this problem.
We thank you for your immediate attention to this critical issue and look forward to your response,
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