Washington, DC – U.S. Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) today called on drug manufacturers to boost production to end the current shortage of critical drugs used to treat infants in intensive care. In a letter to top drug manufacturers, the senators urged the companies to take all necessary steps to rapidly increase production and help alleviate the shortage. Last year, provisions introduced by Klobuchar and Casey to prevent and improve responses to drug shortages were passed into law as part of the Food and Drug Administration Safety and Innovation Act.
“The last thing a parent with a sick child should have to worry about is where their next treatment is going to come from,”Klobuchar said. “Manufacturers need to do everything in their power to boost production to make sure these children can get the medication they need and deserve.”
“It is imperative that we take every step possible to provide these infants with the care they deserve,”said Senator Casey. “Manufacturers should do everything they can to boost production and alleviate these troubling drug shortages.”
Klobuchar has long fought to prevent drug shortages to help protect patients and save lives. The Food and Drug Administration Safety and Innovation Act, signed into law last year, includes a bipartisan drug shortages agreement that Klobuchar helped forge that will require prescription drug manufacturers to give early notification to the Food and Drug Administration (FDA) of any incident that would likely result in a drug shortage. The bill also contained Klobuchar’s provisions directing the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage, and require the FDA to keep detailed records of previous drug shortages and the actions taken to prevent them.
The full text of the letter is below.
May 3, 2013
Mary Jane Helenek F. Michael Ball John Ducker
President and CEO CEO President and CEO
Luitpold Pharmaceuticals, Inc. Hospira, Inc. APP Pharmaceuticals
One Luitpold Drive 275 N Field Drive Three Corporate Drive
Shirley, New York 11967 Lake Forest, IL 60045 Lake Zurich, IL 60047
Dear Ms. Helenek, Mr. Ball, and Mr. Ducker,
We write to you today because you manufacture several drugs currently in shortage that are critical to the care of infants, and we ask that you cooperate closely with the Food and Drug Administration (FDA) to resolve these shortages as soon as possible.
Ensuring access to necessary and lifesaving medicines and vaccines is critical to the health and well-being of our nation’s patients. In recent years, drug shortages have become an increasingly troubling problem in the United States hitting record numbers in 2011. Although the total number of new drug shortages has declined, we are still facing shortages of over 200 drugs, including drugs used to treat cancer, reduce pain, and provide nutrition to premature and critically ill infants.
The shortage of parenteral nutrition for infants is particularly critical. Calcium gluconate, sodium phosphate, potassium phosphate, potassium acetate, sodium acetate, pediatric trace elements, adult trace elements, and zinc are used to treat critically ill infants and are currently in shortage. We are deeply concerned about the impact the shortage of these products is having on the children who depend on them.
Minimizing the impact of a drug shortage requires the cooperation of regulatory agencies, providers, manufacturers, and policy makers. We urge you to work closely with the Food and Drug Administration and focus your resources to speed or restart production of drugs that are in shortage. In addition, we urge you to provide to the affected parties an immediate and clear timeline about the impact your actions will have on the availability of these products so all necessary actions may be taken to protect patients.