[Ip-health] Biotech pushes for Biogenerics Bill in 2008, Generic Manufacturers want "Meaningful" legislation

[Sarah Rimmington]

1. AP: Biotech pushes for Generics Bill in 2008, by Matthew Perrone, 2/14/0=
8
2. Chicago Tribune: Bush plan would allow generic biotech drugs, by
Bruce Japsen, 2/14/08
3. Press release: Coalition for a Competitive Pharmaceutical Market
Launches New Print Ad Campaign Highlighting Need for Meaningful
Biogenerics Legislation, 2/14/08

[snip from AP story]

"With nowhere else to turn, BIO and PhRMA now want to come to the table
to cut a deal," said Kathleen Jaeger, President of the Generic
Pharmaceutical Association, speaking at that group's annual meeting on
Tuesday.

"They want unprecedented and excessive market exclusivity and patent
protections to ensure their monopolies."

The biotech industry says drugs must be on the market at least 12 years
before competing generics can launch. The generic industry backs
proposals for less than five years of exclusivity.

The two industries also disagree on how ready the FDA is. Whereas
generic advocates would like FDA to start reviewing products
immediately, biotech wants new regulations in place first _ a process
that could take years.
[snip]

1. http://www.chron.com/disp/story.mpl/ap/fn/5542691.html
Feb. 14, 2008, 3:18PM
Biotech pushes for Generics Bill in 2008
By MATTHEW PERRONE AP Business Writer
=A9 2008 The Associated Press


WASHINGTON =97 After nearly a decade of resisting, biotech companies want
a law passed this year that lets generic drug companies sell cheaper
copies of their medicines.

Biotechs have never had the competition from generics that makers of
chemical-based drugs, like Pfizer Inc. face when their patents expire.
The Food and Drug Administration lacks authority to approve generic
biotech drugs, but several bills introduced in Congress during the past
year would change that.

Biotech companies say they are ready for that change _ so much so that
their main trade group is making the legislation a top priority in 2008.
And the Bush administration recently said it supports that aim.

The industry's shift comes as election-year politics are expected to
shift Washington away from biotech's interests. Many political observers
expect Democrats to gain more power in Congress this November, which
could tilt favor to the generic drug industry. Faced with that
possibility, the biotech industry wants an agreement as soon as possible.

"We've made good progress in having this issue understood by the people
who are in place on Capitol Hill now," Biotech Industry Organization
President Jim Greenwood, told reporters at a press event in Washington.
"And we'd like to get it done this year so we don't have to start all
over again."

The group spent more than $3.6 million lobbying Congress and federal
agencies on issues including generic biotech in the first half of 2007.

The group also must factor in leading presidential candidates _ Sens.
Barack Obama, Hillary Clinton and John McCain _ who have all advocated
generic drugs as health care cost-cutter.

The U.S. currently spends $40 billion per year on biotech drugs,
including Genentech's cancer drug Avastin, which costs more than $50,000
for a year's supply. With those costs expected to rise, generic biotech
could prove an attractive cost saver for future administrations.

The Bush administration, which had previously been silent on the issue,
said earlier this month it would like to see FDA gain the power to
approve biogenerics this year. And FDA officials have also pledged to
work with lawmakers on a bill.

The biotech group is working now to negotiate guidelines favorable to
its members.

Getting legislation to the president's desk, say analysts, won't happen
until companies and Congress can hammer out disagreements on when and
how generic copies of biotech drugs are approved.

Lehman Brothers analyst Tony Clapsis told investors in a recent note
that "the more constructive attitude from the biotech industry and the
FDA will help to develop a consensus in Congress about how to move
forward, but that moving forward will happen in 2009."

The generic drug industry is content to wait until then, instead of
playing by a timetable set by biotech and pharmaceutical companies.

"With nowhere else to turn, BIO and PhRMA now want to come to the table
to cut a deal," said Kathleen Jaeger, President of the Generic
Pharmaceutical Association, speaking at that group's annual meeting on
Tuesday.

"They want unprecedented and excessive market exclusivity and patent
protections to ensure their monopolies."

The biotech industry says drugs must be on the market at least 12 years
before competing generics can launch. The generic industry backs
proposals for less than five years of exclusivity.

The two industries also disagree on how ready the FDA is. Whereas
generic advocates would like FDA to start reviewing products
immediately, biotech wants new regulations in place first _ a process
that could take years.

