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HHS Drug Importation Plan a "Misguided Attempt to Keep an Ill-Informed Campaign Promise"
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Cost & Value of Biopharmaceuticals  •  Press Release  •  July 31, 2019
Following the introduction of the Trump administration’s drug importation proposal, BIO’s President and CEO Jim Greenwood issued the following statement: “There is simply no way to adopt an importation scheme that doesn’t jeopardize the health and well-being of America’s patients. That’s been the judgment of past FDA commissioners who served under both Republican and Democratic administrations. Not only will this undermine the safety of our nation’s drug supply, but nonpartisan budget experts have said that the costs of implementing drug importation will largely outweigh any savings the Administration may hope to achieve. This is a misguided attempt to keep a ill-informed campaign promise. The burden is on the leadership of the Department of Health and Human Services to ensure this actually leads to lower costs for consumers—not just for insurance companies and pharmacy benefit managers—and no harm is inflicted on patients and local communities.”
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The Partnership of Publicly Research & Private Innovation
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Human Health, Biotech Basics  •  Toolkit  •  July 31, 2019
Private entities take foundational knowledge from public research and invent practical applications that result in real-life treatments and cures for patients.
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Congressional Letter to FDA Commissioner Sharpless on Animal Biotech
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Agriculture & Environment, Food & Farm Innovation  •  Letters, Testimony & Comments  •  July 26, 2019
In recent years advances in animal genetics have provided significant breakthroughs that can help to address some of society's most difficult challenges. These technologies can treat and protect animals from illness; limit the transmission of dangerous diseases, like African swine fever or avian influenza; curb the use of antibiotics in agriculture; address hunger and insect-borne disease in developing nations; improve animal welfare; among many other benefits.  ... While we think a robust conversation should be had on the best way to provide transparency to consumers and users on the nature of these animals, that discussion will be moot if our nation's regulatory system prevents these animals from coming to market. We again urge you to work with other relevant agencies and stakeholder communities to develop a more appropriate, workable approach that will provide sufficient safeguards, while allowing U.S. farmers, consumers, and the public health officials access to animal innovations. 
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Increased Investment in Research for Debilitating Diseases is Focus of Newly Introduced Bill in Congress Today
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Human Health  •  Press Release  •  July 23, 2019
Washington, DC (July 23, 2019) – Today, legislation that would significantly improve the ability of emerging biotechnology companies to focus their investor capital on science and biomedical innovation was introduced in the House of Representatives by Reps. Trey Hollingsworth (R-IN) and Ben McAdams (D-UT). The Fostering Innovation Act extends one vital JOBS Act provision – the temporary exemption from Section 404(b) of Sarbanes-Oxley (SOX) – for an additional five years for qualifying pre-revenue small businesses. “For emerging biotech companies, one-size-fits-all compliance burdens present a costly roadblock to growth and medical progress,” said Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood. “These companies typically operate for many years without product revenue, meaning that funds needed to comply with unduly burdensome regulations are diverted from their intended purpose – scientific advancement for the benefit of patients and consumers. The Fostering Innovation Act would reduce the cost of Sarbanes-Oxley compliance for these companies – without undermining important investor protections – allowing them to utilize investment capital to spur job creation and advance their potentially life-saving research. This will allow companies to focus their capital on treatments for dozens of devastating diseases such as cancer, HIV/AIDS, Sickle cell disease, and many others.” “Congressmen Hollingsworth and McAdams have put the interests of patients and medical progress first with their bipartisan leadership on this important legislation, passage of which has long been a major advocacy priority for BIO and our emerging growth member companies.”
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Senate Finance Drug Pricing Proposal Misses the Mark
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Human Health, Cost & Value of Biopharmaceuticals  •  Press Release  •  July 23, 2019
Washington, DC (July 23, 2019) – Following the release of the Senate Finance Committee’s drug pricing proposal, Tom DiLenge, the Biotechnology Innovation Organization’s President of Advocacy, Law & Public Policy Division issued the following statement: “While we’re pleased that the Senate Finance Committee proposal caps what beneficiaries have to pay out of pocket for medicines under Medicare Part D, it adopts a framework that punishes some of the most innovative biotech cures and transformative therapies.  “The proposal does almost nothing to hold insurance companies and middlemen accountable for shifting more of the cost burden onto patients. Instead of eliminating distortions within the drug pricing system, this proposal could create and exacerbate perverse incentives that disadvantage patients and taxpayers. It also doesn’t require insurers to pass the massive rebates they receive from drug companies through to patients to lower their out-of-pocket costs, or allow patients to pay their costs over time to enhance access and improve health outcomes. “We’ve said all along that we’re willing to be a part of a solution that improves Medicare for vulnerable patients and enhances its sustainability, but the Senate proposal falls short. As the legislative process unfolds, we will work with lawmakers on both sides of the aisle to encourage a more holistic and balanced approach. That’s the only way to ensure our biotech companies can continue delivering innovative treatments and that those treatments are available to all patients with out-of-pocket costs that are affordable.” ###
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BIO Comments on FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations
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Human Health  •  Letters, Testimony & Comments  •  July 19, 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.
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BIO World Congress Showcases Green Solutions to Address Global Challenges
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Agriculture & Environment, Food & Farm Innovation, Sustainable Fuels  •  Press Release  •  July 11, 2019
As presidential candidates trek across the Hawkeye State and campaign on addressing society’s most pressing challenges, biotech innovators wrapped up four days of showcasing the scientific solutions to climate change, hunger, pollution and energy security.
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White House Deals Blow to Seniors, Withdraws Plan to Lower Out-of-Pocket Drug Costs
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Human Health, Cost & Value of Biopharmaceuticals  •  Press Release  •  July 11, 2019
BIO’s President and CEO Jim Greenwood issued the following statement after it was reported that the Trump administration is withdrawing its proposed rebate rule that would have required savings from drugmakers' rebates be passed along to seniors enrolled in the Medicare drug benefit program.
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Bipartisan Bill Will Strengthen Patent Rights and Protect U.S. Leadership in Biotechnology Innovation
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Intellectual Property, Patents  •  Press Release  •  July 10, 2019
Strong patent rights are essential to finance the revolution in biotechnology discoveries from the lab to the patient, farmer, and consumer
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BIO Comments on FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
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Human Health  •  Letters, Testimony & Comments  •  July 8, 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics.
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