Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served to convene an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.