Cetero tests done between March 1, 2008 and Aug. 31, 2009 would be accepted only if they were accompanied by an independent data integrity audit.
Analyses done after Sept. 1, 2009 would not require retesting. The FDA said that Cetero had issued a written directive on Sept. 1, 2009, ordering one kind of misconduct to stop, which was why it did not require any action on Cetero Houston studies after that date. According to public documents, however, the agency's inspectors "found continued deficiencies" that persisted into December 2010.
In response to questions, the FDA said the problem period "was subsequently narrowed as more information regarding Cetero's practices became available."
A year after concluding its final agreement with Cetero, the FDA's review is still not finished. "Without the process being public it's hard to know, but it seems that this has been going on for too long," said Kessler, the former FDA chief.
"The process has been long," the FDA said, "because of the number of products involved and our wish to be thorough and accurate in both our requests for and our review of the data."
Cetero's attorney Scheineson said the FDA scaled back its requirements because it finally talked with company officials. He noted that Cetero had tried repeatedly to talk with the FDA before the agency issued its strongly worded July 2011 letter, and that more than 1,000 employees have since lost their jobs.
"If you would get an honest assessment from the leaders of the agency," he said, "I think in retrospect they would have argued that this was overkill here and that they should have had input from the company before essentially going public with that death sentence."
"I'm not sure what is meant by ‘death sentence,'" an FDA spokesperson wrote in response, "but our first priority was and is patient safety and we proceeded to conduct the investigation toward that objective."
'Should I Be Proud of This?'
The FDA's Stone draws little satisfaction from unraveling the problems at Cetero.
There are thousands of bioequivalence studies done every year, he pointed out, with each study generating thousands of pages of paper records. "Do you really think we're going to look at 100 percent of them? We're going to look at maybe 5 percent if we're lucky," he said. "Sometimes 1 percent."
Still, given how often he and other FDA teams had inspected the Houston lab, he thinks regulators should have spotted Cetero's misconduct sooner.
"In hindsight I look back and I'm like, 'Wow, should I be proud of this?'" he said. "It's cool that I was part of it, but it's crap that we didn't catch it five years ago. How could we let this go so long?"
Research assistance for this story was contributed by Nick Stockton, Christine Kelly, Lily Newman, Joss Fong and Sarah Jacoby of the Science, Health, and Environmental Reporting Program at NYU.
From ProPublica.org (find the original story here); reprinted with permission.