The FDA made waves in early September when it announced a plan to publicly release complete response letters (CRLs) at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency.”

At the same time, the FDA released 89 new CRLs, adding to the more than 200 that were previously made public in July and shedding more light on the agency’s often opaque review process. That earlier document dump, though, only included rejection letters for drugs that were eventually approved. Now, for the first time, the agency is releasing CRLs for unapproved drug candidates—including recent high-profile rejections such as Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug. 

Publicly airing the rationale for rejecting drug candidates is a significant shift for the FDA and a potential cause for concern for the biopharma industry.

To unpack what the new policy means for drug developers, Fierce Biotech’s Darren Incorvaia sat down with Torrey Cope, a lawyer with Sidley Austin who represents and advises life sciences companies on issues related to the FDA.

To learn more about the topics in this episode: 

• FDA releases ‘initial batch’ of more than 200 drug rejection letters 

• FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub 

• FDA misinterpreted efficacy data that prompted DMD rejection, Capricor claims 

• ‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process 

• 'Several concerning observations': FDA sheds more light on reasons it rejected drugs 

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