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Gilead Life Sciences, Inc. is facing charges of negligence in California, not because its HIV/AIDS drug was defective, but because the company delayed the release of an allegedly safer drug.

After 30 years of wrangling with industry and Congress, the Food and Drug Administration (FDA) is in the formal process of trying to expand its authority to regulate lab developed tests (LDTs). The agency is reviewing some 6,707 comments it received during the 60-day comment period, which ended on December 4. The FDA contends LDTs are medical devices subject to FDA authority under the Food, Drug, and Cosmetic Act (FDCA).

Americans are taking prescription drugs over longer periods of their lives, and the trend is raising new questions about the costs’ impact on the economy, society, and health care in general. Using data from the Medical Expenditure Panel Survey, the Human Mortality Database, and the National Center for Health Statistics, Jessica Y. Ho found not only is prescription drug use spreading, but high levels of use begin early. Babies born in 2019 could take prescription drugs for roughly half their lives.