FDA Commissioner Scott Gottlieb, M.D., has backed away from an earlier commitment to publish complete response letters (CRLs). Gottlieb talked up the prospect of releasing redacted versions of the letters in his confirmation hearings but has now watered down his interest in the idea.
People inside and outside the FDA have long discussed the publication of the CRLs the agency sends to companies to notify them it is rejecting their applications for approval. Such transparency would enable everyone to know why the FDA rejected an application. Today, researchers, investors and other interested parties rely on the honesty and transparency of the companies that receive CRLs to get a glimpse at the FDA’s thinking.
That looked set to change with the appointment of Gottlieb, who presented himself as a proponent of the publication of CRLs earlier in his career and during confirmation hearings ahead of politicians voting for him to become FDA commissioner.
Yet, in his first big speech on transparency Tuesday, Gottlieb has scaled down his CRL plan. Rather than release all the CRLs the FDA issues, Gottlieb is now exploring “whether it would be possible” to share redacted response letters that have “significant public health value.” Gottlieb argued that some CRLs, such as those related to manufacturing failings, are unlikely to inform clinical practice and therefore the effort of releasing them outweighs the benefits of hoarding them.
“Releasing all the CRLs would be administratively burdensome, given the likelihood we would continue to redact certain proprietary information from these letters. And not all the letters have information that would directly inform clinical practice,” Gottlieb said in the speech.
The upshot is the FDA is now looking into whether to release a “subset of the complete response letters where there are especially important public health reasons.” Gottlieb cited “letters that have safety-related findings or recommendations” with implications for products already on the market as an example of those that could be released. The commissioner thinks publication of these letters may cut the number of futile trials and inform clinical practice, thereby benefiting public health.
That policy falls well short of what was expected of Gottlieb—particularly as even this diluted plan might not come into force—but is nonetheless an historic step forward considering the standards of transparency at the FDA.
The volte-face on CRLs was the most eye-catching of the details Gottlieb shared in his speech. But it also contained other revelations, some of which move the FDA transparency agenda into new areas.
The commissioner outlined a pilot project that will evaluate the disclosure of clinical study reports following the approval of a drug. Gottlieb thinks sharing these summaries of the methods and results of trials will give academics access to data while shedding light on the FDA’s decision-making process.