Costs, Rules Hamper Donated Breast Milk

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High costs, skepticism among doctors and other issues are preventing more babies from receiving human milk from special banks when their mothers have trouble breastfeeding, experts said on Monday as federal officials consider whether to step in and regulate.

Although experts agree a mother's milk is the best choice to feed infants, a huge gap exists when premature birth, illness or even maternal death make breastfeeding impossible. Parents must use infant formula or milk banks that screen and distribute donated breast milk.

The Food and Drug Administration is weighing whether to step in and regulate such banks, just as it does the $4 billion infant formula industry. The banks are largely nonprofit, although at least one company sells human milk-based products for infants made from separately collected sites.
Critics worry a greater government role could hamper an already difficult struggle 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.

At a meeting of FDA outside advisers, FDA Deputy Commissioner Dr. Josh Sharfstein said the agency backs breast-feeding, but is deciding whether to get involved.

"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.

U.S. and Canadian health officials issued warnings earlier this month urging against sharing breast milk outside of special banks because of the potential risk of contamination or the spread of viruses such as human immunodeficiency virus that causes AIDS.

The International Formula Council, which represents formula makers with estimated sales of $4 billion, said it supports FDA's look at banking. Makers have faced their own hurdles in recent years, including contamination that forced recalls.

FEAR OF OVER REGULATION

The FDA's panelists were mixed over just how far the agency should reach, with some noting the need to streamline state rules and apply the same oversight now seen for formula makers, which include companies such as Abbott Laboratories, Mead Johnson Nutrition Co and Nestle AG.
"This same process should be applied to human milk," said panelist Dr. Jatinder Bhatia of Medical College of Georgia.

But panelist Dr. Henry Farrar of Arkansas Children's Hospital cautioned too many rules could quickly shut down banks altogether.

"If we over regulate ... we kind of kill the whole thing right there," he said.

Panelists also expressed concern that more companies may get involved in breast milk banking in search of profits. So far, just privately held Prolacta Bioscience, which partners with Abbott, uses certain banks for its breast-milk based feeding products.

Breast-feeding has become a global public health issue as more countries promote breast-feeding to not only provide babies critical nutrition, but also to prevent disease and obesity. The U.S. health reform law passed in March includes measures to encourage breast-feeding and U.S. officials last week renewed efforts to get more women to breast-feed
longer.

U.S. banks are few. Screening, transportation and other expenses mean donated milk costs more than formula, at $3 to $5 an ounce. Doctors must prescribe the milk and few insurers cover it.
Pauline Sakamoto, past president of the Human Milk Banking Association of North America, which runs 10 nonprofit banks, said her group need 8 million ounces a year just for preemies, but processed just 1.5 million ounces last year.

More women who are unable to access banked milk, but want to avoid formula have turned to the Internet to connect and share milk, vowing to continue despite the recent warnings, saying the benefits of breast milk outweigh any possible downside.

There are risks, National Women's Health Network Policy Director Amy Allina told Reuters. But "until the public policy catches up with the need so screened breast milk is available to all babies who need it, we're not against women sharing breast milk."