FDA takes action to ease neonatal drug shortage

WASHINGTON (AP) — Federal health regulators are allowing overseas imports of critical intravenous drugs used to nourish premature infants, amid a shortage that has affected hospitals nationwide.

The Food and Drug Administration said Wednesday new supplies of drugs used in total parenteral nutrition, a ubiquitous hospital staple, will be available to U.S. patients this week. The injectable formula is used to feed newborn infants, cancer patients and other vulnerable groups who are unable to eat or drink by mouth.

The food solution contains trace drug ingredients, including potassium phosphate, which have been in short supply.

FDA officials said they are temporarily allowing imports of those ingredients from a plant in Norway to ease shortages triggered by the shutdown of American Regent, the primary U.S. manufacturer.

American Regent halted operations late last year to fix contamination issues uncovered by FDA inspectors. Regulators found a number of problems at the company’s Shirley, N.Y., facility, including specks of matter floating in injectable drugs.

FDA officials said the agency has inspected the Norway facility operated by Fresenius Kabi, and confirmed it meets U.S. manufacturing standards.

“We believe the import of these injectable nutrition drugs will meet patient needs over the coming weeks — but initially hospitals should just order what they need at this time.” said Valerie Jensen, associate director of the FDA’s drug shortages program, in an interview with the Associated Press.

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers.

While once considered an extraordinary step, the FDA has been increasingly allowing imports from factories that don’t normally ship to the U.S.

Since 2010, the agency has allowed the importation of 14 drugs to combat U.S. shortages. Wednesday’s action will bring that number to 17, with addition of three new drugs used in nutritional formula.

There are currently 129 drug shortages in the U.S., according to the FDA.

The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories. In addition, consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs, has led to decreased capacity.

Under a law passed last year, all drug manufacturers must notify the FDA of any production changes that could lead to drug shortages. Meanwhile, FDA officials say they are working with manufacturers to fix underlying problems with quality control and contamination that are responsible for the wave of shortages.

“In the near term companies are letting us know about these problems early on, which is good news,” said Jensen. “Over the longer term we’re hoping we’ll have a safer drug supply as these companies upgrade and modernize their facilities.”

Jensen said American Regent is in the process of resuming drug operations, but because of the extended shutdown it will take time to ramp up production to the levels needed. She said the FDA will continue to allow nutritional imports as long as necessary.

 

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