FDA has a date for stem cells hearing

The Food and Drug Administration has rescheduled a critical public hearing on potential regulations for the burgeoning stem cell industry.

“Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products” will now be held Sept.12 and 13 inside the Masur Auditorium on the National Institutes of Health’s Bethesda, Md. campus.

Originally scheduled for April 13, the hearing was postponed due to what the FDA called “considerable interest.” The agency, which didn’t immediately set a new date, said it was hitting the pause button to “give stakeholders additional time to provide comments” and to solicit further input on draft guidance documents.

The hearing was shaping up as a public showdown between opponents and supporters of stem-cell based research. Proponents see the hearing as an opportunity to correct misconceptions, including passionate concerns about the use of embryonic materials, while opponents – including some legitimate stem-cell researchers – are likely to challenge untested, possibly dangerous therapies already in practice.

The public hearings are also expected to attract doctors with successful stem cell portfolios, on hand to share their progress.

The FDA still intends to schedule a “scientific workshop” prior to the Sept. 12-13 hearing “to identify and discuss scientific considerations and challenges,” according to the agency’s Office of Media Affairs.

The workshop will also “help inform the development of [Human Cells, Tissues and Cellular and Tissue-Based Products] subject to premarket approval, including stem cell-based products,” the FDA said.

Information about the rescheduled public hearing, including registration information, is coming soon to the FDA website.