Following Call From Brown and 14 Senators, FDA Announces Action To Address Critical Drug Shortage

With Shortages of Products Critical to Infant Nutrition, Brown and 14 Other Senators pushed the Food and Drug Administration to do all in its Power to Ensure Providers and Patients have Access to Them

WASHINGTON, D.C. – Today, U.S. Senator Sherrod Brown (D-OH) applauded an announcement by the Food and Drug Administration (FDA) that it will address a severe shortage of injectable drugs – used to treat the nutrition of critically ill infants among other populations – by allowing the safe importation of these drugs from abroad. The announcement comes on the heels of a letter signed by Brown and 14 of his Senate colleagues urging the FDA to do everything in its power to get these products back on the market. This injectable drug shortage, and subsequent action taken by the FDA, affects infants in hospitals across the state, including Summit County’s Akron Children’s Hospital. Prior to FDA action, institutions like Akron Children’s had serious fears that the shortage could affect their treatment of critically ill babies.

“Any drug shortage is of concern, but shortages of drugs that provide critical nutrition assistance to premature and critically ill infants are particularly alarming,” Brown said. “I applaud the FDA’s prompt response to the shortage and the steps it has taken to put these products back in the hands of children’s hospitals across Ohio.”  

In a bipartisan letter to the FDA on May 6, Brown and 14 of his Senate colleagues raised alarms over shortages of sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride, zinc, among others and the effect of these shortages on the nutrition treatment for infants. Brown’s letter to the FDA can be read in its entirety HERE:

While hospitals can take measures in the short-term, long-term drug shortages can affect patient care. Akron Children’s Hospital, for instance, adopted strict drug conservation and rationing methods designed to make its limited supply last as long as possible. Shortages of trace elements and calcium gluconate reached critical levels, to the point that the institution was concerned that it would no longer be able to prepare these much-needed nutrition products for babies who needed them most. The hospital found that it was down to a two-week supply of calcium gluconate and ran out of the injectable trace element selenium. 

Brown has long fought to prevent drug shortages and to protect the health and wellbeing of Ohioans. In June 2012, Congress passed Brown’s provision that allows hospital systems to tackle drug shortages, treat more patients, and save more lives. Brown’s provision, which was conceived at a roundtable Brown held at OSU in January 2012, is aimed at addressing shortages of critical cancer drugs and other lifesaving medications. It was included in a larger bill passed by Congress, the Prescription Drug User Fee Act (PDUFA). The PDUFA legislation also includes major provisions from a second Brown-sponsored bill, the Preserving Access to Life-Saving Medications Act. This bill triggers alerts to FDA of manufacturing incidents that could result in a drug shortage, and requires the FDA to provide updates to the public about potential shortages—allowing doctors, pharmacists, and patients to work together to avoid an interruption in care.

In February, Brown introduced the National Pediatric Research Network Act, bipartisan legislation that would designate more funding for pediatric medical research. The bill would ensure a better-coordinated National Institutes of Health (NIH) pediatric research investment that will produce a greater return on our investment and help the children of today—and tomorrow— overcome numerous devastating diseases and conditions. The bill seeks a reasonable proportion of pediatric research grants for rare diseases or conditions.

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