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waived in these circumstances to further increase incentives for potential competitors. Entry into the market of more generics manufacturers should increase competition and reduce prices. Of course, other players along the drug-distribution chain, such as wholesalers or pharmacies, may also contribute to price markups, and further investigation is need- ed into the relative contribution of these different actors to the high prices of drugs such as al- bendazole.

Meanwhile, there is little that individual consumers can do. Some drug companies, such as Amedra, offer assistance pro- grams for indigent patients, but these programs often have com- plicated enrollment processes, and they do not offer an effective general safety net.5 Some patients

instead seek to acquire these drugs in other countries, since many of them are widely and in- expensively available outside the United States, but such foreign sources may be of variable qual- ity. Until regulatory and market solutions are implemented to re- duce prices for these older drugs, patients requiring such drugs and the physicians treating them will continue to be faced with difficult choices.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

From the Department of Medicine, Univer- sity of Minnesota, Minneapolis ( J.D.A., W.M.S.); the Department of Medicine, Re- gions Hospital, St. Paul, MN ( J.D.A., W.M.S.); and the Program on Regulation, Therapeutics, and Law, Division of Pharma- coepidemiology and Pharmacoeconomics, Department of Medicine, Brig ham and Women’s Hospital and Harvard Medical School, Boston (A.S.K.).

1. Micromedex 2.0 (electronic version). Greenwood Village, CO: Truven Health Analytics (http://www.micromedexsolutions .com). 2. Colliver V. Prices soar for some generic drugs. SFGate. January 1, 2014 (http://www .sfgate.com/health/article/Prices-soar-for -some-generic-drugs-5105538.php). 3. Government Accountability Office. Brand- name prescription drug pricing: lack of ther- apeutically equivalent drugs and limited competition may contribute to extraordinary price increases. December 2009 (http:// www.gao.gov/new.items/d10201.pdf ). 4. CorePharma and GlaxoSmithKline con- clude agreement on US rights for Dexedrine, Albenza and Daraprim. Press release of GlaxoSmithKline, October 22, 2010 (http:// us.gsk.com/en-us/media/press-releases/ 2010/corepharma-and-glaxosmithkline -conclude-agreement-on-us-rights-for -dexedrineandreg-albenzaandreg-and -daraprimandreg). 5. Choudhry NK, Lee JL, Agnew-Blais J, Corcoran C, Shrank WH. Drug company- sponsored patient assistance programs: a viable safety net? Health Aff (Millwood) 2009;28:827-34.

DOI: 10.1056/NEJMp1408376

High-Cost Generic Drugs

Protecting Progress against Childhood Obesity — The National School Lunch Program Jennifer A. Woo Baidal, M.D., M.P.H., and Elsie M. Taveras, M.D., M.P.H.

Nutrition science has ad-vanced greatly since the in- ception of the National School Lunch Program in 1946. Yet when a 2008 Institute of Medicine (IOM) committee comprising 14 child-nutrition experts examined data on the content of school lunches in the United States, its findings were stark. Children ate strikingly few fruits and vegeta- bles, with little variety. Potatoes accounted for one third of vege- table consumption. Intake of re- fined grains was high. Almost 80% of children consumed more saturated fat than was recom- mended, and sodium intake was

excessive in all age groups. Chil- dren ate more than 500 excess calories from solid fats and add- ed sugars per day.1

In response to these findings, Congress enacted the Healthy, Hunger-Free Kids Act of 2010 (HHFKA), which called for a revi- sion of school-nutrition standards. The updated standards aligned school meals with the 2010 Dietary Guidelines for Americans by in- creasing quantities of fruits, veg- etables, and whole grains; estab- lishing calorie ranges; and limiting trans fats and sodium (see dia- gram). The HHFKA also provided an incentive for schools to adhere

to the regulations: a much-needed increase in meal reimbursement. Implementation of the new stan- dards has been proceeding grad- ually since 2012, and we have an unprecedented opportunity to im- prove the quality of meals con- sumed by U.S. children. Children consume almost half of their to- tal calories at school, and the National School Lunch Program provides low-cost or free lunch to more than 31 million students at 92% of U.S. public and private schools.

