2010-04-02 / Top Stories

Meeks Helps Family Gain FDA Approval

Congressman Gregory W. Meeks has announced that the United States Food and Drug Administration (USFDA) will allow Sandra and Juan Gomez, a family residing in the 6th Congressional District, to obtain a baby formula from Europe that may help save the life of their son, Jayden. The two-year-old has been diagnosed with a rare metabolic disorder, nonketotic hyperglycinemia (NKH), which results in seizures. XGLY Analog, a baby formula manufactured and used in a number of European countries, could help.

At a press conference in his 6th Congressional District office, Congressman Meeks said, “Jayden’s doctors determined that this formula, which is not available in the United States, could provide the necessary supplementary nutrients so that Jayden can gain weight and develop both physically and neurologically. I was able to take this up with Health and Human Services and the United States Food and Drug Administration (USFDA). And after a number of consultations, it gives me great pleasure to announce that under its compassionate use guidelines, the FDA will allow the importation of this infant formula specifically for Jayden Gomez.” Compassionate use is granted by the USFDA for a serious condition if appropriate formulas are not available from infant formula manufacturers in the United States.

Although there are formulas available in the United States that can be used to treat a variety of metabolic disorders related to problems breaking down amino acids, Jayden’s team of doctors found that all of those used in treating NKH also contain glycine. Jayden was diagnosed with NKH when he was just two weeks old. He has not gained weight in several months, and was hospitalized in January with diarrhea and dehydration. Melanie Walsh, a metabolic dietitian at the Steven and Alexandra Cohen Children’s Hospital, said, “Jayden’s condition limited his consumption of regular foods containing amino acids; given his limited intake, and without the formula it could be difficult for him to gain weight.”

“Juan and I tried so hard, we were desperate to find a solution because we did not want to give up on our son. Thank you Congressman Meeks.” Sandra continued, “I would like to make a promise to you, Congressman Meeks, that we will return with Jayden when he gets older to show you how much he has grown.”

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