Biotechnology Industry Organization

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BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,200 members worldwide. Our mission is to be the champion of biotechnology and the advocate for our member organizations—both large and small.

bulletNews and Items of Interest

Eshoo Borrows From HELP Bill In Challenge To Waxman On Biologics

Jul 16, 2009 - Inside Health Policy

House Democrats unveiled a health reform bill Tuesday (July 14) without so much as a placeholder on generic biologics -- a strategy that lobbyists expected Energy and Commerce Committee Chair Henry Waxman to pursue, but for which he is facing increasing resistance as the House moves closer to a markup. Rep. Anna Eshoo may be throwing up yet another roadblock for Waxman as she sets aside much of her own biosimilars bill and focuses instead on a bipartisan Senate measure.

Earlier, Eshoo (D-CA) had threatened to introduce her bill, which the brand-name drug industry strongly supports, as an amendment during the health reform markup unless she and Waxman could reach an agreement beforehand. Instead, she now plans to introduce a biologics provision based on what the Senate Health, Education, Labor and Pensions Committee approved as part of its reform bill.

Eshoo's legislation would award innovator biologics 14 years of data exclusivity; Waxman (D-CA) only wants to give them five to seven years. The HELP provision includes a 12-year exclusivity period. But it is much better for generics on pathway issues such as interchangeability and clinical-trial requirements. On those issues, the HELP pathway is more in line with Waxman's bill than Eshoo's.

The Eshoo bill would, for example, require FDA to write class-specific guidances before approving follow-on biologics and prohibit the agency from stating that a biosimilar is interchangeable with its reference product. It would also require follow-on applicants to submit clinical trial data to FDA.

The HELP bill, on the other hand, would let FDA make interchangeability decisions. It includes minimum criteria for any guidances the agency might choose to publish, but it does not make the documents a prerequisite to approval. And though it includes a provision requiring follow-on manufacturers to submit clinical data in their applications, FDA would be able to waive that requirement.

The HELP Committee's support for the 12-year proposal was strong -- the panel voted 16-7 to include it in health care reform, and a competing proposal with seven years failed by a 5-17 vote. Lobbyists were surprised by the outcome and speculated that Waxman was also expecting the Senate to include something less than 12 years. Those lopsided votes, combined with the fact that Eshoo has more than 130 cosponsors for an even more brand-friendly proposal, make her position seem strong.

An Eshoo aide told FDA Week, however, that her amendment won't simply be the entire Senate policy. Eshoo will retain the controversial patent provisions from her legislation, the aide said. Lobbyists and sources following the debate said her hand would be stronger if she took up the whole HELP bill. The patent provisions still give critics an opening, they noted, and the brand-name industry would have little room to fault her for a reversal on pathway issues. The Biotechnology Industry Organization proclaimed victory after the Senate panel's Monday evening vote.

It's still possible that the 12 years won't make it out of the Senate: AARP opposes the provision, Sen. Christopher Dodd (D-CT) indicated the provision might be revised, and Sen. Sherrod Brown (D-OH) vowed to keep the issue alive on the floor.

The White House recently lent Waxman its support (see FDA Week, July 3), but Eshoo continues to push for more exclusivity. She testified before another committee about her bill Tuesday (see related story) and scheduled several public events recently to make her case.

Furthermore, the New Democrat Coalition has endorsed her bill and urged House leadership this week to add it to the reform package. "An express endorsement by the House is necessary to demonstrate support for the underlying policy prior to conference negotiations," the coalition states in a letter. "We are concerned that without a clear position from the House, the final product from the conference committee could reduce the period of data protection under the legislation and upset the balance of procedures for both innovators and generics that will lead to timely resolution of patent disputes."

The outcome that the New Democrats fear might be exactly what Waxman wants. Lobbyists believe he would prefer not to include any follow-on biologics proposal, even his own, in the reform bill prior to conference. Waxman would rather knock down the Senate's exclusivity period in conference, the lobbyists believe, which would avoid the risks of compromising with (or losing to) Eshoo. -- Sam Baker (sbaker@iwpnews.com)

Date: July 16, 2009

© Inside Washington Publishers

7162009_borrows

Click here to view BIO's letter of support for the Eshoo amendment.

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What’s going on with the biotechnology public awareness campaign?

The biotechnology public awareness campaign is a new initiative to inform people about biotechnology and how it impacts their daily lives. Our hope is to find common ground and build a strong community of people who are interested in protecting progress in areas such as finding cures for debilitating diseases, enhancing sustainable agriculture and developing clean, renewable fuels that help combat global warming. We are at our strongest when we work together.

