David Rosen Discusses Health Care and Life Sciences Sector Focuses in 2025
Foley & Lardner LLP partner David Rosen shared insight on what the health care and life sciences sector is focused on in the lead up to the new year in the Law360 article, “What We Learned About Life Sciences Asset Class In 2024.”
Rosen said compliance and enforcement concerns are hanging over the U.S. Food and Drug Administration as the new administration prepares to take office. Potential leadership changes at other agencies like the Centers for Medicare and Medicaid Services could also bring a “tidal wave” of changes to the health care industry at large.
Rosen noted that as the FDA is struggling to enforce quality standards for a global supply chain, drug companies may be less concerned with the agency’s scrutiny of their operations than before.
“People were really nervous and scared when they were called in to meet with the director of the Office of Compliance, and they wanted to toe the line,” Rosen said of FDA’s oversight practices during his 14 years with the agency. “We’ve seen differences in the enforcement posture at FDA over the years.”
He added that another focus for the industry is product quality, with the issue leading some U.S. drugmakers to eye investing in more domestic production.
“Everybody wants to get the product, but if you can’t get it, or if it’s held up in customs, that’s a big deal in the pharmaceutical and medical device world,” Rosen added.
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