FDA Releases Plan To Improve Drug Approval Process, Seeks Public Comment

Federal drug regulators are seeking public comment on proposed changes for the process of approving new drugs, which they say will increase transparency.

The FDA issued a Federal Register notice on June 26, detailing its new drugs regulatory program modernization. The proposed rules would result in the agency posting clear summaries of the safety and effectiveness data from drug trials, as well as parts of the clinical study reports.

Since last year, the agency has begun testing a pilot program designed to improve transparency. This includes the Clinical Data Summary Report (CSR) Pilot Program, which posts portions of clinical study reports from drug manufacturers’ new drug applications. To date only one drug company has agreed to participate.

Another aspect in the works is an integrated review process and document template which would contain interdisciplinary assessments, replacing older documents where each discipline had a separate application review document. The goal of these integrated documents is to have a summary of all of the drug’s assessments in one form for easy access.

“As part of our efforts to enhance transparency around our drug approval decisions, we have been exploring ways to build on how we share information about product approvals. We are especially focused on information that can improve patient care and better inform health care professionals about the products they prescribe,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today we have issued a request for public comment to receive stakeholders’ thoughts about these programs so that we can continue to provide information that is clear and transparent.”

There has been growing public concern in recent years about the FDA’s drug approval process. In a study published in September 2017, Harvard researchers found that about a third of all new FDA drug approvals went through an expedited process which fast-tracked them to the market.

Researchers discovered that 94% of those expedited drugs had to have a safety-related label change every year. However, even among drugs which went through the full approval process 68% required safety warning changes in the first year, according to those findings.

That study came following a number of similar reviews by independent researchers, including a study published in The BMJ in May 2017, which looked at prospective controlled clinical studies for all drugs that were published after the FDA initially approved them between 2005 and 2012. All of the drugs included in the study were approved on the basis of a single pivotal clinical trial.

The FDA is accepting public comments on the proposed approval process changes through August 26, 2019. Comments can be submitted to https://www.regulations.gov or can be submitted by mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

All submissions must include the Docket number: FDA-2019-N-2012.