We have built interactive websites to provide people with a place to come together, learn from one another and speak their minds.

We hope you will use both of these sites as an opportunity to share the great work you are doing and add your perspective to the discussion. Please contribute as often as you like... once a month, or even once a week!

Want your organization to be part of a charitable giving program? We are working to launch a new feature on IAmBiotech.org. Currently, when people contribute content to IAmBiotech.org, we send them a $25 gift card as a small incentive. We would like to provide people with the opportunity to donate that $25 to the charitable organization of their choice. If you would like your organization to be considered as one of our select biotech charitable organizations, please send an email to team@iambiotech.org .

Finally, don’t forget about the first-ever Biotech Humanitarian of the Year Award. Nominations close on April 15th! The $10K award will go to an outstanding innovator in the field of biotechnology who has enhanced the human experience by harnessing the power of biotechnology to heal, feed or fuel the planet. Please take 5 minutes to submit a very simple online nomination and be sure to pass the information along. This is a great opportunity to highlight the work of someone in your community or someone who has made an impact on your issue.

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bulletLetters supported by ICAN

October 19, 2009

The Honorable Harry Reid                                           
Majority Leader                                                     
United States Senate                                                   
Washington, DC 20510                                              

The Honorable Mitch McConnell 
Republican Leader 
United States Senate 
Washington, DC 20510

The Honorable Nancy Pelosi                                     
Speaker                                                                      
United States House of Representatives                   
Washington, DC 20515    

The Honorable John Boehner 
Republican Leader    
United States House of Representatives                                          
Washington, DC 20515

Dear Majority Leader Reid, Republican Leader McConnell, Speaker Pelosi, and Republican Leader Boehner:

As representatives from the patient and health advocacy community, we are writing to ask for your support of the Therapeutic Discovery Project Tax Credit which was included as part of the Senate Finance Committee-passed healthcare reform package. This tax credit encourages investment in new promising therapies to prevent, diagnose, and treat acute and chronic diseases.

Many emerging biotechnology companies are poised to make great advances in the treatment of diseases like cancer, diabetes, heart disease, autoimmune diseases, Muscular Dystrophy, Parkinson’s disease, Multiple Sclerosis, Alzheimer’s disease, cystic fibrosis and countless un- or undertreated diseases. However, America’s research and capital-intensive small companies involved in the development of next-generation technologies are struggling to raise the necessary capital to survive the current financial crisis. This is especially the case regarding the U.S. biotechnology industry.

The Therapeutic Discovery Project Tax Credit would inject much-needed capital into small, research-intensive companies struggling to survive a devastating capital shortfall. Following the tax precedent recently set for alternative energy companies [IRC §48C], companies with 250 employees or fewer could apply for the tax credit up to 50 percent of qualified expenses associated with the research and development of new promising therapies designed to treat or prevent diseases and conditions in tax years 2009 and 2010. These funds would sustain research into new therapies by funding activities such as hiring researchers and scientists and conducting clinical studies, investments that could not otherwise be sustained given the current investment climate.

We believe that small life sciences companies are a key component of the intellectual infrastructure of America’s 21st century economy. As U.S. healthcare costs continue to rise, the biotechnology industry will play a critical role in reducing future spending and improving quality of life for patients. A number of our patient-focused nonprofit organizations fund medical research in academia and industry, and rely on these companies to shepherd, from bench-to–bedside, new and life saving therapies for patients across the country.

We strongly urge you to support the Therapeutic Discovery Project Tax Credit during consideration of healthcare reform.

Sincerely,

Alliance for Aging Research
Allied Diseases Association
Alpha-1 Foundation ALS Association
ALS Therapy Development Institute
Alzheimer's Drug Discovery Foundation
American Association for Cancer Research
American Autoimmune Related Diseases Association
CADASIL Together We Have Hope
Californians for Cures
CANN - Community Access National Network
Celiac Disease Center at Columbia University
Centronuclear Myopathy Project
Children's Tumor Foundation
Cure Duchenne
Dystonia Medical Research Foundation
Easter Seals
Epilepsy Therapy Project
Foundation Fighting Blindness, Inc.
Friedreich’s Ataxia Research Alliance
Genetic Alliance
HealthCare Institute of New Jersey
In Need Of Diagnosis, Inc.
International Cancer Advocacy Network (ICAN)
International Foundation for Gastrointestinal Disorders
Interstitial Cystitis Association
Kidney Cancer Association
Leukemia & Lymphoma Society
Myotubular Myopathy Resource Group
National Hispanic Medical Association
National Multiple Sclerosis Society
National Tay-Sachs
Parent Project Muscular Dystrophy
Parkinson's Action Network
PXE International
Society for Women's Health Research
Spinal Muscular Atrophy Foundation
Student Society for Stem Cell Research
Sturge-Weber Foundation
The Life Raft Group
Tuberous Sclerosis Alliance

