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.
The report found the agency’s computer system, which tracks hazardous
foods and drugs, is so antiquated, it’s constantly breaking down.
"Imagine having an e-mail system so old, they have to bring technicians
out of retirement because current technicians have never seen equipment
that old,” said Hubbard.
Many front-line employees don’t even have a computer. Inspectors must
write urgent reports by hand, which often end up lost in huge
warehouses. The report does not blame the FDA but rather Congress, for
continually cutting the agency’s budget while asking it to assume more
and more responsibility.
A leading FDA critic in Congress, Rep. Rosa DeLauro, said, "The essence
is, send me a plan, ask for money, and we’ll consider it. But they
never ask for more money or authority."
The report blames Congress for not funding the FDA. But DeLauro seems
to be suggesting that the FDA itself has been less than proactive in
demanding the funds it needs.
Why would the agency be shy?
In recent years, not everyone in the Bush administration has been
enthusiastic about having the FDA do its job. In 2001 Dan Troy became
the agency’s chief counsel. A Bush appointee, Troy had been a longtime
foe of FDA regulation. Just months before joining the agency, he had
represented Pfizer in a battle with regulators. A U.S. News & World
Report headline summed up his career change: “Mr. Outside Moves Inside: Daniel Troy Fought the FDA for Years; Now He’s Helping to Run It.”
During the first two years of the Bush administration, Troy operated in
a power vacuum. The FDA had no permanent commissioner and “while the
White House and Congress publicly argued over who should lead the
agency it was being quietly transformed by appointees such as Troy, who
needed no congressional confirmation,” The Boston Globe observed in
December 2002. U.S. News corroborated the report, saying that Troy
“operated as the de facto head of the FDA” between September of 2001
and November of 2002. During that time, the magazine added, Troy held
“at least 50” closed-door meetings with representatives of drug
companies and others regulated by the FDA. Troy resigned his FDA post
without explanation on November 16, 2004.
In 2002, while Troy was running the agency, it looked as if Alistair
Wood, a respected clinical pharmacologist at Vanderbilt University, was
close to being nominated as FDA chairman. But some industry
executives—along with some members of the Wall Street Journal’s
editorial board—objected. When Senator Bill Frist was asked why Wood
was dropped from consideration for the top post, he summed up the
opposition: “There was a great deal of concern that he put too much
emphasis on safety.”
Since then, drug recalls, failed defibrillators, and questions about
many other products that the FDA has approved suggest that it needs the
resources to put a new “emphasis on safety.”