[Mb-civic] Generic Drugs Hit Backlog At FDA - Washington Post

[William Swiggard]

Generic Drugs Hit Backlog At FDA
No Plans to Expand Review Capabilities

By Marc Kaufman
Washington Post Staff Writer
Saturday, February 4, 2006; A01

At a time when the use of low-cost generic drugs is being embraced as 
one of the few ways to rein in skyrocketing health care costs, the Food 
and Drug Administration has a backlog of more than 800 applications to 
bring new generic products to the market -- an all-time high.

As a result, experts say, fewer generic drugs will be available to 
consumers in the years ahead than the industry is ready and able to 
provide. The FDA, however, has told Congress that the office that 
reviews new generics needs no additional money, and the agency has no 
plans to hire more reviewers.

"We are very aware that many, many people are waiting for more generics 
to be approved and that there is frustration about the backlog," said 
Gary Buehler, director of the agency's Office of Generic Drugs.

He said he expects a record number of applications this year -- and an 
even larger backlog -- because "we don't believe we'll be getting any 
staff increases in 2006." Buehler said his office received an all-time 
monthly high of 129 applications in December.

The Bush administration has strongly advocated generics as a way to hold 
down health care costs, and the director of the Centers for Medicare and 
Medicaid Services, Mark B. McClellan, said in an interview this week 
that an ever-growing number of generics is essential to controlling the 
cost to the government and seniors of the new Medicare prescription drug 
program.

In a recent federal report on health care costs, one of the few bright 
spots was a slowdown in the rate of prescription drug spending that was 
credited largely to the growing use of generics, which now account for 
more than half of all prescriptions.

"This huge backlog of generic applications is just unacceptable," said 
Rep. Henry A. Waxman (D-Calif.), one of the sponsors of the law that 
made generics more easily available two decades ago. "This is the time 
for the FDA to be ramping up its generic reviews, not to be falling so 
badly behind."

Last year, the generics office approved more than 450 applications, 23 
fewer than the year before. The office took an average of 20.5 months to 
review each application, compared with 19.9 months in 1999, although by 
statute the agency is obliged to do the job within six months.

The FDA's Buehler said the agency gives priority to "first generic" 
applications, for drugs just losing patent protection, but documents 
show that the backlog for all generics is double what it was just three 
years ago.

As the backlog of generic applications has soared, the number of 
applications for new or reformulated drugs and biologics submitted by 
brand-name companies has remained consistently smaller than predicted. 
But while the Office of Generic Drugs had about 200 employees to process 
almost 800 new applications last year, the offices that review new drugs 
had more than 2,500 employees for about 150 applications in 2004.

The generics office's budget was about $26 million last year, a fraction 
of the more than $400 million spent to evaluate and monitor new drugs 
and biologics, according to FDA documents. In response to questions from 
Congress, the agency said the generics program would have to make cuts 
in 2006 to offset pay raises.

"We have a kind of crazy situation now where the FDA's generic reviews 
-- which are supposed to be quicker because they're less complicated -- 
on average take longer than the new drug reviews," said Kathleen Jaeger, 
president of the Generic Pharmaceutical Association. "The flood of 
applications is coming in generics, but the review resources mostly go 
to new drugs."

A generic drug, which comes on the market after another drug's patent 
expires and must have the same active ingredients as the drug it mimics, 
usually costs 60 to 90 percent less than the brand-name version. The 
cost drops the most with the first generic alternative to a brand-name 
drug, and it falls more as each new competitor reaches the market.

Consumer acceptance of generics has increased markedly in recent years. 
Drug experts say the tidal wave of demand reflects the high price of 
branded products, the large number blockbuster drugs going off patent, a 
big push by insurers and the government to encourage generic usage, and 
an influx of cheap medicines made by Asian manufacturers. These 
companies are filing applications to market drugs just coming off patent 
as well as lesser-used older medications that do not have generic 
competition.

Generic drugs now account for about 12 percent of the nation's $250 
billion a year in drug spending and more than 53 percent of 
prescriptions filled. IMS Health, a company that tracks the industry, 
predicts that the percentage will exceed 65 percent within four years as 
several blockbuster drugs go off patent. Express Scripts, which manages 
pharmacy benefits for many insurers, estimates that the figure could be 
70 to 75 percent by 2010.

Drug experts say more widespread use of generics could save billions. 
The Express Scripts study estimated that wider generic use could have 
saved $20 billion in 2004 alone. But because many generic drugs are 
antibiotics or other drugs that treat short-term conditions -- rather 
than the chronic problems treated by brand-name cholesterol, 
blood-pressure and antidepressant drugs -- only 37 percent of drugs 
dispensed, as opposed to prescriptions, are generic, according to IMS 
Health.

The FDA backlog is expected to balloon in the next few years. An 
unprecedented $60 billion to $70 billion a year in 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 Express Scripts study.

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, then-FDA Commissioner Lester M. 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 that "we 
are meeting our deadlines." He said there was no need for additional 
staff in the generics office.

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

But the generic drug industry includes hundreds of small firms, and its 
leaders say they cannot 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 Barr Laboratories 
Inc., a maker of generic drugs. "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."

Sharon Levine, who oversees drug utilization for the Kaiser Permanente 
health plan in Northern California, said it is essential for the FDA to 
speed the approval of new generics.

"The agency has done a good job of getting a wide range of generics onto 
the market so far, so it's worrisome if that flow might be slowing 
down," she said.

http://www.washingtonpost.com/wp-dyn/content/article/2006/02/03/AR2006020302598.html?referrer=email
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