Generally, life sciences law is an umbrella term that broadly encompasses a wide range of policy judgment, scientific discovery, and legal matters that impact how medical devices, drugs, biotechnological products, and pharmaceuticals are developed, produced, distributed, and used. Ideally, the field encompasses a broad array of endeavors that typically focus on how to promote the healthy lifespan of flora and fauna (both animals and plants). In this regard, the primary focus of participants in this field entails how to develop and mark a broad range of interventions, services, and products.
While the enterprises of biotechnology, medical device, and pharmaceutical are probably the most typical examples within this field, the life sciences industry also includes a range of other subjects and areas. These include, but are not limited to labeling & advertising of medical devices and drugs, off-label use of pharmaceuticals and drugs, zoological & veterinary enterprises concerned with promoting the health of animals, the development, approval, manufacture, promotion, advertisement, and sale of new medical devices and drugs, medical research & technology, handling of biomedical waste & tissue samples.
Other areas include anatomical gifts, clinical trials of drugs, procedures, and medical devices, the transfer, ownership, transportation, storage, and collection of tissue, gene studies & genomics, analyzing biological samples & tissues, drug & human trials, pest control & disease mitigation industries, scientific studies & clinical investigations, evidence-based medicine & technology assessment, and botanical enterprises concerned with promoting the health and propagation of plants.
In light of these subjects and areas, it goes without saying that as a highly-regulated field of life, the life sciences industry is marred with a dozen ethical issues and, consequently, significantly high in employee claims seeking to “blow the whistle” on allegedly unethical, criminal, and unlawful practices. As you would expect, this will be the primary focus of our blogs that will be published under this series.
In Part II of this new series, we shall move the discussion forward and hammer on “Retaliation & Whistleblowing Claims under the Life Sciences Industry.”
In the meantime, stay tuned for more legal guidance, training, and education. In the interim, if there are any questions or comments, please let us know at the Contact Us page!
Always rising above the bar,
Isaac T.,
Legal Writer, Author, & Publisher.