FDA to release more details on new drugs

Information will give easy access to clinical trial data.

The Food

WASHINGTON — 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 approv

ing 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 academicians, focused on 18 recommendations for making the agency’s decision-making less opaque. The suggestions were part of a report called Blueprint for Trans- parency.

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 clinical study reports for recently approved drugs. These summaries, which are generated by drug-com- pany sponsors of the treatments, spell out the methods and results of clinical tri- als. The data don’t include patient-identifiable infor- mation.

The pilot is expected to ultimately include nine drugs volunteered by their spon- sors for the effort, Gottlieb told Joshua Sharfstein, a Johns Hopkins Bloomberg School of Public Health professor, in a question-and-an- swer 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,” espe- cially on the safety and effi- cacy 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-re- search information by adding a study’s identifier number from Clinical Trials.gov to all FDA materials for a specific product. Clinical Trials. gov is the database of studies maintained by the National Institutes of Health.

On another transparency issue, Gottlieb said the agency is exploring whether there is “subset” of “complete response letters” that can be released. Such letters to drug companies detail why their drugs were not approved. He said the FDA is looking at possibly releasing information involving safety issues. Critics of the pharmaceutical industry have long complained that the companies don’t always give the public accurate and

comprehensive explanations of why their products were rejected.

THE NEW YORK TIMES Bruce Fenstermacher meets with Dr. Wassim Abida as he begins a clinical trial of an experimental drug that could target a rare mutation in his cancer at the Memorial Sloan Kettering Cancer Center in New York.