BIO supports the creation of federal standards to protect the confidentiality of an individual's medical information, including the results of genetic testing.Genetic testing provides important opportunities to improve patient health. These tests can be used to diagnose the presence of disease. Equally, they can provide information that can be used to reduce the risk of future disease and enable earlier and more effective treatment if and when disease occurs.The recent acceleration in the development of new genetic tests has helped focus public attention on the broader issue of the need to protect the privacy of medical information in general, including but not limited to genetic information. Genetic testing provides information that is comparable to that which may be obtained by using other diagnostic methods. As such, it forms part of the continuum of medical information. For example, testing for the presence of a gene yields information that is similar to testing for the protein that is encoded by that gene. Even something as basic as a family medical history, which provides the physician with information critical to the diagnosis, prevention and treatment of disease, can be misused to discriminate against an individual or family.These examples highlight the need to protect the privacy of, and safeguard against misuse of, all personal medical information, regardless of the method by which it is obtained. For this reason, BIO believes that Congress should enact a comprehensive bill with respect to the privacy of all medical information, including genetic information, rather than a bill that treats genetic privacy issues in isolation. Legislation focusing exclusively on genetic information runs the dual risk of failing to address the larger issue of medical privacy while inappropriately stigmatizing genetic information in the public's mind.The recently enacted health insurance reform (Kassebaum-Kennedy) law serves as an example of an approach that recognizes the…

IntroductionIn the era of data-driven medicine, where all parties seek more, not less, information about the safety, effectiveness, and value of treatments, fostering informed communications among all stakeholders is critical. Today, the wealth of information about medicines is more comprehensive and complex than ever before. Scientific knowledge and new findings go far beyond data sets produced from clinical trials, often are outside the scope of the parameters established by Food and Drug Administration (FDA) regulations, and often outdate the FDAapproved labeling. In addition to information in the approved labeling for medicines, biopharmaceutical companies continually generate and collect important data and analyses that can benefit patient care and enhance the efficiency of our health care system.To exercise sound medical judgment in treating patients, health care professionals must understand the full range of treatment options, including both established and emerging information about available medications. Biopharmaceutical companies are uniquely positioned to help health care professionals achieve the best outcomes for patients, because companies can provide timely, accurate, and comprehensive information about both approved and unapproved uses of the medications they research, develop, and bring to patients. PhRMA, BIO and their members believe that the availability of a wider range of truthful and non-misleading information can help health care professionals and payers make better informed medical decisions for their patients, which in turn will benefit patients.In order to support the best use of scientific information for patient care, PhRMA and BIO endorse these Principles on Responsible Sharing of Truthful and Non-Misleading Information About Medicines with Health Care Professionals and Payers. These Principles are intended to form the basis for defining new and clear regulatory standards governing responsible, truthful and non-misleading…

The Biotechnology Innovation Organization (BIO) is committed to the socially responsible development and use of biotechnology to help save or improve lives, improve the abundance of food and reduce agriculture’s environmental impact, develop renewable sources of energy, and reduce the production of pollution in manufacturing.  We encourage discussion of the ethical and social implications of scientific developments in biotechnology.  As our companies work to develop promising new technologies to benefit humankind, applications of these technologies also may raise ethical questions.  To help us examine bioethics issues as they arise, we have an established BIO Board Standing Committee on Bioethics.Our Bioethics Committee was established to define, articulate, and communicate effectively BIO's positions with respect to major bioethics issues.  As part of this commitment, we have developed these principles and post them publicly.PreambleBIO represents biotechnology companies, academic institutions, state biotechnology centers, and related organizations throughout the United States and in more than 30 other countries.  The members of BIO apply biological knowledge and techniques to develop products and services for use in health care, agriculture, energy, environmental remediation, and other fields.  The benefits of these products and services include saving lives threatened by disease, protecting the blood supply from some infectious agents, increasing food production on less land and with fewer chemical, water, and energy inputs, diversifying energy sources, and aiding the clean-up of hazardous wastes.While biotechnology can greatly improve the quality of life, we recognize that this technology should be approached with an appropriate mixture of enthusiasm, oversight and humility.  Biotechnology can provide useful tools for combating disease, hunger, climate change, and environmental contamination, but it should not be viewed as a…

