Joshua Sharfstein, the head of the Baltimore Health Department, is working with President-elect Barack Obama to asses what is wrong with the US Food and Drug Administration (FDA), giving credence to the belief that he will be the next Commissioner.
He has also worked for Henry Waxman, the new chairman of the House Energy & Commerce Committee, giving him further contacts on Capitol Hill.
Sharfstein has been a vocal critic of the pharmaceutical industry, slamming Pfizer for holding a marketing event in a pool hall and pushing for the FDA to stop the sale of over-the-counter cold medications to children.
These actions are unlikely to win Sharfstein many supporters from within the industry but nonetheless JP Morgan analyst Ipsita Smolinski placed him among the likely candidates for the post.
Sharfstein is joined by Steve Nissen on the list of candidates that pharma is unlikely to welcome with open arms. Nissen, a cardiologist at Cleveland Clinic, has in the past been vocal and tenacious in his challenges to the safety records of a number of products.
He has raised questions over the safety of Avandia (rosiglitazone) and Vytorin (ezetimibe/simvastatin) putting him at odds with many in the FDA and the pharmaceutical industry.
However, given that many people believe a serious overhaul of the FDA is required Nissen’s outspoken stance may work in his favour.
In addition, Nissen has given a speech that could be interpreted as him offering an olive branch to pharma. In the speech Nissen criticised the FDA for not completing drug reviews by the specified deadline, saying the resolution of this should be a top priority.
Although pharmaceutical companies would welcome this improvement at the FDA it is unlikely to be sufficient to put Nissen among pharma’s favourites.
Media reports suggest that the pharmaceutical industry favours Janet Woodcock, head of the FDA’s center for drug evaluation and research, but there is a belief that her appointment would represent maintenance of the status quo at a time when change is needed.
Woodcock has been at the agency since 1986 and the prospect of her being promoted to Commissioner, even on an interim basis, has been vociferously criticised.
Democrat Congressman Bart Stupak wrote a letter to Obama urging him to break from the current leadership of the FDA, urging the President-elect not to appoint any of them Commissioner.