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June 23, 2009

The Honorable Edward M. Kennedy
Chairman, Committee on Health,
Education, Labor and Pensions
317 Russell Senate Building
Washington, DC 20510

The Honorable Michael B. Enzi
Ranking Member, Committee on Health,
Education, Labor and Pensions
379A Russell Senate Building
Washington, DC 20510

On behalf of patients, physicians, researchers, and other stakeholders in the medical research enterprise, we commend your efforts to enact true health reform, and we support your commitment to include a regulatory pathway for follow-on biologics, or biosimilars, in the Committee's healthcare reform legislation. We appreciate the difficult balance you are trying to establish between the need to reduce costs and increase access to biologic therapies while also advancing patient safety and incentives for the development of new life-saving biologics.

We jointly express our support for the inclusion of the Biologics Price Competition and Innovation Act of 2007, S. 1695, the compromise legislation reported by the Health, Education, Labor and Pensions (HELP) Committee in the 110th Congress, in the Affordable Health Choices Act, and oppose replacing that language with the Promoting Innovation and Access to Life-Saving Medicine Act, S. 726. While we understand additional modifications will be needed before passage, including the addition of pediatric incentives, we urge the Committee to respect the carefully crafted balance between access, patient safety, and future medical breakthroughs inherent in S. 1695.

Thank you again for your leadership and we look forward to working with you on this important legislation.

