It’s rare to hear a federal government person publicly put a time stamp on when things are coming out. Because who wants to speculate and then be wrong?
On the record.
To a reporter.
Who will probably write about how you were wrong (and then tweet about it).
So when Scott Gottlieb, commissioner of the Food and Drug Administration said last week his agency would be releasing several policy documents “this week,” you better believe my ears perked up (as did probably everyone else’s in that hotel ballroom).
One of those announcements would make good on a plan he announced this summer for regulating regenerative medicine products. Gottlieb made his comments at the Friends of Cancer Research annual meeting Nov. 15, so it was already halfway through the week. Meaning, a lot would have to move in two business days.
Sure enough, the next morning at 8:45, the FDA put out in the pre-Federal Register announcements a set of four guidance documents on regenerative medicine, following through on plans the agency announced earlier this year.
The FDA has approved about 15 cellular and gene therapy products thus far. By replacing or repairing tissue and organs when traditional medicines don’t work, regenerative medicine has the potential to provide enormous relief for patients who are suffering from serious conditions. But when stem cell clinics sell unapproved therapies, like the ones the FDA went after this summer, Gottlieb said it puts the entire industry at risk and endangers vulnerable patients seeking relief.
The guidances—two final, two draft—were broader than this summer’s enforcement actions and sought to clarify when research on regenerative medicine constitutes activities that require FDA oversight. The idea is to make it easier for clinics and researchers to understand how to color inside so to speak and in turn allow the FDA to exert its authority as an enforcement agency.
At first read, everyone from the academic medicine folks to regenerative medicine groups to one of the leading bioethicists in stem cells told me they support of the overall framework and the bigger picture of what the FDA was trying to do, with a few exceptions here and there. I expect there will be even more nuanced comments that come in the two draft guidances, which are due by Feb. 15.
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