Regulation to Reinforce the Evidentiary-Science Base of U.S. Medicine in the Age of "Omics"

Authors

• Michael J. Malinowski, Louisiana State University Law CenterFollow

Abstract

United States’ technology transfer law and policy (TTLP) integrates government, academia, and industry—a “triple-threat” research and development (R&D) methodology—and harnesses commercial incentives to stimulate market application of federal government-funded invention. TTLP, which has proven a potent catalyst for remarkably prolific biomedical R&D since Congress enacted its cornerstone legislation in 1980, is transforming U.S. medicine to molecular medicine—to personal genome medicine (PGM)—in real time. A genomics (gene function in the context of an organism’s entire genome, meaning its full set of genetic instructions) complement to the Human Genome Project (HGP) emerged in the 1990s. Genomics has given rise to a portfolio of “omics” fields that represent a biomedical research perspective shift over the last two decades to multifaceted systems of biology on the molecular level, with simultaneous analysis of thousands of molecules and the way they influence each other. During more than four decades of expansive implementation, TTLP has directly infused industry influence from the laboratory bench to clinical research, and on the stakeholders (individuals and institutions) engaged in both. During this same span of time, U.S. medicine has become much more commercial through cumulative waves of managed care, conversions from not-for-profit to for-profit, consolidation, and private equity ownership of medical practices. An ongoing proliferation of inauthentic authorship, research misconduct, and outright fraud in peer-reviewed science and medical literature undermines research integrity and reliability. TTLP, while a profound prescription medicines (Rx) R&D enabler, has not been complemented with regulation—self-regulation by the U.S. medical profession, governmental regulation, or a combination of the two—to sufficiently protect the evidentiary-science base of medicine in an age of omics commensurate with the way the base of U.S. medicine was established, protected, and promoted during its formative twentieth century. This article discusses the preceding and introduces law-policy proposals to reinforce the evidentiary-science base of U.S. medicine in our omics century.

Recommended Citation

Michael J. Malinowski, Regulation to Reinforce the Evidentiary-Science Base of U.S. Medicine in the Age of "Omics", 28 SMU Sci. & Tech. L. Rev. 485 (2025)