Wednesday, March 06, 2019

The FDA and the Loss of Gottlieb: What Does it Mean for Stem Cell Research?

Scott Gottlieb at his earlier Senate confirmation hearing

"Panic Attack" --That's what the headline this morning said about the resignation of Scott Gottlieb as head of the Food and Drug Administration(FDA). 

The STAT article addressed the general biotech field and its worries. Gottlieb's departure, however, also creates some uncertainty involving California's $3 billion stem cell agency. Known as the California Institute for Regenerative Medicince (CIRM), the agency is backing 51 clinical trials, all of which are regulated by the FDA.

STAT is one of the more authoritative outlets dealing with medical research news. Its Gottlieb piece reviewed his impact on stem cell and regenerative medicine and what his loss might mean. The full headline said, 
"Scott Gottlieb's Sudden Resignation Will Give Biotech a Panic Attack"
The article by Matthew Herper and Adam Feuerstein said,
"Without Gottlieb at the helm, there is uncertainty. And there is nothing that scares investors and biopharma more."
Most of the news coverage of Gottlieb's surprise resignation focused on his efforts regarding vaping and opiods.  But STAT was not alone on discussing the stem cell/regenerative medicine issues. A piece on Politico said, 
"Gottlieb worked to advance cell and gene therapies, a promising new area of medicine. Under his leadership, the FDA put out a framework for regenerative medicines, designed to accelerate the approval of the most promising gene therapies. At the same time, Gottlieb balanced promoting legitimate new treatments with crackdowns on bad actors who were taking advantage of patients by marketing unapproved, unproven and potentially dangerous treatments."
In California, the state has invested roughly $2.5 billion so far in stem cell research with goal of bringing products to market. That is a process that heavily involves the FDA.

Indeed, a top official of the FDA will be speaking next month at a San Francisco conference sponsored by the agency and UC San Francisco. The topic? "Regulation and the Office of Cell Therapy and Gene Therapies Expedited Reviews"

It is far from clear what will emerge at the FDA concerning regenerative medicine or whether Gottlieb's approach will continue.  President Trump may leave the post vacant for some time. He will be heavily lobbied by interests that have opposed Gottlieb's more visible efforts concerning vaping and opiods. 

Trump also will feel pressure from the regenerative medicine industry. But given the multiplicity of issues facing the president, the FDA is not likely to be high on Trump's priority list. And then there are Senate confirmation hearings on any appointment.

Meanwhile we can expect to see more analysis in the coming weeks of what it all means for stem cells and regenerative medicine. 

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