Despite Warning, FDA Holding Off on Regulating Donated Breast Milk Banks

Despite issuing a recent warning about the risks of donated breast milk, the Food and Drug Administration has no plans to start regulating breast milk banks around the country.

Dr. Josh Sharfstein, FDA deputy commissioner, told a panel of experts who met Monday to advise the agency on the issue that FDA involvement “in a reasonable way” is possible, but that it has no current plans to step in to oversee the field, Reuters reports.

That stance was in line with advice from some of the expert panelists. They were brought together for the first time by the FDA to review formal human milk banking, a practice dating to 1943 to serve newborns in hospitals, according to the Philadelphia Inquirer.

Some of the experts expressed concern that a greater government role could make it more difficult to get breast milk to the growing number of premature infants and other babies who need it. “We are trying to get more human milk into babies, not less,” said Susan Landers, who oversees lactation services for the Seton Family of Hospitals in central Texas.

Another one of the panelists, University of Wisconsin pediatrician Frank Greer, said  most donor banks are doing a good job of regulating themselves. “We have a good system,” he said.

The FDA warned parents last week about the risk of disease, including HIV, as well as contamination from bacteria, drugs or chemicals in breast milk from unscreened donors. The growing trend of  “casual milk sharing” through online connections and social networking is of increasing concern.

Although breast milk is still considered the best option for infants, such issues as premature birth and illness can make breast-feeding impossible for some. Donated breast milk is expensive, and faces challenges such as skepticism among doctors that prevent many babies from receiving human milk when their mothers have trouble breast-feeding.

Donor banks are mostly non-profit, with the notable exception of Prolacta Bioscience, which partners with Abbott Laboratories.

Donated milk costs far more than formula, at $3 to $5 an ounce, due to screening, transportation and other costs. Doctors must prescribe the milk and few insurers cover it.

The International Formula Council, which represents formula makers such as Abbott, Mead Johnson Nutrition Co. and Nestle AG, has urged the FDA to look into milk banking. The FDA already regulates the $4 billion infant formula industry.

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