Attorney Blasts CDRH for 8,000-day Petition Delays

Attorney and data scientist Bradley Thompson (Epstein Becker Green) says FDA shouldn’t be able to continue refusing to respond to citizen petitions, sometimes for years and years. In an online post, Thompson analyzes the amount of time it takes CDRH to reach final decisions on citizen petitions.

Thompson says his ability to answer questions he had about CDRH responses to petitions was hindered by the fact that the Center “is violating the law in its reporting of the data.” He points out that agency regulations require that the Division of Dockets Management maintain a chronological list of each petition that is filed with the docket number, the date the petition was filed by the Division of Dockets Management, the name of the petitioner, the subject matter involved, and the disposition of the petition. “But CDRH does not always comply,” he writes. “Their list … includes items one through four but not always item five. To get item five you need to follow the link provided and sometimes in the header FDA indicates the outcome, but frequently they do not and you’re forced to read the agency’s decision to figure out the outcome. I had to read over 120 agency letters.”

Thompson says that FDA “takes an enormous amount of time to resolve petitions, well past expressed regulations the agency adopted” that call for a response within 180 days.

“FDA is just sitting on petitions,” he says. “Not just a little bit past 180 days. Think of the order of magnitude. Nine hundred days would be way past 180, five times beyond. But we are talking almost 45 times that. We’re talking about over 8,000 days.”

He notes it is no secret that the agency does a poor job reviewing citizen petitions, citing among other things a 7/1998 report from the HHS Inspector General.

According to Thompson, the FDA medical device regulations say that manufacturers shall ensure that “all complaints are processed in a uniform and timely manner.” He says it appears to be a case of companies being told to do what FDA says, but not what it does.

“I'm trying to understand FDA’s actions,” Thompson writes. “Citizen petitions deal with topics of great concern to citizens, and often have significant public health implications as well as issues of legal compliance. The petitions often have merit as reflected in the fact that FDA does grant many of them, albeit thousands of days later. FDA has a regulation on its books that says that it will respond to these within 180 days. But FDA routinely blows by those deadlines not just by a factor of almost five, but by a factor of almost 45. And at the same time, FDA brings enforcement actions against companies that fail to review and report certain incidents within 30 days.

“FDA’s excuse typically is based on resources, but how often does FDA accept an excuse of too few resources from a company regarding its compliance? Further, let's think about the resource issue. CDRH received just over 300 petitions in 23 years. That's just over 13 petitions a year, hardly overwhelming. FDA’s quality system is completely broken.”

Thompson concludes that the situation he has described cannot continue. “The government has studied the issue before and made recommendations, only for those recommendations to be utterly ignored by FDA. This is not a case where FDA is in a difficult position, i.e., given a mandate but without funding. In the case of CDRH, we are talking about an average of 13 petitions a year, hardly an avalanche, and FDA data shows that the agency has no problem quickly denying some portion of those because they don’t comply with the requirements of a citizen’s petition. The work to be done is entirely manageable. This is simply a case of FDA deciding it doesn’t want to do something, for reasons that it doesn’t want to articulate publicly, and the agency leadership failing to hold itself accountable.”