[Ip-health] New Bill in Congress calls for 14 years of Data Exclusivity
Maria F Jorge
mfjorge@mfjint.com
Mon Feb 25 14:00:02 2008
Hi to all, here are the relevant email addresses. Thank you!
Dolores and M Fabiana
Health Subcommittee, Committee on Energy and Commerce:
DEMOCRATS
Bart Gordon: Legislative Director: david.plunkett@mail.house.gov
Leg. Assistant (health):
dana.lichtenberg@mail.house.gov
Diana DeGette: degette@mail.house.gov
Leg Assistant (health
Care):jed.perry@mail.house.gov
Leg. Director:
Shannon.good@mail.house.gov
Lois Capps: Leg.Assistant (Health): amy.fisher@mail.house.gov
Eliot Engel: Leg.Director (health): Emily.gibbons@mail.house.gov
Jan Schakowsky: Chief of Staff: cathy.hurvit@mail.house.gov
Hilda Solis solis@mail.house.gov
Leg. Director: megan.uzzell@mail.house.gov
Mike Ross: mike.ross@mail.house.gov
Chief of staff: drew.goesl@mail.house.gov
Anthony Weiner: weiner@mail.house.gov
Leg. Director: armen.meyer@mail.house.gov
Jim Matheson: jim.matheson@mail.house.gov
Leg.Director (health):
neeta.bidwai@mail.house.gov
John Dingell: Leg. Director: Joshua.tzuker@mail.house.gov
REPUBLICANS:
Nathan Deal: Senior Legislative Assistant (Energy & Commerce Com.):
ellis.chaplin@mail.house.gov
Ralph Hall: rmhall@mail.house.gov
Leg. Director (health):
amy.dyer@mail.house.gov
Barbara Cubin: Senior Leg. Assistant (health):
landon.stropko@mail.house.gov
Heather Wilson: ask.heather@mail.house.gov
Legislative Director Joe Moser
John Shadegg: Leg Assistant (health): shaun.small@mail.house.gov
Steve Buyer: Leg. Director: laura.zuckerman@mail.house.gov
Joseph Pitts: pitts.pa16@mail.house.gov
Leg. Director: Monica.volante@mail.house.gov
Mike Ferguson: Senior Leg. Assistant (Energy & Commerce):
tom.fussaro@mail.house.gov
Mike Rogers: Leg Director: chris.brinson@mail.house.gov
Sue Myrick: myrick@mail.house.gov
Leg. Director (health):
sarah.hale@mail.house.gov
John Sullivan: Leg Director: john.rainbolt@mail.house.gov
Tim Murphy: Leg. Director (health): Michael.baxter@mail.house.gov
Michael Burgess: Leg. Director (health): josh.martin@mail.house.gov
Marsha Blackburn: Policy Director: greg.louer@mail.house.gov
-----Original Message-----
From: Jeffrey A. Williams [mailto:jwkckid1@ix.netcom.com]
Sent: Friday, February 15, 2008 8:16 PM
To: Maria F Jorge
Cc: 'Sarah Rimmington'; Ip-health@lists.essential.org
Subject: Re: [Ip-health] New Bill in Congress calls for 14 years of Data
Exclusivity
Maria and all,
A good idea you have! Post the relevant Email addresses
and I shall forward them to all of our members suggesting they
express their sentiments.
Personally speaking, I don't believe this bill has a chance in
hell of getting out of committee regardless... I suspect none
of our members will be in favor of it...
Regards,
Spokesman for INEGroup LLA. - (Over 277k members/stakeholders strong!)
"Obedience of the law is the greatest freedom" -
Abraham Lincoln
"Credit should go with the performance of duty and not with what is
very often the accident of glory" - Theodore Roosevelt
"If the probability be called P; the injury, L; and the burden, B;
liability depends upon whether B is less than L multiplied by
P: i.e., whether B is less than PL."
United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947]
===============================================================
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My Phone: 214-244-4827
Maria F Jorge wrote:
> 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/
>
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