Ahead of vote, Gottlieb advocates for public CRLs

Scott Gottlieb said his advocacy for data transparency includes his support for public release of complete response letters for drug candidates. The comments, which were in written answers to questions posed by Sen. Elizabeth Warren (D-Mass.), came ahead of a scheduled vote by the Senate Health, Education, Labor and Pensions (HELP) Committee on Gottlieb's nomination as FDA commissioner, which was delayed until Thursday morning.

"I have long advocated that the FDA release more information related to its review process that could be used to better inform consumers and product developers alike," Gottlieb wrote. "This includes the complete response letters, after proper redaction of commercial confidential information. If confirmed, I will be committed to working with Congress, patients, industry, and stakeholders on the issue of data transparency and new ways that FDA could potentially make important information more readily available to the public."...