“Openness in government strengthens our democracy, promotes the delivery of efficient and effective services to the public, and contributes to economic growth.”—President Barack Obama’s Executive Order - Making Open and Machine Readable the New Default for Government Information (May 9, 2013)
MFIA represents clients attempting to make government more transparent through increased access to government data. Our current cases include:
In September 2016, the FDA approved eteplirsen, a new treatment for Duchenne muscular dystrophy, a previously-untreatable fatal childhood disease. Eteplirsen received accelerated approval, which is available for drugs treating “serious or life-threatening diseases” that provide “meaningful” benefit over existing therapies. Sarepta satisfied FDA’s standard using a twelve-patient clinical trial and the surrogate endpoint of dystrophin production.