SAVA - Cassava Sciences citizen petition saga shines light on alleged abuse of FDA program

The FDA's rejection on Thursday of a citizen petition related to Cassava Sciences' (NASDAQ:SAVA) experimental Alzheimer's treatment simufilam has rekindled a long-time debate over how the petitions are being used by some, especially rival companies and those with deep pockets. The ability to file a citizen petition to the U.S. Food and Drug Administration was created decades ago to allow individuals and organizations to seek changes to health policy that FDA has purview over. However, the petitions are now often utilized by companies -- more often than not for the purposes of financial gain. In particular, the petitions are often filed by brand drug companies looking to stave off competition from generics hitting the market. Such petitions appear designed to delay generics from coming to market, preserving revenue for the brand company. This "gaming" hasn't gone unnoticed, with the FDA issuing new guidance in 2019 to address this. In reality, however,

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Cassava Sciences citizen petition saga shines light on alleged abuse of FDA program