"The biotech industry's idea of a bill is one that will make sure they
don't have any competition for dozens of years to come," said Jake
Hansen, an executive at generic drug maker Barr Pharmaceuticals Inc.

The biotech-generic squabbling is in the hands of lawmakers, who set
their own schedules.

Senate lawmakers drafted a bill aimed at bridging the divide last year,
but they were unable to bring it to a final vote. Lawmakers on the House
side have made even less progress.

A spokeswoman for Democratic Rep. John Dingell, who chairs the committee
that oversees FDA, said he is interested in tackling generic biotech,
but has no timetable for legislation. No hearings on the issue have been
scheduled in the House.


2.
http://www.chicagotribune.com/features/lifestyle/health/chi-thu_notebook_02=
14feb14,1,7795556.story
INSIDE HEALTH CARE
Bush plan would allow generic biotech drugs
BY BRUCE JAPSEN
February 14, 2008

The Bush administration, perceived as on the sidelines in the building
movement in Congress for regulations that would allow cheaper medicines
derived from biotechnology, has -- for the first time -- included a
proposal for "generic biologics" in its policy agenda.

Such legislation in the administration's fiscal 2009 budget would allow
competition from generic versions of biotech drugs. Such a move would
open the door to prescription innovations for cancer, anemia and other
treatments that are derived from human or animal cells and can cost tens
of thousands of dollars a year.

In the absence of such legislation, biotech companies would enjoy longer
patent protection because there is no regulatory pathway within the Food
and Drug Administration to bring generic versions of biotech drugs,
known as biogenerics or biosimilars, to market.

Secretary of Health and Human Services Mike Leavitt told the Senate
Finance Committee last week that he believed "follow-on biologics are an
important medical development. We'd like to see them expanded in their
generic form like we would all generics."

Biotech drugs were not part of the landmark 1984 Hatch-Waxman law that
allowed for cheaper generics. That law largely covers products derived
from chemicals, such as the cholesterol drugs Zocor and Lipitor and the
popular antidepressant Zoloft. Many biotechnology drugs, first created
in the 1980s when technology cleared the way for genetic engineering on
DNA, are only now beginning to face patent expirations.

At stake are huge potential savings for consumers. Take the anti-anemia
drug Epogen, which can cost more than $10,000 a year per patient. Other
biotech treatments for cancer and rheumatoid arthritis can cost more.

Given this is an election year, key Democrats and Republicans in the
House and Senate are pushing for votes and a bill that some say could
reach President Bush's desk later this year. And drug companies that
want to make generic biotech drugs, such as Lake Forest-based Hospira
Inc., are lobbying fiercely for legislation that they think has a good
chance at passing this year.

"Patients need an approval pathway that provides them with access to
safe and effective biogenerics sooner rather than later," said Kathleen
Jaeger, president and chief executive of the Generic Pharmaceutical
Association. "A pathway filled with roadblocks to access, including
excessive market exclusivity provisions, is an empty promise for
countless patients who need these affordable life-saving medicines."

The makers of brand-name biotech drugs such as Johnson & Johnson and
Amgen Inc. are proceeding with caution, pushing for clinical trials and
other scrutiny before biogenerics are allowed to reach the U.S. market.

----------
3. Coalition for a Competitive Pharmaceutical Market Launches New Print
Ad Campaign Highlighting Need for Meaningful Biogenerics Legislation
Posted : Thu, 14 Feb 2008 20:10:23 GMT
Author : CCPM
Category : PressRelease


WASHINGTON, Feb. 14 /PRNewswire-USNewswire/ -- As part of its campaign
to enact meaningful biogenerics legislation that would create a pathway
for FDA approval of safe and effective biogenerics, CCPM unveiled a new
print advertisement that features a footprint in the snow stating:
"Don't Leave Patients Out in the Cold."

The ad highlights how meaningful biogenerics legislation should be
balanced to foster innovation without excessive and unprecedented market
exclusivity that simply extends brand monopolies. Such legislation would
be an empty promise for patients.

In addition, CCPM released letters to the Administration and to the
House Energy & Commerce Committee Leadership stressing the need for
biologics legislation that provides a meaningful FDA pathway and not a
pathway in name only.

CCPM supports public policies that facilitate timely access to
affordable pharmaceuticals. Visit http://www.competitiverx.com/ for more
information and a list of CCPM members.

Contact: Katie Braden Huffard, 202-255-5216;

Andrea Hofelich, 703-647-2495; Charles Cote, 202-207-3605



--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/