WASHINGTON (Reuters) - Breast milk banks should remain largely unregulated for now, U.S. health advisers said on Monday, wary of raising further obstacles to obtaining donor milk until further study is done.
High costs, skepticism among doctors and other issues already prevent more babies from receiving human milk when their mothers have trouble breast-feeding, a Food and Drug Administration panel of outside experts was told.
There is agreement that a mother’s milk is the best choice to feed infants, but premature birth, illness or even maternal death can make breast-feeding impossible.
The FDA has become concerned that the possible risks of some donated breast milk could outweigh the benefits. It warned parents in a notice last week not to casually use breast milk from unscreened mothers because of the risk of disease or contamination from bacteria, drugs or chemicals.
The agency is weighing whether to step in and regulate such banks, just as it does the $4 billion infant formula industry.
Overall, donor banks seem to be regulating themselves well, panelist and University of Wisconsin pediatrician Dr. Frank Greer told the FDA, saying “we have a good system.”
The milk banks are largely nonprofit, although at least one company, privately held Prolacta Bioscience which partners with Abbott Laboratories, sells human milk-based products for infants.
Pauline Sakamoto, past president of the Human Milk Banking Association of North America, which runs 10 nonprofit banks, said her group needs 8 million ounces a year just for premature babies, but processed 1.5 million ounces last year.
Screening, transportation and other expenses means donated milk costs far more than formula, at $3 to $5 an ounce. Doctors must prescribe the milk and few insurers cover it.
Some presenters worried a greater government role could make it even 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.
FDA Deputy Commissioner Dr. Josh Sharfstein told the advisers that the agency backs breast-feeding, but is deciding whether to get involved in regulating donated milk.
“FDA doesn’t have plans at this time to enhance its role in donated breast milk,” said Sharfstein, a pediatrician. But involvement “in a reasonable way” is possible, he added.
The International Formula Council, which represents formula makers such as Abbott, Mead Johnson Nutrition Co and Nestle AG, supports the FDA’s look at milk banking.
Some panelists agreed. “This same process should be applied to human milk,” said Dr. Jatinder Bhatia of Medical College of Georgia.
But another panelist, Dr. Henry Farrar of Arkansas Children’s Hospital, cautioned too many rules could quickly shut down human milk banks altogether.
“If we over regulate ... we kind of kill the whole thing right there,” he said.
Panelists did agree more research was needed.
Reporting by Susan Heavey; Editing by Andre Grenon and Tim Dobbyn
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