FDA pushes off stem cell hearing

The Food and Drug Administration has indefinitely postponed a public hearing on stem cell regulation due to what it called “considerable interest.”

“Due to this interest, and to give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents,” the administration said on its website.

The April 13 hearing was shaping up as a public showdown between opponents and supporters of stem cell-based research and therapies. Seen by some as an opportunity to clear up misconceptions – including passionate concerns about the use of embryonic materials – the hearing would also allow legitimate researchers to challenge untested, possibly dangerous therapies, and for doctors with successful stem cell portfolios to share their progress.

No date has been set for a rescheduled hearing, though the FDA said it would happen “later this year.”

In addition to gathering more public, researcher and other stakeholder comments for its draft guidance documents, the agency also intends to schedule a “scientific workshop” prior to the rescheduled public hearing to glean information directly from clinical researchers and manufacturers of cell-based products.

The workshop will be important for “the generation of scientific evidence to facilitate the development of safe and effective cell-based therapeutics,” according to the FDA website.

Information on the rescheduled public hearing, including location and registration information, will be made available on FDA website and will be published in the Federal Register. Updates will include information on how stakeholders interested in speaking, including those scheduled to speak at the April 13 hearing, can sign up.