The FDA backlog is expected to balloon in the next few years. An unprecedented $60 to $70 billion worth of brand-name drugs — such as Zocor, Zoloft, Pravachol and Ambien — will come off patent in the United States over the next four years, creating opportunities for spirited generic competition and greatly reduced prices.

"It's pretty simple: The more generics we have, and the more quickly we get them, the more savings for consumers," said Steve Miller, author of the recent Express Scripts study, which estimated wider generic use could have saved $20 billion in 2004 alone. Mark Merritt, president of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers, said 90 percent of the time doctors and patients agree to switch to a newly approved generic by the next refill.

But without an increase in staffing at the Office of Generic Drugs, advocates of generics say, the public will get those savings more slowly, and sometimes not at all.

The view within the FDA appears to be quite different. In testimony before Congress last summer, former FDA Commissioner Lester Crawford said the agency was approving on average one generic drug per day, calling that a sign that "the system seems to be working" and "we are meeting our deadlines." He said there was no need for additional staff in the generics office.

Some at the FDA and in the industry say the answer is to do what brand-name drug makers did in the early 1990s — have generic companies pay "user fees" to finance new hires by FDA. Today, user fees support about half the FDA staff that reviews — and speeds — new drug applications.

But the generic drug industry includes hundreds of small firms, and its leaders say they can't reach consensus on whether to accept user fees. Others argue that since the low cost of generics has broad benefits for the public, Congress should be willing to pay for added staffing. That the administration has not asked for more money, some say, indicates that it favors the big drug companies.

"The branded industry has to be delighted by this backlog," said Jake Hansen, vice president for government affairs for generics maker Barr Laboratories Inc. "If they can't stop competition in the courts, stopping it as applications go through the regulatory process is just as effective. For consumers, to flatline or cut funding makes absolutely no sense."