[Ip-health] Reuters: FDA aims to speed generic drugs to market

[peter maybarduk]

<http://www.reuters.com/article/healthNews/idUSN0434207720071004>

FDA aims to speed generic drugs to market
Thu Oct 4, 2007 2:23pm EDT

By Kim Dixon

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on
Thursday said it approved one-third more generic drugs last fiscal
year and said it planned to speed review of these cheaper versions of
brand-name drugs.

Officials said the push includes an expedited review process using an
updated electronic format and team reviews of multiple applications
for the same product.

The FDA said it approved a record 682 generic drugs in fiscal year
2007 ended last week and faces a backlog of 1,300 applications, up
from about 800 about a year ago.

"These applications represent a vast scope of products -- and over
half are still protected by patents. There is no way we could approve
all of these applications," Gary Buehler, FDA director for generic
drugs, told reporters on a conference call.

"We had no anticipation that the number of generic applications would
skyrocket as it did" in the past several years, he added.

The use of generic drugs has dramatically increased in recent years,
as blockbuster drugs lose patent protection and healthcare costs rise.

The Generic Pharmaceutical Association, which represents most of the
industry, called the generic review effort weak.

The group wants limits on the practice of brand-name drugmakers
petitioning the agency to stop generic applications, which holds up
approval times substantially. The group also called for more
resources, not part of the FDA's plans.

"Another initiative in name only simply will not get the job done,"
Kathleen Jaeger, president of the group, said.

"For years, the agency has tinkered around the edges with programs
and initiatives designed to increase efficiency but have proven to
yield little in the way of significant results."

The agency said it might get more resources under a request now
before the U.S. Congress, but its plans are based on its current
funds and staff.

The agency said it received 880 generic applications in fiscal year
2007, compared with 792 applications in fiscal year 2006.

Unlike their brand name counterparts, generic drug companies do not
pay user-fees to help fund review of applications. The industry
opposes the fees.

Top generic drugmakers include Teva Pharmaceutical Industries Ltd,
Barr Pharmaceuticals Inc, Mylan Laboratories Inc, Watson
Pharmaceuticals Inc and Novartis AG's Sandoz unit.

(Reporting by Kim Dixon)