Sincerely,

Acorda Therapeutics, Inc.
Affiliated American CSA Foundation
Affymax Inc.
Alamo Breast Cancer Foundation
Alliance for Aging Research Alliance for Patient
Access Allograft Research Technologies
American Association of Orthopaedic Surgeons
American Autoimmune Related Diseases Association
Arizona BioIndustry Association
Association of American Universities
Association of University Technology Managers
Autism Society of Colorado
Azaya Therapeutics, Inc.
BayBio
BIO Austin
BIOCOM
BioFlorida
BioForward
BioHouston
BioMed SA
BioMed San Antonio
BioNJ
BioOhio
Biotechnology Association of Maine
BostonBio Com, LLC
Brooklyn Chamber of Commerce
California Healthcare Institute
Californians For Cures
Cambridge Chamber of Commerce
Celiac Disease Center at Columbia University
Ceregene, Inc.
Children’s Neurobiological Solutions
Children's Tumor Foundation
Colon Cancer Alliance
Colorado BioScience Association
CombinatoRx, Incorporated
Conatus Pharmaceuticals Inc.
Craig Hospital for Brain and Spinal Cord Injury
CURE, The Center of Connecticut's BioScience Cluster
Cutaneous Lymphoma Foundation
Dan Onorato, Allegheny County Executive
Delaware BioScience Association
Development Corporation of Abilene
Dr. Bruce Holm, New York State Center of Excellence in Bioinformatics & Life Sciences
Dr. Charles Sanders, Former CEO & Chair of Glaxo, Inc. Former General Director of Massachusetts General Hospital and professor of medicine at Harvard School of Medicine
Dr. Jordan Cohen, Vice President for Research, University of Iowa
Dr. Richard Dean, President Emeritus, Wake Forest University Health Sciences and former CEO, Wake Forest University Baptist Medical Center
Dr. Suresh Sidh, Chesapeake Urology Associates
East River Science Park
Erickson Retirement Communities
Fitzsimons Redevelopment Authority
Frank DiCicco, Philadelphia City Councilman
Frank Dinucci, President and CEO BostonBioCom, LLC
GenVec, Inc
Georgia Bio
Geron Corporation
GlycoMimetics, Inc
Greater Baltimore Committee
Gregory M. Weinhoff, MD., CHL Medical Partners
Hawaii Science & Technology Council
Hershey Center for Applied Research
Hydra Biosciences
Illinois Biotechnology Industry Organization (iBIO®)
ImaRx Therapeutics, Inc.
In Toone Communications
Indiana Health Industry Forum
INDUNIV Research Consortium / BioAlliance Puerto Rico
Infabloc Pharmaceuticals
Inspire Pharmaceuticals, Inc.
Institute for African American Health
Integrated DNA Technologies
International Cancer Advocacy Network
inVentiv Clinical Solutions, LLC.
Iowa Biotechnology Association
Iowa State Senator Amanda Ragan, Assistant Majority Leader
Iowa State Senator Matt McCoy
Johns Hopkins Institutions
KansasBio
Kemin Nutrisurance, Inc
Len Fruchter, Fruchter Rosen & Company
Life Sciences Greenhouse of Central Pennsylvania
LifeScience Alley
Luis Miranda, Former Chair, New York City Health & Hospitals Association
Lupus Foundation of Mid and Northern New York
Manzanita Pharmaceuticals, Inc.
Massachusetts Biomedical Initiatives
Massachusetts Biotechnology Council
Massachusetts Society of Optometrists
Max Formal Company
Mayor Scott Padgett, Concord, NC
Mayor William V. Bell, Durham, NC
MDA Venture Philanthropy
MdBio Division of the Tech Council of Maryland
Men's Health Network
Merrimack Valley Economic Development Council, Inc.
Metabolex, Inc.
MichBio Mid-Atlantic LifeSpan
Missouri Biotechnology Association
Montana BioScience Alliance
National Alliance for Caregiving
National Alliance on Mental Illness
National Alopecia Areata Foundation
National Kidney Foundation
National Venture Capital Association
Neurotech
New England Biotech Association
New York Biotechnology Association
North Carolina Biosciences Organization
Northern Rhode Island Chamber of Commerce
OncoMed Pharmaceuticals
Parent Project Muscular Dystrophy
Pennsylvania Bio
Peptimmune, Inc.
Peter Feld, Public Health Research
Pharmaceutical Services Corporation
Polaris Venture Partners
PTV Sciences
Q Therapeutics
Queens Chamber of Commerce
Research for Cure
RetireSafe
Rhode Island BIOGroup
Rhode Island State Nurses Association
Sage Management Group
San Antonio Chamber
Shire
South Dakota Biotech Association
South Shore Chamber of Commerce
Southern California Biomedical Council
State Representative John Sabatina, Jr., Pennsylvania
State Representative Rick Taylor, Pennsylvania
State Representative Scott Petri, Pennsylvania
State Representative Tim Briggs, Pennsylvania
State Representative Tony Payton, Jr., Pennsylvania
Symphony Capital LLC
Tennessee Biotechnology Association
Terapio Inc.
Texas Healthcare and Bioscience Institute
Texas Life-sciences Collaboration Center
Texas Research and Technology Foundation
The AIDS Institute
The ALS Association
The Greater Raleigh Chamber of Commerce
The Research Triangle Regional Partnership
The Sjögren’s Syndrome Foundation
The Sturge-Weber Foundation
The University of North Carolina Trevena Inc.
University City Science Center
Urban Sun Investments
Utah Technology Council
Vietnam Veterans of America
Vilano Associates
Virginia Biotechnology Association
Vital Options International
vSpring Capital
Wake County Economic Development
Washington Biotechnology & Biomedical Association
Wisconsin Alumni Research Foundation
Worcester Regional Chamber of Commerce

cc: Committee on Health, Education, Labor and Pensions

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June 9, 2009

The Honorable Edward M. Kennedy
Chairman, Committee on Health,
Education, Labor and Pensions
317 Russell Senate Building
Washington, DC 20510

The Honorable Michael B. Enzi
Ranking Member, Committee on Health,
Education, Labor and Pensions
379A Russell Senate Building
Washington, DC 20510


Dear Chairman Kennedy and Ranking Member Enzi:

As leaders in the patient advocacy community, we applaud your commitment to facilitating access to new and life-saving therapies and offer our strong support for the creation of a regulatory pathway for follow-on biologics, or biosimilars. We appreciate the difficult balance you are trying to establish between the need to reduce costs and increase access to biologic therapies while also advancing patient safety and incentives for the development of new life-saving biologics. We believe your legislation in the 110th Congress, the Biologics Price Competition and Innovation Act of 2007, S. 1695, went a long way toward identifying the appropriate balance.

We support the inclusion of a balanced regulatory pathway within the larger healthcare reform effort. It is our understanding, however, that there has been discussion to greatly expand the first-licensure provision, precluding new exclusivity periods for products that differ significantly from original products. Under S. 1695, the first licensure provision protected against "evergreening" while preserving incentives to develop new and improved products in the same pharmacological class. However, the new first licensure language would go well beyond that. As an example, with this new language data exclusivity periods could be denied to later-generation anti-TNF drugs, reducing incentives to develop therapeutic alternatives that have proved beneficial for patients with conditions such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

As health advocacy organizations, we place a high value on new and next-generation products. We believe the existing provision in S. 1695 adequately prevents evergreening by precluding a new period of data exclusivity based on approval of a supplement to the biologics license application (BLA) for the original product or a separate BLA for a new indication, route of administration, dosage form, or strength for the previously licensed reference product.

