BIO, PhRMA split on special use pathway

The leaders of the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America staked out separate positions on the creation of a Special Medical Use pathway proposed by the President's Council of Advisors on Science and Technology and senior FDA officials. The pathway would allow streamlined development programs for drugs targeted at well-defined, high-risk subpopulations, such as infection with a multi-drug resistant pathogen or morbid obesity. The pathway would include special labeling and other measures intended to deter use outside the limited population (see BioCentury Feb. 25).

Speaking at a Brookings Institution meeting to discuss the pathway, BIO President and CEO James Greenwood said the group's board "strongly approves" of SMU, endorses congressional action to create the pathway and feels it should be "broadly applied" to drugs for a wide range of diseases. John Castellani, PhRMA's president and CEO, declined to endorse creation of an SMU pathway and said FDA has sufficient authority to approve drugs for special populations, though he stressed the urgency of facilitating development of new anti-infective drugs. Members of Congress have indicated that enactment of legislation creating an SMU pathway is contingent on unanimous support from industry, so PhRMA's skepticism about the need for an SMU pathway could scuttle the concept. ...