The public has a strong interest in protecting research and research participants. Federal policy must find the right balance in protecting participants while allowing critical research to continue.BIO companies' research leads to cures and treatments for disease. Today, there are 168 biotech products on the market and they have helped a quarter billion people worldwide. Another 371 biotech medicines in late stage development are targeting more than 250 diseases.This research cannot go forward without the human subjects who volunteer to participate. Research depends on participants' good will. Some may be just curious and interested in helping, while others may be vulnerable or scared, in turning to the unknown for help for their disease. In addition to facing their disease, in many situations, a primary motivation is to help find cures for the next generation of people with their disease. Patients deserve respect and admiration, and protection from inappropriate risks that they may be in no position to evaluate.BIO has long advocated protection for research participants. Its Statement of Ethical Principles, drafted by its Bioethics Committee and adopted in 1997, pledges adherence to strict informed consent procedures to ensure that research participants are fully aware of the potential risks and benefits of that research.In addition, two years ago, BIO adopted "Principles for Federal Law To Protect Research and Research Participants." BIO stated that its interest in adopting the principles was "to protect the strong public interest in the results of research and public confidence in the research process." These Principles have provided BIO with a basis for participating in what it hoped would be an active legislative and regulatory agenda strengthening and standardizing the federal laws protecting human subjects so that they apply to all research no matter what funding source.Since then, legislators have debated the relevant issues, and BIO has provided…

PreambleBIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.Research involving animals has been critical to understanding the fundamental processes of human biology that are so integral to modern medicine. Biotechnology companies have depended on this research to develop more than 160 drugs and vaccines approved by the U.S. Food and Drug Administration, helping 325 million people worldwide and preventing incalculable human suffering. There are now a number of research techniques involving animals, which hold great promise for aiding humanity. However, many serious diseases such as AIDS, Alzheimer's Disease, Parkinson's Disease, hepatitis, cancer, cardiovascular diseases, and diabetes, are still poorly understood and treated. Therefore, new and more effective therapies and diagnostics are desperately needed to improve the lives of patients.BIO members are compelled by ethical and legal concerns to evaluate the safety and efficacy of potential medicines and food products before they are given to humans and animals; the use of animals in research is a requirement for many such products. The appropriate and responsible use of animals is therefore an indispensable part of biomedical and agricultural research. BIO members are committed to act ethically and to apply high standards of care when using animals in scientific procedures.BIO members are committed to reducing the number of animals used for research when it is possible to develop, validate and use alternative methodologies consistent with regulatory requirements for testing, while maintaining the scientific integrity of the research. BIO affirms and upholds the science-based regulation and oversight of animal research by the U.S. Food and Drug…

Reaffirming and Broadening Our Commitment to Transparency and Clinical Trial Data SharingThe member companies of the Biotechnology Industry Organization (BIO) are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.Drug development is a highly complex, costly, lengthy, and competitive endeavor. The interests of all participating stakeholders must, therefore, be carefully balanced when considering increased access to clinical trial data. Foremost, study participants themselves must have confidence that their personal medical information and privacy will be respected in accordance with the terms of their informed consent and in compliance with relevant laws and regulations. Additionally, in order for innovative biotechnology companies to successfully attract the investment necessary to fund a drug or biologic program over the decade or more required for its development, it is imperative that data not be disclosed prematurely or in a manner that does not protect confidential and proprietary information. Moreover, most BIO member companies are small, pre-revenue enterprises that operate with limited resources. While evaluation of requests for additional data will divert resources from their core mission of directly developing innovative therapies, BIO members recognize the value of supporting, to the extent possible, qualified external medical and scientific research.We are, therefore, committed to building upon our routine publication of clinical research results and ongoing collaborations with academic and government researchers in order to support additional efforts to improve public health.How Do We Currently Promote Transparency and Access to Clinical Trial Data…

September 2017Genome editing is an emerging technology that allows for the targeted modification of DNA for a multitude of applications. In human health, researchers are exploring ways to use genome editing of somatic cells to treat or prevent genetically defined human diseases.Clinical use of genome editing in somatic cells, or non-heritable cells, is currently subject to oversight similar to that of other advanced biotherapeutic technologies such as gene therapy. Specifically, the combined activities and responsibilities of the US Food and Drug Administration (FDA), through its statutory role as the regulator of drug development, and the NIH/Recombinant DNA Advisory Committee (RAC), as the forum for public discussion, serve in this oversight capacity to protect patients while ensuring that important research moves ahead.In February 2017, the National Academy of Sciences and the National Academy of Medicine Committee on Human Gene Editing, after careful review of scientific, ethical and public views on human genome editing, released a report supporting the current regulatory and oversight mechanism for somatic cell gene editing for the potential treatment of disease. The report also concluded that genome editing in humans for purposes other than treating or preventing a disease or disability should not proceed at this time. BIO fully agrees with these two conclusions.Regarding the clinical use of genome editing in germline cells (where the DNA edit is passed on to future generations), the 2017 authors noted that “there is a need for caution in any move toward germline editing, but that caution does not mean prohibition.” The Committee concluded that under a very strict set of 10 criteria, including when 1) no other reasonable alternatives exist, 2) government restrictions have expired, and 3) research on risk/benefit standards has advanced in the field, certain germline editing could be permissible for the treatment of disease.BIO views the science of germline…