Disease-Awareness Ads Thrive In Regulatory No-Man’s Land
FDA says its hands are tied when it comes to curbing practices such as the testosterone ads its advisory committees have found problematic, but are the agency’s powers really that limited?
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Sponsored plotline for General Hospital was careful to avoid irking US FDA; agency withdrew its guidance on disease awareness campaigns in 2015, but its influence appears to be continuing, according to a former official.
FDA proposal obtained by “The Pink Sheet” DAILY eliminates language describing symptoms of low testosterone.
Labeling updates will also clarify approved uses and warn of possible increased risk of heart attack and stroke; impact on products in development unclear.