FDA Suit Over Regulation of Sleeping Pills Hits Ninth Circuit

(CN) – A Ninth Circuit panel on Thursday entertained arguments over whether to reverse the dismissal of a lawsuit brought by a University of California researcher who claims the Food and Drug Administration’s failure to adequately regulate sleeping pills leads to thousands of deaths annually.

Dr. Daniel Kripke sued the FDA in 2016, claiming the agency failed to respond to his citizen petition within the required 180 days to better regulate hypnotics, which are among the most-prescribed drugs in the country.

Kripke, a researcher at UC San Diego who has published research on sleeping pills for more than four decades, says despite demonstrated harms of using the medication, it is not regulated or tested by the FDA.

A federal judge from the Southern District of California dismissed Kripke’s lawsuit last year, finding the FDA did not unreasonably delay responding.

But on Thursday Kripke’s attorney Gregory Weston of San Diego told Circuit Judges Dorothy Nelson and Morgan Christen and Senior U.S. District Judge Edward Shea of the Eastern District of Washington the case is of “grave importance for the tens of thousands” of Americans who die every year due to complications from taking sleeping pills.

Weston argued Kripke has standing to bring his claims on multiple points, including economic injury, vocational interest and prospective physical injury.

He said Kripke has conducted his own research on sleeping pills – at his own expense – and believes the government is obligated to fund his research and that of other researchers.

Weston also noted Kripke’s public safety concern over vehicle collisions caused by people taking sleeping medication as a reason he has standing to bring the case.

Weston said the FDA has not addressed Kripke’s petition in a reasonable amount of time, noting it has been 32 months since his client’s petition was filed and the FDA has not made any decisions or done any information gathering.

But FDA attorney Ethan Davis told the panel Kripke lacked standing to sue over the delayed petition.

“Granting relief here would stretch standing beyond the breaking point,” Davis said.

Davis argued Kripke only asserts a “generalized interest” based on speculation as to how he could be injured, something Judge Christen pushed back against.

“He is saying loudly and clearly he thinks these drugs are not safe – and he’s in the business. This is his career, this is what he studies and this is the patient population he treats,” Christen said in pondering “it’s hard to imagine … it wouldn’t affect his practice.”

Davis said Kripke filed his lawsuit shortly after the 180-day deadline for the FDA to respond to his petition expired, which the attorney characterized as a reasonable delay. He noted Kripke’s petition was “more complex” than most of the hundreds of other pending petitions filed with the FDA.

But Weston said his client did not expect the FDA to come up with a decision or regulation in 180 days, so much as take “first steps” to regulate sleeping pills.

“We allege the petition was being completely ignored,” Weston said.

The panel did not indicate how it would rule.


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