David Rosen Quoted on Health Care & Life Science Regulatory Changes to Watch

Foley & Lardner LLP partner David Rosen is quoted in the Pharmaceutical Technology article, “Regulatory changes in the US and UK to watch in 2024,” offering insight on the significant amount of change the health care and life sciences sector may see in the next year.

Rosen detailed how change in the U.S. Food and Drug Administration’s (FDA) plans to regulate laboratory developed tests (LDTs) as medical devices could create uncertainty.

“These products have been on the market for quite some time,” Rosen explained. “I think what the FDA is saying is that they want to have more data so that they can have confidence in the reliability of these tests and the ability of practitioners to rely on the results that come from these tests. They are going to have to staff up to be able to do it cause it’s going be a challenge.”

Rosen also commented on the Biden Administration’s plans to allow agencies to use march-in rights to seize patents of government-funded drugs if their producers price them too highly. “

I think that there is going to be a lot of controversy and litigation over this, that’s for sure,” he noted. “I think that we want the National Institute of Health to participate because of the nature of the cutting-edge research it does, and to have the government understand what is going on, but to allow the government to come in and seize those patents, they will need to strike a balance.”