STRATEGIC PLAN - ASPE - U.S. Department of Health and Human ...

CHAPTER 5: Scientific Research and Developmentis the fact that the number of new drugs and othertreatments approved each year for use in the UnitedStates is steadily dropping, in no small part becausescientists test new discoveries using outdated andinefficient tools and techniques. The result is a slow,expensive process. It produces fewer and fewertreatments that can be approved as safe and effective,and it leaves consumers on their own to grapple withthe question marks of treatment and a short list ofprevention options.One of HHS’s primary strategies for reversing this trendis through the FDA Critical Path Initiative (CPI). TheCPI identifies and prioritizes the most pressing medicalproduct development problems and the greatestopportunities for rapid improvement in public healthbenefits. The goal is to stimulate the development ofpowerful new scientific and technical tools—such asproven biomarkers, innovative clinical trial designs,simulation models of physiology and disease processes,and manufacturing quality assessment methods—capable of rapidly predicting the safety, effectiveness,and quality of new medical products. Developmentof these tools will be based on an understanding ofthe most successful practices as well as the failures,roadblocks, bottlenecks, and missed opportunitiesalong the way.Business InterestsWithin the research and development sector, businessdecisions, such as technical capabilities, competingopportunities, interest in the field to develop basicfindings into next steps or the next generationof science, economic motivations, public healthmotivations, and other considerations, significantlyinfluence research and development progress. Forexample, during the last half-century, pharmaceuticalcompanies have been gradually abandoning thedevelopment and manufacture of vaccines. Today,fewer companies are making vaccines because of anumber of factors, including the expense involved inbringing vaccines to market and the small size of thevaccine market compared to the larger drug market.There does not appear to be a single reason to explainthe decline in the number of vaccine manufacturers.High-risk research that is critical to biomedicaladvances must often be initiated by public agencies;because of the high risk of failures, private for-profitgroups may be less likely to pursue this type of research.A larger trend in pharmaceutical company mergers andacquisitions, which has seen vaccine-only companiesacquired by larger manufacturers, has also contributedto the decreases in the total number of companiesmaking vaccines. In the 1990s, these mergers andacquisitions were largely driven by the need to cut costs.Companies are merging and acquiring other companiesin order to secure enough capital and expertise totake advantage of these innovations and, at the sametime, cut costs and create efficiencies. The concernremains, however, that leaving the manufacture of allvaccines in the hands of so few producers leaves thesupply vulnerable to disruptions and shortages as hasbeen observed in recent years regardless of the totalcapacity to produce vaccines. HHS is working withmanufacturers to identify incentives to promote marketreentry and capacity expansion.Intellectual PropertyIntellectual property issues also influence theadvancement of science. HHS is working to devisecreative incentives to promote the sharing ofknowledge among researchers. HHS is also workingas a member of the global community to promoteknowledge sharing across countries through formaland informal channels.Recruiting and Retaining ExpertiseThe scientific labor market is highly competitive. Ahighly competitive labor market may impact HHS’sability to recruit and retain scientific experts toconduct and oversee research activities and to reviewapplications for medical products. HHS will workto address this challenge by developing training andfellowship programs, as well as partnerships withacademia, to enhance the pool of qualified scientists.HHS Strategic Plan FY 2007-2012131