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Akron Univ. School of Law

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Tuesday, February 7, 2006

FDA's Leadership, Management Examined

From the Kaiser Family Foundation's Daily Health Policy Report:

  • Baltimore Sun: The Sun on Saturday examined leadership at FDA, noting that the agency has "seen no fewer than four interim commissioners over all but 18 months of the Bush presidency." Most recently, the White House appointed Andrew Von Eschenbach to be acting FDA commissioner. The position has been led by acting commissioners for long periods under other presidents, the Sun reports. However, the lack of a permanent leader has "generat[ed] growing concern from members of Congress from both parties, various interest groups and industry," according to the Sun. A spokesperson for Rep. Mark Souder (R-Ind.) said a "continuous 'interim director' at FDA is like a baby sitter left in charge of the children indefinitely -- you don't want to leave important decisions to that person." Some former officials say that the lack of a permanent commissioner might "reflect the difficulty of finding someone acceptable to conservatives, industry and other interest groups," the Sun reports. Erin Healy, a spokesperson for the White House, said the Bush administration aims to nominate a permanent commissioner as soon as possible (Rockoff, Baltimore Sun, 2/4).
  • Washington Post: FDA has reached its highest-ever backlog of generic applications, with more than 800 applications to bring new generic drugs to the market, the Post reports. The Office of Generic Drugs in December 2005 received an all-time monthly high of 129 applications, according to Gary Buehler, the office's director. Last year, the agency approved 450 applications, down 23 from 2004, and took an average of 20.5 months to review each application. The current law requires FDA to review applications within six months. Buehler said he expects a record number of generic drug applications in 2006, adding that he also anticipates a backlog because the office will not be receiving any staff increases. He said, "We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog." Former FDA Commissioner Lester Crawford in testimony last summer before Congress said that the agency was approving an average of one generic drug application per day, saying that the "system seems to be working" and that the agency did not need additional staff members in the generics office. Rep. Henry Waxman (D-Calif.) said, "This huge backlog of generic applications is just unacceptable. This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind" (Kaufman, Washington Post, 2/4).

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