Compassionate use of experimental drugs involves physicians prescribing unapproved treatments for patients who don’t have any other satisfactory alternatives on the market.
The decision follows the FDA’s possible deferral of Serapta Therapeutic’s muscle-wasting drug eteplirsen after an advisory panel determined the treatment was not effective. As of now, no other treatments for Duchenne muscular dystrophy are on the market.
While the FDA will allow drug companies to charge for an unapproved drug, it cannot force government or private health insurers to pay for these drugs.
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