Life Sciences Law
Life sciences law is a broadly-defined, umbrella term encompassing a wide array of scientific discovery, policy judgment, and legal issues that affect the development, production, distribution, and use of pharmaceuticals, biotechnology products, and medical devices. Other relevant areas include food, dietary supplements, crop technology, animal husbandry, and other aspects of sustenance, health, or productivity of man and animals. In each case, important underlying considerations are taken into account including, safety, effectiveness, societal need, cost, environmental impact, and technological evolution.
Legal practice in the life sciences area demands current and historical knowledge about relevant laws and regulatory entities, direct or consultative expertise in scientific methodology and data development, understanding the disciplines such as risk assessment and good manufacturing practice, and more. Legal services in the area may involve regulatory consulting, compliance review and advice, intellectual property and technology management, privacy law counseling, licensing and contracting expertise, business advice, financial investment, supply chain management, etc.
Issues confronted by attorneys practicing in the field of Life Sciences Law include:
- What is the difference between a "drug" and a "medical device"?
- What is required to bring these products to market? Are the significant differences, and whom do they affect (producers, distributors, healthcare providers, end consumers)?
- How are life science innovations translated across products? How do intellectual property protections apply?
- What regulatory agencies are involved? Are both federal and state-level agencies of concern?
The field within Health Care Law that concentrates on "Life Sciences" includes the following subjects:
- developing, approving, manufacturing, promoting, and selling of new drugs and medical devices
- clinical trials of medical devices, procedures, and drugs
- biomedical research and technology
- off-label use of drugs and pharmaceuticals
- technology assessment and evidence-based medicine
- clinical investigations
- institutional review boards (IRBs)
- medical research
- human trials
- scientific studies
- drug trials
- analysis of biological (tissue) samples
- genomics and gene studies
- tissue collection, storage, transportation, ownership and transfer
- anatomical gifts
- handling of tissue samples and biomedical waste
- medical research and technology
- advertising and labeling of drugs and medical devices
This sub-area of Health Law involves the interpretation and application of the following:
- anatomical gifts, laws, and regulations
- intellectual property laws (federal and state)
- Food and Drug Administration (FDA) laws and regulations
- PhRMA code
- AdvaMed code
- international treaties and codes
- U.S. Dept. of Health and Human Services (HHS), OIG Pharmaceutical
- Company compliance program guidelines
- state health laws and regulations