The medical research enterprise is poised to make great advancements and improve the lives of people living with cancer, diabetes, heart disease, lupus, Parkinson’s disease, and countless other conditions. We believe continued innovative research offers the best hope for treating and ideally curing life-threatening and disabling disorders.
Just as you are working to strike a balance, we too are concerned with ensuring both the development of breakthrough therapies and improvements to them, as well as access to such treatments for patients who are in critical need. We therefore urge you to not add to the legislation a new first licensure provision that would disincentivize the development of next-generation products.

Thank you again for your leadership and we look forward to working with you on this important legislation.

Sincerely,

Affiliated American Celiac Sprue Association Foundation, Inc
Alliance for Aging Research
Alliance for Patient Access
American Association of Orthopaedic Surgeons
American Institute for Medical and Biological Engineering
Association of Black Cardiologists
Californians for Cures
Candlelighters Childhood Cancer Foundation
Celiac Disease Center at Columbia University
Children's Tumor Foundation
Colon Cancer Alliance
Community Health Charities of America
Easter Seals
Epilepsy Therapy Project
International Cancer Advocacy Network
Kidney Cancer Association
Men's Health Network
National Alliance of State Prostate Cancer Coalitions
National Alopecia Areata Foundation
National Eczema Association
National Foundation for Ectodermal Dysplasias
National Kidney Foundation
NBIA Disorders Association
Parent Project Muscular Dystrophy
Research for Cure
RetireSafe

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March 25, 2009

The Honorable Patrick Leahy
United States Senate
Washington, DC 20510

Dear Chairman Leahy:

We the undersigned organizations represent patients, families, physicians and communities addressing devastating diseases and urgent health care needs. It is our understanding that your Committee is undertaking major legislative reform of the current patent laws that will have a direct impact on the development of new diagnostics, therapeutics and treatments for those we represent.

Our message is simple – whatever you do, you must protect the development of these products in order to improve and hopefully save the lives of hundreds of thousands of Americans.

We know the pipeline for new products starts with the research and patents from universities and small companies. Without patents, most innovative ideas would be just that – ideas. Patents are the drivers of investment which turn these ideas into products. Whether a company licenses patents from a university, or develops its own, the value of the patents is what allows them to attract funding, especially in the early stages.

If a patent's value can be diminished, or a patent can be challenged on a broad range of grounds, at any time during the long process of product development – or even if a patent can be perceived to be weak and at risk the closer the research gets to a product – we know investors will back away. With small companies accounting for two-thirds of the future clinical pipeline, we know you will share our concern that patent reform does not have the unintended consequence of drying up a huge portion of potential products and our greatest hope for better treatments and interventions.

Frankly there are enormous risks in diagnostic and therapeutic developments now that make it an uncertain investment. Increasingly nonprofit organizations are trying to find ways to drive more money into the early stages of translational research, proof of concept and even the earliest phases of clinical trials.

Your committee is moving quickly on major patent reforms. You are clearly trying to address important public policy issues. We appreciate your efforts and hope that you hear our voices as you deliberate and ensure that whatever actions you undertake do not unduly undermine the development of the life-saving products we so desperately in need.

Sincerely,

AA CSA Foundation
Alliance for Aging Research
Alpha-1 Foundation
American Association for Respiratory Care
American Autoimmune Related Diseases
Association Association of Jewish Aging Services of North America
CANN - Community Access National Network
Celiac Disease Center at Columbia University
Children's Cause for Cancer Advocacy
Children's Tumor Foundation
Colon Cancer Alliance
Community Health Charities of America
Cornell University
Cystic Fibrosis Foundation
Foundation for Sarcoidosis Research
International Cancer Advocacy Network (ICAN)
Kidney Cancer Association
Men's Health Network
Muscular Dystrophy Association
National Alopecia Areata Foundation
National Spinal Cord Injury Association
Parkinson's Action Network
RetireSafe
SAVE (Suicide Awareness Voices of Education)
Spina Bifida Association
Stony Brook University
The ALS Association
The Alzheimer's Drug Discovery Foundation
University at Buffalo
Vital Options International

cc: The Honorable Arlen Specter
Members, United State Senate Committee on the Judiciary

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