McClellan to quit as FDA chief?
that the US Food and Drug Administration has had in years, could be
leaving his position before the end of the month, according to
industry speculation.
Analyst Mark Tracey of Goldman Sachs said in a note to clients that the rumour is that Dr McClellan has been headhunted by the Bush administration to head up the US's new Medicare agency.
Commissioner McClellan has been credited with slashing review times for new products at the FDA but Tracey believes there will be little impact from this departure on reviews because his reforms are in place and working well.
However, he noted that other new initiatives, such as the FDA's new programme looking at routes for the approval of biological generics, could experience some delays. This would be positive for the biotechnology sector, he said. Either way, he expects the FDA to issue guidelines on generic biologics in the next one to two years.
Dr McClellan appears to be making the change due to concerns at the White House and within the Department of Heath and Human Services (HHS) that having a high profile administrator at the Center of Medicare and Medicaid services (CMS) to oversee implementation of the Medicare drug card and drug benefit is the top priority at the moment.
And if President Bush is re-elected, Dr McClellan is a likely candidate to replace Tommy Thompson as secretary of the Department of Health and Human Services, which oversees the FDA, according to GS.
As far as the Commissioner position at the FDA is concerned, GS expects someone will be appointed to fill the role on a temporary basis. This could be either Lester Crawford, who served as acting commissioner before Dr McClellan's arrival, or another senior staff member.