But now, just 2 years after its implementation began, the HHFKA is at risk of being under-

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Protecting Progress against Childhood Obesity

mined in substantial ways. Some school officials, food-industry ad- vocates, and the School Nutrition Association (SNA, a professional organization that represents school-lunch programs and whose members include food manufac- turers) have raised concerns about increased food waste, decreased school-lunch participation, diffi- culties in meeting whole-grain and sodium goals, and potential for increased operating costs. In response, the House of Represen- tatives included waivers for school- lunch nutrition standards in its fiscal-year 2015 Agriculture Ap- propriations Bill. The provision

would allow schools with a 6-month net loss of revenue to opt out of providing the healthier meals outlined by the HHFKA. A deficit of any amount from any cause could allow schools to re- turn to the same meals that the IOM found in 2008 to be nutri- tionally lacking. The possibility of such waivers remains real: after elections this November, appro- priations bills and reauthoriza- tion of child-nutrition standards will be on the congressional agenda, and waivers will probably be back on the table.

Complaints by school officials and the SNA about increased food

waste lie at the heart of the argu- ment for waivers. School officials and school-lunch programs have an interest in providing meals at the lowest possible cost, and dis- carded meal components are a waste of both food and money. And indeed, fruit and vegetable waste has been a reality of school meals for years. But one study found no increase in food waste in four low-income schools after the new regulations were imple- mented.2 Researchers who fol- lowed nearly 6000 students, in 2011 and 2012, weighed individ- ual food items after each meal they consumed. They found that

A B Current Daily RequirementsPrevious Daily Requirements

Fruits and Vegetables Combined 1/2 to 1 cup

Grains 1 oz

(8–15 oz minimum per wk)

Meat or Meat Alternative 1.5 to 2 oz

(7.5–15 oz minimum per wk)

Meat or Meat Alternative 1 to 2 oz

(10–12 oz maximum per wk)

Milk 1 cup

No specific types required

Fruits 1/2 to 1 cup

Vegetables 3/4 to 1 cup

Specific types required each wk

Whole grains “encouraged”

Grains 1 to 2 oz

(9–12 oz maximum per wk)

Whole-grain–rich by July 2014

No fat or flavor restrictions

Milk 1 cup

Must be fat-free (flavored) or ≤1% fat (unflavored)

Other Requirements Calories

Minimum requirements vary by menu-planning approach and grade grouping:

Kindergarten to grade 3

Kindergarten to grade 6

Grade 4 to grade 12

Grade 7 to grade 12

Sodium

Saturated fat

Trans fat

633 calories

664 calories

785 calories

825 calories

General goal to “reduce” sodium intake but no set targets

No more than 10% of total calories

No limits

Other Requirements Calories

Minimum and maximum requirements vary by grade grouping:

Kindergarten to grade 5

Grade 6 to grade 8

Grade 9 to grade 12

Sodium

Saturated fat

Trans fat

550 to 650 calories

600 to 700 calories

750 to 850 calories

Three-stage targets by grade level cut sodium intake to ≤740 mg by school yr 2022–2023

No more than 10% of total calories

Zero grams per serving

Previous and Current Federal Requirements for Meal Components and Nutrients in School Lunches.

Beginning in the 2012–2013 school year, federal requirements for school lunches mandated the inclusion of both fruit and vegetable choices, and students were required to take at least one half cup of fruits or vegetables. Over the course of the week, schools were required to offer all vegetable subgroups established in the 2010 Dietary Guidelines for Americans: dark green vegetables, red or orange vegetables, beans or peas, starchy vegetables, and “other” vegetables. In school years 2012–2013 and 2013–2014, it was required that half of the grain products offered in school lunches must be rich in whole grains. Adapted from the U.S. Government Accountability Office.

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children who were served meals meeting the new standards ate greater proportions of their en- trées and vegetables than they had when they were given meals meeting the old standards, even though the vegetable servings were larger; they also found that more children ate fruit when they were served the new meals. The findings suggest that children consume more fruits and vegeta- bles and do not waste more food under the new mandate.2

Proponents of the waivers also argue that many children dropped out of the school-lunch program as a result of 2012 changes to school meals. In fact, the num- ber of students paying full price for school lunch has been de- creasing by an average of nearly 5% annually since the 2007–2008 school year, while the number of students qualifying for free meals has been increasing. Several fac- tors may have led to an overall 3.7% decrease in student participa- tion from the 2010–2011 school year through the 2012–2013 school year, including the recession, price increases for full-price partici- pants, students’ wariness of new foods, and negative media cover- age of school-lunch content. In a January 2014 report, the Govern- ment Accountability Office noted

that it was unclear how much each of these factors con-

tributed to changes in program participation and did not recom- mend changes to the new nutri- tion standards.3 Many school of- ficials expect some of these challenges to diminish over time, as schools and students become accustomed to the new program — and indeed, reports of im- proved acceptance among stu- dents are emerging. In a nation-

wide survey conducted in the spring of 2013, 70% of school officials said they believed that elementary-school students liked the new meals.4

