In October, I talked to a source inside the FDA who suggested that the agency was having a hard time keeping up with work-flow. I quoted him on this blog as explaining that since the FDA has committed to reviewing applications for approval of a new drug within 10 months, drug-makers have been submitting “shabbier” applications that contain less evidence about risks and benefits.
“For the drug-maker it’s a gamble. The company is betting that, because we want to make the 10-month deadline, we won’t send the application back,” said the source. And often, he acknowledged, the drug-maker is right. “If you find a problem or there is something missing and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.”
In the past, he added, a company submitting an application knew that if the application wasn’t up to snuff, the FDA would send it back. But those standards have fallen: “Now we send it back [only] if it’s really crappy.”
Yesterday the FDA Science Board dropped a bombshell in the form of a report which suggests that standards at the FDA haven’t just fallen—they’ve fallen off a cliff. The title of the report says it all: FDA: Science and Mission At Risk.
The problem, according to the report: a lack of funding. The Coalition for a Stronger FDA, co-chaired by the last three secretaries of Health and Human Services (the department that oversees the FDA), says the FDA needs a 15 percent boost in funding per year for the next five years.
Here are just a few highlights from the report:
- “The Information Technology situation is problematic at best—and at worst it is dangerous.”
- “The FDA has substantial recruitment and retention issues”.
- “Critical data…including valuable clinical trial data…are sequestered in piles and piles of paper documents in large warehouses."
- “The FDA has an inadequate and ineffective program for scientist performance."
- "The FDA has inadequate funding for professional development to ensure that staff maintain scientific competence."
William Hubbard, a former FDA associate commissioner who supports the Coalition for a Stronger FDA, told ABC News that the report stands out because of the "intensity of the feelings" expressed by the subcommittee.
"These people were horrified by what they found," he added.