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Government shutdown already affecting clinical trials industry

Friday, October 4, 2013

Last week, when the government shutdown began, stories of children with cancer unable to get into potentially life-saving trials at the National Institutes of Health (NIH) were the first clinical research-related ramifications reported.

Almost three quarters of the NIH’s 18,646 employees were on enforced leave as of Thursday, including many researchers who administer the grant programs that direct billions of dollars to researchers across the U.S.

Now, a few days into the shutdown, we’re seeing what the broader effects of the shutdown could be on the clinical research enterprise.

Currently, trials under way in both the public and private sectors are not expected to be affected, as dropping patients already enrolled in a clinical trial is “ethically inexcusable,” said Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor and head of the Division of Bioethics at New York University Langone Medical Center.

“Anything the government does that winds up abandoning vulnerable human  subjects with existing attachments to NIH trials, or trials anywhere, is simply morally heinous,” said Caplan.

Even so, if the shutdown continues, that could happen, as grant funding will begin to dry up for researchers, rendering them unable to continue funding their trials, he said.

In addition, the government-funded web sites that people typically use to find trials are not being updated.

And the FDA, which oversees the drug development industry, will also see some fallout. Due to being partially funded through user fees from the private sector, the FDA has not shut down entirely, but the agency has drastically scaled back its activities, and 45% of its 14,779 employees had been furloughed as of late last week.

The FDA has said no new regulatory submissions will be received during the shutdown and routine site inspections will be suspended, but prosecutions will continue.

Diana Caldwell, president and CEO of Pearl IRB, said her clients with products currently in the approvals process have already had their face-to-face meetings with the FDA canceled. That’s the bad news. The good news is that the FDA rescheduled the meetings to take place by phone.

“This isn’t silence from the FDA—they haven’t gone dark,” said Caldwell. “But behavior there is changing and we’re seeing delays start.”

— Suz Redfearn

Read the full story in this Monday’s CWWeekly.

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