[Ip-health] New Bill in Congress calls for 14 years of Data Exclusivity

[Maria F Jorge]

Dear all, it is clear that BIO considers that they will have a more friendly
congress in 2008 than next year and they are pushing very hard to define the
legal pathway in 2008.
We understand that Members of the Energy and Commerce Committee have just
received an email from Reps. Barton/Eshoo asking them to be cosponsors to
their bill they will be introducing.  It seems that the bill grants 14 years
of market exclusivity (12 yrs plus 2 yrs for a new indication approved post
approval).  Furthermore, we were told that it is replete with regulatory and
patent barriers.  We should think on how to put pressure to stop this
nonsense of additional years of data exclusivity.  Perhaps we should start
by calling/emailing all the Members of the Commerce Committee and the Health
Subcommittee to ask them to oppose such bill.
Regards,
M Fabiana

-----Original Message-----
From: ip-health-admin@lists.essential.org
[mailto:ip-health-admin@lists.essential.org] On Behalf Of Sarah Rimmington
Sent: Thursday, February 14, 2008 11:40 PM
To: Ip-health@lists.essential.org
Subject: [Ip-health] Bloomberg: Generics Capture 65% of U.S. Market as Costs
Rise

Note the discussion of a regulatory pathway for biogenerics at the
bottom, as well as the positions of the leading presidential candidates
on the issue of biogenerics legislation.


Generics Capture 65% of U.S. Market as Costs Rise (Update1)

By Catherine Larkin

Feb. 12 (Bloomberg) -- Two-thirds of prescriptions filled in the U.S.,
the most ever, are cheap copies of brand names made by generic-drug
companies.

Generics accounted for 65 percent of the U.S. market last year, up from
63 percent in 2006, according to data released today at the Generic
Pharmaceutical Association's annual industry meeting in Boca Raton,
Florida. Costlier brand-name drugs made up about 80 percent of dollars
spent on prescriptions in each year.

The figures, compiled by the research firm IMS Health Inc., show generic
drugmakers are capitalizing on expiring patents and efforts by insurers
to rein in health-care costs. The companies seek further gains this year
as drugs with $20 billion in annual sales lose patent protection and the
presidential candidates promise to make generic drugs more widely available.

``We're poised to do very well,'' said Kathleen Jaeger, president of the
Arlington, Virginia-based Generic Pharmaceutical Association, in an
interview yesterday. ``All the candidates believe that generics are part
of the answer.''

Drugs facing generic competition for the first time this year include
Merck & Co.'s osteoporosis treatment Fosamax and Johnson & Johnson's
antipsychotic therapy Risperdal. Generic-drug companies are permitted
under a 1984 U.S. law to apply for approval to copy conventional
medicines, made through chemical synthesis, once patents expire or are
ruled invalid.

Executives from the world's biggest sellers of generic drugs --
including Israel's Teva Pharmaceutical Industries Ltd., the Sandoz unit
of Swiss drugmaker Novartis AG, and U.S.-based Mylan Inc. -- gather each
year to discuss strategies for success in the competitive, low-margin
business.

Health-Care Overhaul

This year's topics include proposals by presidential candidates and
lawmakers to overhaul the U.S. health-care system and to create a
pathway for copies of medicines made through biotechnology. Costs for
medical services have risen faster than wages and White House hopefuls
from both parties have vowed to slow health-care inflation.

Paul Bisaro, chief executive officer of Watson Pharmaceuticals Inc.,
said changes in health-care policy may not benefit his company and other
generic drugmakers unless they play an active role to ensure the new
rules aren't manipulated by brand-name companies with more lobbying
power in Washington.

``We have to be careful with health-care reform,'' Bisaro of Corona,
California-based Watson said yesterday in an interview. ``Well-meaning,
well-intentioned efforts could be very damaging to our industry.''

Democratic presidential candidate Hillary Clinton co- sponsored
legislation last year that would for the first time allow the U.S. Food
and Drug Administration to approve copies of biotechnology drugs that
have been on the market at least 12 years.

Delayed Competition

Generic companies have called for revisions to the proposal, saying 12
years is too long to delay competition for drugs that can cost as much
as $200,000 a year. Americans now spend $40 billion annually on
medicines made from living cells, including Amgen Inc.'s anemia
treatment Epogen.

Generic drugmakers also want the FDA to be able to consider on a
case-by-case basis when clinical trials are needed to approve a copy of
a biotechnology drug and when the copy can be substituted for the brand
product at a pharmacy.

``We must achieve a balance of affordability, access and innovation,''
said Senator Charles Schumer, a New York Democrat and longtime advocate
of generics, in a taped speech today at the industry conference. ``We
need a clean approval pathway that is driven by science and allows FDA
discretion based on that science.''

Presidential Candidates

Clinton, a New York senator, has said that if elected president she
would increase funding for the FDA's Office of Generic Drugs to speed
reviews of new medicines and eliminate ``loopholes'' in U.S. law that
allow brand-name companies to block generic products from entering the
market.

Generic companies say they don't want to start paying regulators to
handle their drug applications, as proposed by President George W. Bush
this month in his budget, unless quicker reviews are guaranteed.

Clinton's Democratic rival Barack Obama, a senator from Illinois, has
said he also would prevent brand-name companies from blocking copies and
would encourage wider use of generics in U.S. health programs, including
Medicare for the elderly and Medicaid for the poor, to lower costs.

Obama and Senator John McCain of Arizona, the leading Republican
candidate for president, want to allow Americans to buy drugs from
Canada and other countries if the medicines are shown to be safe and
less expensive. McCain also has said he wants to improve the approval
process for generic drugs and biotechnology medicines.

To contact the reporter on this story: Catherine Larkin in Boca Raton,
Florida, at clarkin4@bloomberg.net .

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

_______________________________________________
Ip-health mailing list
Ip-health@lists.essential.org
http://lists.essential.org/mailman/listinfo/ip-health