The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Addressing the Barriers to Pediatric Drug Development: Workshop Summary
dominate the vaccine market. Exclusivity is not an incentive because there are no competitors waiting to produce generic versions of vaccines.
Several incentives do exist for vaccine development, some by virtue of what vaccines do and how they are distributed, and some that were put in place specifically to spur development. Vaccine makers are often guaranteed a large market because of universal vaccination policies that reflect standards of care set by recommending bodies. Vaccines are fundamental to pediatric practice and are a regular component of well-clinic visits. Moreover, vaccination often offers protection to the community as well as to individuals; therefore, many vaccines are eventually mandated through school and/or day care laws.
Because vaccines are mandated to provide a community benefit, Congress established the National Vaccine Injury Compensation Program as Title XXI of the Public Health Service Act of 1987. The program offers a no-fault compensation system for patients (or their families) who suffer serious adverse reactions from required childhood vaccines. The aim is to help stabilize the supply and price of vaccines by removing most of the liability burden from manufacturers for immunization-related injuries. The program is funded by an excise tax of $0.75 on every dose of covered vaccine that is purchased.
Also in place is the Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program that collects information about adverse events occurring after the administration of U.S.-licensed vaccines. Reports are made by vaccine manufacturers, health care providers, state immunization programs, vaccine recipients, and other sources. VAERS is a passive system (meaning that reporting is generally voluntary), though certain adverse events are required to be reported by law. Two-page public information fact sheets on each vaccine describing benefits and risks, issued by the government and written for the lay public, also stimulate reporting by consumers. In addition, the Vaccine Safety Data Link (VSDL) was established to monitor immunization safety and address gaps in knowledge about rare and serious side effects associated with immunizations. It monitors rates of adverse events from eight managed care organizations that cover roughly 2 percent of the population. VAERS works by identifying signals that indicate there may be a problem, while VSDL is better for assessing causality.
Dr. Orenstein suggested that two components of vaccine development might transfer well to pediatric drug development: the fact sheets used for vaccines would likely be helpful for pediatric drugs as well, and a no-fault compensation system could remove a barrier to the industry’s testing and distribution of products among pediatric populations. Dr. Orenstein also suggested development of a document similar to the Red Book, a pediatric infectious disease reference