McClellan moves on after short, but challenging time at FDA

Related tags George w. bush Dietary supplement Fda

Mark McClellan is to leave his post as Commissioner of the US Food
and Drug Administration (FDA), shortly after implementing the
agency's first ban under the 1994 Dietary Supplement Health
Education Act.

President George W Bush has nominated Dr McClellan as his preferred candidate to head up the Centers for Medicare and Medicaid Services.

Dr McClellan will be missed by the pharma industry as he has been responsible for putting in place a number of reforms, including some designed to reduce the time the agency takes to review new drug applications. He has also been popular with the dietary supplements industry and the recent decision to ban the weight loss herbal has been welcomed by many as a sign of recognition that the agency does indeed retain powers to regulate supplements under DSHEA.

The ban, published earlier this month, sets a precedent for the supplements industry, which can expect further rule-making instead of waiting for case-by-case enforcement on ingredient safety issues, said the NNFA recently.

"The bottom line of FDA's lengthy scientific discussion is that it seriously raises the bar on safety substantiation. A key indicator for future supplement challenges is FDA's rejection of the safety studies because they were not designed to detect serious effects in susceptible individuals-and because the studies were too small,"​ said the trade association.

An initial consequence will likely be further FDA investigation into ephedra alternatives, with McClellan singling out bitter orange, aristolochic acid and usnic acid as those with high potential risks last month.

However it is not yet clear whether FDA Deputy Commissioner Lester Crawford, who previously led the agency from February to November 2002, and looks set to become the acting Commissioner at the FDA when McClellan leaves, will continue the campaign.

Meanwhile the industry is still waiting for debate on Senate and House bills seeking to amend DSHEA, including S722, the Dietary Supplement Safety Act. The future for the DSHEA 'Full Implementation and Enforcement Act', or S. 1538, which would provide additional funds for FDA to implement DSHEA instead of dismantling it, also remains undecided.

Related topics Regulation

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