Pharmacy Times, Volume 0, 0

Acting FDA Commissioner Andrewvon Eschenbach,MD, came under fire onCapitol Hill for the agency's slow-footedapproach to approving the sale of newgeneric drugs. During testimony beforethe House Agriculture AppropriationsSubcommittee, congressmen from bothparties expressed concern over recentreports that the FDA's backlog of genericdrugs awaiting approval has grown tomore than 800 applications.

Although the Bush Administration hasasked for a substantial budget increasefor the FDA in 2007, most of that moneywill be earmarked for "pandemic preparedness"and protecting the food supplyfrom terrorist attacks. Despite thegrowing approval backlog, the FDA hasnot asked for any increase in funding forits Office of Generic Drugs (OGD).

In his testimony before the subcommittee,Dr. von Eschenbach said theagency has no plans to increase the200-member staff at OGD, even thoughthere is evidence that the office willreceive even more abbreviated newdrug applications for generics during2006. Although the law requires theFDA to complete its review of eachapplication within 6 months, last yearthe generics office took an average of20.5 months to accomplish that—upfrom 19.9 months in 1999.