The Food and Drug Administration is taking steps to make it easier for doctors, patients and researchers to get access to clinical trial data amassed during the process of approving new drugs, Commissioner Scott Gottlieb said Tuesday.
Gottlieb announced the actions just before a speech on FDA transparency at a Washington forum. The meeting, attended by researchers and academics, focused on 18 recommendations for making the agency's decision-making less opaque. The suggestions were part of a report called Blueprint for Transparency.
The FDA has long said it is sharply limited in what information it can release because it often is dealing with drug companies' proprietary material.
Gottlieb, in his statement and in remarks to the forum, said the agency is starting a pilot program this month to release portions of clinical study reports for recently approved drugs. These summaries, which are generated by drug-company sponsors of the treatments, spell out the methods and results of clinical trials. The data don't include patient-identifiable information.
The pilot is expected to ultimately include nine drugs volunteered by their sponsors for the effort, Gottlieb told Joshua Sharfstein, a Johns Hopkins Bloomberg School of Public Health professor, in a question-and-answer session at the forum.
The release of the study reports, which can run hundreds of pages, will allow researchers and others “to do more analysis around our decision-making,” especially on the safety and efficacy of new drugs, Gottlieb said. Some of the information is already released by the agency but in a format that is difficult for lay audiences to use, he said.
The commissioner also said the agency will make it easier to track clinical-research information by adding a study's identifier number from ClinicalTrials.gov to all FDA materials for a specific product. ClinicalTrials.gov is the database of studies maintained by the National Institutes of Health.
On another issue, Gottlieb said the agency is exploring whether there is a “subset” of information from its “complete response letters” to companies that can be publicly released. Such letters detail why a drug was not approved. Before becoming commissioner, Gottlieb expressed support for releasing the letters after redaction of confidential commercial information. He now says it would be “administratively burdensome” to release all such letters, with the agency instead exploring releasing parts related to patient safety.
Peter Lurie, a former FDA official and current president of the nonprofit Center for Science in the Public Interest, said Gottlieb's position is a tentative but encouraging step. While a top FDA official, Lurie led a 2015 study that showed pharmaceutical companies don't disclose the vast majority of information in the letters.