FDA Commissioner Gottlieb Proposes Changes for Greater FDA Transparency

FDA Commissioner Scott Gottlieb, MD, delivered the keynote address during a symposium, "Transparency at the US Food and Drug Administration,” hosted today by the Johns Hopkins Bloomberg School of Public Health. In his speech, Gottlieb announced a number of new initiatives to make the reasoning behind FDAs decision-making more transparent to all healthcare stakeholders.

“Transparency can be a powerful tool for innovation…the FDA’s goal is to advance transparency without reducing [the] incentive to innovate,” said commissioner Gottlieb.

Beginning later this month, the Center for Drug Evaluation and Research (CDER) is launching a pilot program to evaluate whether disclosing Complete Study Reports (CSRs) following the approval of drug applications can improve the public’s access to drug information. A CSR contains a detailed summary of bottom line information on the results of a trial.

“When we’re able to link to CSRs, it’ll make development of the review document more accessible. We are trying to come up with a more consolidated review memo, 1 document where you can see the consensus and disagreement all in one place, released at the time of the drug approval,” Gottlieb said, “This will allow third parties to run more analytics around our decision-making, and have research better informed by actual data.”

In addition, in order to increase transparency of clinical trial information through the clinicaltrials.gov website, there will now be a National Clinical Trial (NCT) number associated with all registered trials. This number will be linked on the trial's webpage so that it can be referenced throughout other documents the FDA publishes to make all the available data of a specific trial more readily accessible.

Finally, the FDA plans to explore whether it is possible to release additional information about complete response letters (CRLs) that could offer potentially significant health benefits through greater communication. However, Gottlieb did note that there is a legal issue surrounding the potential full release of CRLs because they are technically manufacturer information, and there would have to be a redaction of all proprietary information.

In response to the question, “Should people be worried that patient-level data will be disclosed [through the release of a full CRL]?” Gottlieb said, “This is not patient-level data. We want to make sure the data is presented in a way that someone who is an intelligent researcher and is aware of other data, cannot correlate it in a way that they would have patient-level data. We are working through the legal issues, [however;] initially this is voluntary. We’ll reach out to companies where we think this could be particularly relevant and could add to a more efficient process.”

Some stakeholders feel that Gottlieb’s new position on publishing portions of redacted CRLs that the agency deems relative to public health concerns directly contradicts the position Gottlieb took during his US Senate confirmation hearings. During the hearings, Gottlieb said he would publish full CRLs “after proper redaction of commercial confidential information,” rather than sections of the documents.

Gottlieb’s proposed changes come largely from a published blueprint by Joshua Sharfstein, MD, and Michael Stebbins, PhD, that appeared in JAMA last March, entitled “Enhancing Transparency at the US Food and Drug Administration: Moving Beyond the 21^st Century Cures Act.”