- Endpoints' John Carroll reports that FDA Commissioner Scott Gottlieb, M.D. has apparently backtracked on a confirmation hearing pledge to publish (redacted) Complete Response Letters (CRLs) as part of an overall push for greater agency transparency.
- In an address this morning, he said publishing CRLs would be "administratively burdensome" due to the need for redacting proprietary information, adding that not all CRLs contain information related to clinical practice (e.g., manufacturing issues). He believes there may be a subset of CRLs containing important public health information that could be published but apparently stopped there.
- Thus far into Gottlieb's tenure, the FDA has failed to publish three CRLs.
- Mr. Carroll says the public has the right to know the contents of FDA rejections. His solution? Forget redaction and publish each CRL as is. Administrative burden removed.
- Selected tickers: PJP IHE XPH PPH IBB XBI BIB
- Now read: Valuation Dashboard: Healthcare - Update
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