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Feb 25, 2013
 |  BioCentury  |  Regulation

Limiting 'Limited-Use'

Controversy could restrict FDA's limited-use pathway to anti-infective drugs

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.

Restricting the pathway to anti-infectives would allow FDA to address a public health crisis and test drive the concept, but would disappoint patient advocacy organizations and emerging biotech companies that hope the regulatory tool could speed development and approval of new drugs for a variety of conditions.

In fact, no one has released a detailed blueprint for a limited-use pathway, and there are a wide range of ideas about how it would work.

The basic concept is for FDA to allow extremely streamlined development programs for drugs for well-defined subpopulations for which benefits clearly outweigh risks, and to couple expedited approvals with measures intended to discourage inappropriate off-label prescribing.

The lack of specifics and distrust of the agency's intentions have led some critics to assume FDA is seeking a broad expansion of its power over the practice of medicine, and others to accuse the agency of plotting to allow dangerous under-tested drugs on the market (see BioCentury, Jan. 28).

Left, right

PCAST's recommendation, which was based on discussions with FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, and FDA's subsequent call for public comment on the approach, have been assailed from both sides of the political spectrum.

On the left, consumer groups and some prominent physicians warn that FDA's existing accelerated and breakthrough pathways already expose patients to too much risk, that the agency should slow rather than expedite approvals, and that FDA should have far more power to limit off-label prescribing.

"This pathway would promote unproven drugs to high-risk patients," said Jennifer Yttri, a senior fellow at the consumer group National Research Center for Women & Families, at a Feb. 4 meeting FDA convened to collect comments about the proposed pathway.

"We know there...

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