Nissen's Exceptional Proposal

Steven Nissen arguably has done more than anyone else to push FDAto increase its demands for premarket cardiovascular safety data for drugs that will be used on a long-term basis to treat common chronic conditions. Now he wants the agency to lower the safety threshold for compounds that use novel mechanisms of action to lower LDL cholesterol, saying they should be given conditional approval based on a CV safety margin that includes the possibility of increased harm.

The agency hasn't reviewed Nissen's proposal, but it is skeptical about accepting uncertainty about CV harm for therapies that treat dyslipidemia...