Scientific, Economic, Regulatory, and Ethical Challenges of Bringing Science‐Based Pediatric Nutrition Products to the U.S. Market and Ensuring Their Availability for Patients

Abstract

Many nutrition products and related drugs are unavailable or not consistently available to clinicians despite a body of clinical data and experience supporting their use. Many of these can be related to drug shortages that have increased since 2009. In addition, there are potentially useful products that are not approved for a specific use or are no longer being manufactured. This review broadly examines the product availability gap from the perspectives of a clinician/former nutrition industry medical director and an economist. The process of pediatric nutrition product and related drug innovation, as well as its drivers and the steps involved in bringing a product to market, is first described. This is followed by an assessment of factors influencing product availability beyond the innovation process, including regulatory issues, manufacturing compliance, purchasing practices, and other factors related to drug and nutrition product pricing and reimbursement. Three pediatric case examples are reviewed and placed in the context of the prior review. Last, recent and future possible steps toward closing the product availability gap are discussed.

Ethical issues in the development and implementation of nutrition-related public health policies and interventions: A scoping review

“…Six articles address vitamin/mineral supplementation [ 67 , 74 , 104 , 151 , 173 , 174 ] and six comment on food fortification [ 61 , 96 , 164 , 166 , 167 , 175 ] (see Table 1 ). No article specifically focuses on the ethical issues that could be raised by vitamin/mineral supplementation.…”

“…No article specifically focuses on the ethical issues that could be raised by vitamin/mineral supplementation. The contexts in which vitamin/mineral supplementation is addressed are various; for instance: needs for additional skills and knowledge of pharmacists to support appropriate nutritional advice to consumers in pharmacy settings and marketing practices [ 67 ]; lack of clinical access to specific innovative nutrition/vitamin products and regulations about food labelling and health claims [ 173 ]; lack of education in populations about the use of vitamin supplements [ 174 ]; limitations of observational evidence in vitamin supplementation [ 74 ]; and risks associated with the combination of public health interventions of different natures, such as vaccines and vitamin A supplementation [ 151 ]. Similarly, food (or water) fortification is not the subject of extensive ethical analysis, except in regard to states and other stakeholders’ accountability and to the benefits of such interventions (see Table 1 ).…”

Types of diet in enteral nutrition in children – short review

“…In children fed enterally, the most commonly used method is continuous nutrition with a constant controlled volume. The continuous infusion is carried out by gravity or using a nutritional pump (the infusion rate is usually 30-50 ml / hour) [6,7,11].…”

New insight of parenteral nutrition in children – short review

“…They should be used in accordance with daily requirements and current serum concentration. Their concentration in the blood serum of newborn babies born prematurely, should be controlled daily for the first 3-7 days of life or more frequently [8,51,54,56,57]. Sodium is the main electrolyte of extracellular fluids, whereas potassium is primarily found inside the cells.…”

“…Sodium is the main electrolyte of extracellular fluids, whereas potassium is primarily found inside the cells. These elements are responsible for the exchange of substances through the cell membrane and the spread of electrical stimuli in the nerve fibers [7,51,56,57].…”