FDA is responsible for addressing concerns regarding the safety of medical products, in particular, drugs. As the science of drug development continues to evolve, FDA will continually improve the approach to drug regulation to ensure that care providers and patients can make optimal decisions about the medicines they use to improve their health. FDA’s reform effort will include developing new tools for communicating information to patients and improving the management of the process for how FDA uncovers and communicates important drug safety issues. For example, FDA will focus on improving the safety of drugs on the market in part through its plans to modernize the Adverse Event Reporting System (AERS) and establish “AERS II” as the primary source for drug product adverse event data. These resources also will allow FDA to augment AERS data and further its efforts with CMS to obtain access to valuable drug safety information housed in CMS population-based databases. This collaboration with CMS will be integrated with the Sentinel System, a seamless platform for gathering and evaluating information about adverse events related to the use of medical products. This integration will enable FDA to gather more information from the point of care about potential safety problems and will provide a framework for turning these raw data into useful knowledge about the safe use of medical products.
In order to improve current processes and systems for collection of adverse events and errors, FDA is developing MedWatch Plus. This program will provide a single internet portal for anyone needing to report an adverse event resulting from an FDA regulated product, including product complaint reporting. This initiative will improve the collection and processing of adverse event information for all FDA regulated products. The user-friendly electronic submission capability will facilitate submission of adverse events reports to better allow FDA to efficiently and effectively use the information to promote and protect public health. Through these modernization efforts, FDA will continue to ensure that the medical products it regulates are the safest in the world.
OPHS coordinates vaccine safety activities among HHS agencies which conduct a broad range of activities aimed at ensuring the safety of vaccines. NIH conducts and funds basic research that leads to the development of vaccines with a major emphasis on safety. FDA has statutory responsibility for licensing vaccines. Additionally, the FDA coadministers the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, with CDC. CDC also conducts active surveillance of vaccine associated adverse events through the Brighton Collaboration, and examines vaccine adverse events on the practice level through Clinical Immunization Safety Assessment (CISA) centers. HRSA compensates individuals who may have been injured by vaccines through the Vaccine Injury Compensation Program (VICP). The Federal government has a heightened responsibility to ensure that vaccines are optimally safe as vaccines are recommended for nearly ever child in the U.S. and children are required by state laws to receive vaccines in order to enter school. OPHS is coordinating an interagency strategic plan to enhance HHS vaccine safety activities. Vaccine safety activities will be enhanced in the areas of research and development, post-licensure surveillance, and risk communication.
Generic Drugs. Part of FDA’s mission is to make sure that the generic drugs approved for use in the United States are just as safe and effective as the brand-name versions of the drugs. Generic drugs can be very helpful for patients because their price is typically much lower: For the average price of a brand-name prescription drug that is $72, the average price of a generic version is about $17.xiii This is an especially important source of drug savings at this time, because a growing number of important brand-name medications—more than 200 in the next few years—are coming off patent, paving the way for the development of generic versions. FDA’s new final regulation to improve how and when generic drugs can compete with brand-name drugs will lead to saving billions of dollars in drug costs each year.
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