FDA Takes Action To Ease Neonatal Drug Shortage

12:08 PM, May 29, 2013   |    comments
  • Share
  • Print
  • - A A A +

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 Fresenius Kabi 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.

"Since the onset of these shortages, the FDA has been very concerned about the dwindling supply of injectable nutrition products and the effect this is having on children's hospitals treating vulnerable patients," said Valerie Jensen, associate director of the FDA's drug shortages program, in a statement. "We believe the import of these injectable nutrition drugs is going to meet current supply needs over the coming weeks."

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.