NCfIH Expresses Opposition to California Senate Bill 1316

March 30, 2016

Senator Lois Wolk
Senate Health Committee
State Capitol, Room 5114
Sacramento, CA 95814

RE: Senate Bill 1316

Dear Senator Wolk and Members of Senate Health Committee,

I am writing on behalf of the membership of the National Coalition for Infant Health (NCfIH) to express opposition to the above referenced bill. NCfIH is a collaborative of professional, clinical, community health, and family support organizations focused on improving the lives of at-risk infants including premature babies and their families. NCfIH is affiliated with the Alliance of Patient Access (AfPA), which routinely makes comments on policy matters impacting patient access to approved therapies and appropriate clinical care.

California SB 1316 presents a concerning access issue for premature babies. Its adoption could have the unintended consequence of reducing the supply of human breast milk donations and the production of a critical breastmilk supplement for premature babies. As it currently it currently drafted, SB 1316 would prevent human donor milk banks that financially compensate their donors from approaching mothers about the possibility of donation until they are six months post-delivery. The criteria for donation in SB 1316, including the six-month post delivery mandate, is not evidence based. The American Academy of Pediatrics recommends an exclusive human breast milk diet for all babies until six months. Some breastfeeding mothers, like those with twins, have the capacity to increase supply in response to demand. The breastmilk quality is uniform.

The use of human donor milk is essential for the prevention of serious morbidities in premature infants, and no premature baby should be denied the benefit of an exclusive human milk diet. Premature babies require additional calories for growth, but at the same time there is a limit to the volume of breastmilk they can be given. The traditional response to this need has been to provide supplementation in the form of added carbohydrate, protein, and fat from a non-human derived source. Providing the necessary nutritional benefit came at a risk. Increased exposure to non-human protein as well as increased thickening of the resultant formula created increased risk for feeding intolerance, infection of the intestines (necrotizing enterocolitis), and death.

The nutritional benefit provided by human milk based supplements does not carry the same risk. Numerous studies have confirmed increased feeding tolerance, better weight gain velocity, and most importantly decreased necrotizing enterocolitis in premature babies who are at most risk.

Although non-profit milk banks are important in providing donor milk, it is only for-profit companies that manufacture the human milk based supplements that help premature babies grow without the attendant risk that non-human milk based fortifiers pose for premature infants.

By inhibiting donations to the manufacturers of this important mill supplement, SB 1316 decreases the efficacy of the human milk provided by all milk banks by threatening to shift supplementation back to non-human human milk fortifier.

This bill was not requested by pediatricians or neonatologists, and NCfIH urges the committee to consult with these specialized healthcare providers before acting. The impact of unintended consequences from an uninformed approach could have dramatic consequences for the most fragile of patients.

Safety is another consideration. Although breastmilk is not regulated by the FDA in the same way as a biologic or pharmaceutical product, there are inherent risks in using any human-based product if appropriate screening procedures are not followed. Those additional safety measures that for-profit companies have adopted are above and beyond other regulatory guidance. Their vigilance in bringing blood and plasma level quality control to the breastmilk industry has been praised by the FDA.

Finally, the distinction of profit versus non-profit does not mean “no cost.” Non-profit and for-profit suppliers both sell the milk that they produce to hospitals across the nation.  Both are important and valuable sources that ensure access to a vital nutrition for the at-risk patient population.

This bill may have been designed to rein in irresponsible business practices by commercial human milk banks, but it instead creates barriers to an exclusive human milk diet for the premature infants who need it most.


Mitchell Goldstein, MD
Medical Director
National Coalition for Infant Health