Finally, students’ taste prefer- ences are cited as a barrier to consumption of school meals that adhere to the new guidelines. But research demonstrates that children — even infants as young as 4 months old — who are re- peatedly exposed to new foods are more willing to accept them.5 Thus, repeated opportunities for children to try healthy foods cre- ate a pathway for improving nu- trition early in life.

Attempts to roll back the mod- ernization and improvement of school-meal standards threaten future progress in reducing obe- sity and other chronic diseases that originate in early childhood. After 30 years of escalating preva- lence of childhood obesity, recent plateaus suggest that progress has been made on many fronts. Federal improvements to school meals represented a key victory — yet now they are under attack. As pediatricians, we worry that this attack undermines schools’ ability to foster health-promoting behaviors and represents a disin- vestment in children’s health.

This past spring, the American Academy of Pediatrics, the Amer- ican Heart Association, the Acad- emy of Nutrition and Dietetics, and more than 200 other organi- zations joined First Lady Michelle Obama and Secretary of Agricul- ture Tom Vilsack in opposing the challenges to the new school- nutrition standards. Although cur- rent leaders of the SNA are vocal advocates for rollbacks and waiv- ers, a group of 19 past SNA pres- idents opposes the waivers.

We can help ensure that U.S.

children have access to healthy foods and reduce their risk of obesity. Waivers of new school- lunch standards would represent a large step backward. Instead, we believe that the scientific in- tegrity of school-meal standards should be maintained and that the U.S. Department of Agricul- ture should work with stakehold- ers to evaluate progress in imple- menting the new regulations.

The Robert Wood Johnson Commission to Build a Healthier America recommends that we create a “culture of health” for U.S. children. Doing so requires investing in physical and mental wellness beginning in early child- hood and creating communities that foster health-promoting be- haviors. Pediatricians can talk with children and their families about the importance of eating whole grains, fruits, and vegeta- bles. Parents can tell school offi- cials and lawmakers that they want healthy school meals. Schools can work with local chefs, dieti- tians, parents, and students to make school meals more appeal- ing and to incorporate culturally appropriate foods.

The prevalence of childhood obesity has increased sharply over the past 30 years. It will take time to reverse this trend, but recent plateaus in obesity rates suggest that multipronged initia- tives spanning health care, pub- lic health, and education settings are well worth the effort. School nutrition is a matter of children’s health; it should not be driven by politics.

Disclosure forms provided by the au- thors are available with the full text of this article at NEJM.org.

From the Department of Pediatrics, Boston Children’s Hospital ( J.A.W.B.), the Depart- ment of Pediatrics, MassGeneral Hospital

Protecting Progress against Childhood Obesity

An audio interview with Dr. Woo Baidal

is available at NEJM.org

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for Children ( J.A.W.B., E.M.T.), and the De- partment of Nutrition, Harvard School of Public Health (E.M.T.) — all in Boston.

This article was published on October 29, 2014, at NEJM.org.

1. Committee on Nutrition Standards for National School Lunch and Breakfast Pro- grams. School meals: building blocks for healthy children. Washington, DC: National Academies Press, 2010 (http://www.nap.edu/ openbook.php?record_id=12751).

2. Cohen JF, Richardson S, Parker E, Catalano PJ, Rimm EB. Impact of the new U.S. Depart- ment of Agriculture school meal standards on food selection, consumption, and waste. Am J Prev Med 2014;46:388-94. 3. Government Accountability Office. School lunch: implementing nutrition changes was challenging and clarification of oversight re- quirements is needed. February 27, 2014 (http://www.gao.gov/products/GAO-14-104). 4. Turner L, Chaloupka FJ. Perceived reac- tions of elementary school students to changes in school lunches after implemen-

tation of the United States Department of Agriculture’s new meals standards: mini- mal backlash, but rural and socioeconomic disparities exist. Child Obes 2014;10:349- 56. 5. Forestell CA, Mennella JA. Early determi- nants of fruit and vegetable acceptance. Pedi- atrics 2007;120:1247-54.

Protecting Progress against Childhood Obesity

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