https://www.nytimes.com/2019/05/26/o...ments-fda.html

The agency says it will continue to prioritize regulatory actions against those who place people’s health at risk.

May 26, 2019

To the Editor:

“An Unproven Cure” https://www.nytimes.com/2019/05/13/h...&module=inline (Science Times, May 14), about stem cell treatments, describes the Food and Drug Administration’s approach to the regulation of stem cell products as “industry-friendly.” We disagree.

The F.D.A. has made clear to industry and the public that while it is taking a risk-based approach to regulatory actions, the agency will continue to protect patients from the most egregious actors in this field. We continue to work with legitimate investigators to help facilitate the development of promising stem cell therapies.

The agency will continue to prioritize regulatory actions against those who place people’s health at potential significant safety risk because their unapproved products are unsafely manufactured or are being administered in a manner that puts patients at risk — for example, directly into the bloodstream or central nervous system.

The F.D.A.’s regulatory and enforcement efforts have included correspondence with companies, like warning letters and even litigation. The F.D.A.’s primary responsibility is to promote and protect public health, and we take this responsibility seriously.

Ned Sharpless
Peter Marks
Silver Spring, Md.
Dr. Sharpless is acting commissioner of the Food and Drug Administration. Dr. Marks is director of the agency’s Center for Biologics Evaluation and Research.