FDA to review its human testing protocols

The FDA is launching a review of its process to allow drug companies and other research entities to perform clinical testing on humans.

Under the investigational new drug, or IND, phase of drug development, researchers obtain permission to start human clinical trials. Once an IND is submitted, the FDA has 30 days to object, otherwise it automatically becomes effective and clinical trials may begin.

The FDA contracted with Eastern Research Group to figure out if the current approval pathway needs refinement.

The agency receives 4,000 IND requests per year.

Pending White House Office of Management and Budget approval, Eastern Research Group will conduct surveys and interviews with companies and organizations submitting IND requests to learn about their experiences in seeking approval, as well as with FDA staff on their approach to reviewing such applications.

The hope is to find out what is working well with the process, ongoing challenges and opportunities for improvement.

That could be good news for drugmakers. If the FDA has a question about an IND it can continuously freeze the 30-day clock, according to Marilyn Apfel, chief operating officer at xFDA, a consulting firm.

"It is a slow deliberative process, so any identification of chokepoints is useful if can be addressed," she said.

Eastern Research Group will develop aggregated summaries of survey and interview responses and prepare a report which the FDA will publish. It will also hold a public meeting about the assessment.

David Gortler, an associate professor of pharmacology at Georgetown University and a former FDA medical officer, hopes the survey will shed more light on the results of clinical studies that moved forward by default.

As of now, the agency has no way of tracking such information unless the trials are used to support new drug applications. Many trials fail due to lack of funding, or negative health outcomes, Gortler said.

"When I was approving an IND, I don't think I ever heard back from single one as far as what happened, where it took place, or if someone got injured," Gortler said. "I think that's very useful to know. I mean we're experimenting on human beings for crying out loud here, these are not petri dishes or rodents they're experimenting on."

Depending on the results of the survey, the IND application process could change, especially if the survey uncovers widespread safety concerns. That would be a big deal as the IND pathway has not been updated in decades, Gortler said.