A new expedited limited-use drug approval pathway that was recommended by the President's Council of Advisors on Science and Technology and senior FDA officials is falling victim to concerns from big pharma companies that the scheme could become a tool for the agency to narrow approved indications and to bar off-label prescribing.

As a result, rather than apply to all serious or life-threatening conditions, any new limited-use pathway is likely to be restricted, at least initially, to anti-infective drugs.