brennan center for justice

Results from the FDA’s Adverse Event Reporting System have been no less powerful. For example, in 1998shortly after the System’s launch, reports of liver injuries on the system resulted in the FDA’s removal of theanti-inflammatory drug Duract from the market. 228 More recently, a handful of reports on the system abouta serious condition affecting bone marrow of those taking the antibiotic Zyvox, led to a change to the drug’slabeling to inform providers about the risk of this reaction and recommendations for monitoring patients. 229We chose the CPSIA database as a model because it will be the most comprehensive publicly available“early warning” database ever created, and the CPSC has been developing it based upon lessons fromthe NHTSA and FDA databases with a desire to improve upon them by, among other things, makingthem more user-friendly. 230 Indeed, in CPSIA’s legislative history, a House Committee urges the CPSCto “examine these and other Agency efforts, if applicable, when designing its own database.” 231D. Key BenefitsA database that conforms to the specifications we have outlined would allow the appropriate governmentagency, vendors, and the public to efficiently access, evaluate, investigate, and share informationregarding voting system failures or vulnerabilities. This, in turn, would result in earlier detection ofsystem failures and vulnerabilities by vendors and election officials, and ensure more rapid responses tothose issues ultimately making it less likely that voting systems will malfunction on Election Day, whenit matters most. More specifically, however, the database would achieve the following objectives:Increase Election Official & Public Awareness ofProblems & Solutionsa national, searchable databaseThe database would allow election officials toeasily access and share information. For example, would allow election officials tothis would help to ensure that election officials ineasily access and share information.different states using the same make and model ofmachine or other voting system element would beaware of any problems the other had encountered using that equipment – if one official discovers avulnerability and posts this information to the database, the other official will be able to check his orher system to ensure that it does not also have that vulnerability. Moreover, if a vendor provides oneelection official with a procedural solution, such as a workaround to address a problem, the databasewould provide officials using the same voting equipment in other jurisdictions with that solution.Further, the database would provide voter protection groups, political parties and other concernedmembers of the public with more knowledge about potential voting system problems. Before anelection, they would, among other things, be able to determine whether there have been any issueswith the voting systems in their counties and, if so, to advocate corrective action before the election andbe on the lookout for similar problems during voting.Improve the Ability of Government and Others to Identify Failures or Vulnerabilities & Respond QuicklyThe database would allow the appropriate government agency, voter protection groups, and otherconcerned members of the public to mine the information on the database and spot patterns and trendsthat may indicate voting system failures or vulnerabilities. This is a key reason for allowing individualvoters to report problems they encounter. All of the databases hosted by federal agencies that wereviewed allow such reporting from the general public. After collecting and analyzing this information,the appropriate government agency would be able to more quickly launch an investigation to rectifythese potential vulnerabilities or failures.Brennan Center for Justice | 31