In February 2004, Presdent Bush appointed Mark McClellan, then FDA Commissioner, to run Medicare. McClellan, brother to White House Press Puppeteer Scott McClellan, had earned a reputation for modernizing the FDA and streamlining the drug approval process. Whatever one thinks of McClellan's priorities at the FDA, he was clearly a strong leader, and gave the agency focus and direction it had been lacking.
Since February 2004, the FDA has been run by Lester Crawford in the role of acting director. Crawford's priorities in August 2004 give no indication of the coming flu vaccine shortage, and are in many regards a restatement of McClellan's priorities. The FDA has had other issues to deal with, from the withholding of data linking antidepressant use in adolescents to increased risk of suicide, to conflicts of interest of FDA and NIH researchers, to the withdrawal of Vioxx by Merck. Even without these issues, an acting Commissioner is in no position to provide leadership the FDA needs, and Bush has been in no rush to nominate a replacement for McClellan.