Dr. Vinay Prasad’s brief and tumultuous tenure inside the FDA may not be over. Days after the CBER director abruptly departed, FDA Commissioner Dr. Marty Makary told reporters he wants Prasad back. 

For gene therapy developers, there’s a lot on the line. Before leaving the agency, Prasad led a contentious standoff with Sarepta Therapeutics amid safety concerns for its gene therapies and multiple patients deaths. His quick move to briefly yank a Sarepta DMD gene therapy off the market harkened back to past criticisms he levied against the FDA for approving some gene therapies too quickly. 

Analysts expressed hope that a new CBER director could reignite a more favorable regulatory climate for gene therapies, many of which are already facing challenges on the market. But if Prasad returns, or a more hardliner takes his former post, those struggles could continue. 

Today, we’re looking at the speedbumps hampering growth for approved gene therapies and at how Ferring Pharmaceuticals hopes to buck that trend by building off a strong launch. 

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