Monday, September 27, 2010
FDA's decision to leave Avandia rosiglitazone on the
market with extraordinary restrictions on its use, a pathway for obtaining data
that could lead to an easing of the restrictions, and a commitment from GlaxoSmithKline
plc to cease promoting the diabetes drug, serves as a model for how
critical elements of an adaptive approval system could work.
The steps announced last week
are the most vivid example of how the regulatory flexibility created by the FDA
Amendments Act of 2007 allows the agency to move from a black-and-white stance
in which investigational drugs are considered dangerous and approved drugs are
treated as safe to a nuanced position in which access and use restrictions can
be adjusted. As such, they could provide insight into how FDA might deal with
similar situations in the future.