Senator Tom Harkin (IA) and Representative Fred Upton (MI): Compel FDA to End IV Drug Shortages Now
  • Petitioning President of the United States

This petition will be delivered to:

President of the United States
U.S. Senate
U.S. House of Representatives
Iowa
Sen. Tom Harkin
Michigan-06
Rep. Fred Upton

Senator Tom Harkin (IA) and Representative Fred Upton (MI): Compel FDA to End IV Drug Shortages Now

    1. Ann Weaver
    2. Petition by

      Ann Weaver

      Naperville, IL

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.

Recent signatures

    News

    1. Shortages of .9% Normal Saline Reported

      Ann Weaver
      Petition Organizer

      FDA announced it is aware of the shortage intravenous (IV) solutions, particularly 1 liter bags of 0.9% Normal Saline. They stated that they are working with the three manufacturers to help preserve the supply of these necessary products.

    2. Reached 3,000 signatures
    3. Michigan residents still feeling facing shortages of critical IV drugs

      Ann Weaver
      Petition Organizer

      A reccent NPR news story puts a face to the challenges of IV drugs shortages.
      rhttp://stateofopportunity.michiganradio.org/post/drug-shortages-are-affecting-children-nicu
      .

    4. IV Drug Shortages continue

      Ann Weaver
      Petition Organizer

      Despite the FDA's temporary allowance of importation of IV phosporus and trace elements-shortages exist in both the hospital and home setting. News reports from across the country share the growing concern within the medical community. We need continued support to raise awareness and to put an end to IV drug shortages that pose a risk to all Americans.

      http://www.post-gazette.com/stories/news/health/pittsburghs-neonatal-intensive-care-units-struggle-with-nutrient-shortages-690977/

      http://www.onclive.com/conference-coverage/asco-2013/Most-Oncologists-Say-Drug-Shortages-Are-Affecting-Treatment-Decisions-Three-Surveys-Find

      http://www.wggb.com/2013/05/29/drug-shortage-continues-for-hospitals-nationwide/

      http://www.oley.org/documents/Drug_Shortages_Hit_Home.pdf

      modern medicine : hungry for a solution.

    5. Reached 2,500 signatures
    6. FDA allows temporary importation of injectable nutrition drugs

      Ann Weaver
      Petition Organizer

      In a press release today the FDA announced it would be "exercising regulatory discretion for Fresenius Kabi USA, LLC, based in Lake Zurich, Ill., to import trace elements and phosphate injection from its Norway plant so the drugs can reach Americans in need."

      http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354272.htm

      While this is a step forward to end several critical shortages, no mention was made of other IV nutritionals still on the shortages list, including IV multi-vitamins and lipids.

      While this temporary move will bring immediate relief to both consumers and clinicians, it is still a short term fix for a long term need.
      We need to continue to join together to with a unified voice to bring an end to IV drug shortages.

    7. Reached 1,500 signatures

    Supporters

    Reasons for signing

    • Juliet Martinez FORT WORTH, TX
      • 24 days ago

      My daughter is currently tpn dependent due being born with an Omphalocele and the complications that come with it. Her life and well being depend on iv drungs known as tpn and lipids.

      REPORT THIS COMMENT:
    • Sally Tice ASHLAND, PA
      • 4 months ago

      I work in the health care profession making TPNs and it is very difficult and really affects the patients first hand

      REPORT THIS COMMENT:
    • Sarah Tudor CINCINNATI, OH
      • 5 months ago

      People have died and will continue to die. There is NO excuse for this.

      REPORT THIS COMMENT:
    • Laura Lipari MASSAPEQUA, NY
      • 5 months ago

      I'm a dietetic intern

      REPORT THIS COMMENT:
    • Lynda Newman CLEVELAND, OH
      • 5 months ago

      I am a Nurse Practitioner working with patients on Home Parenteral Nutrition. The shortages seriously impact our ability to care for our patients safely (besides being an embarrassment in a 1st world country).

      REPORT THIS COMMENT:

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