Professor Appeals Case Over Sleeping-Pill Regulations

SAN DIEGO (CN) – A University of California professor who researches sleeping pills has asked the Ninth Circuit to review the dismissal of his lawsuit claiming the Food and Drug Administration does a poor job regulating sleeping pills.

Dr. Daniel Kripke sued the FDA, U.S. Department of Health and Human Services and the U.S. Center for Drug Evaluation and Research last year, claiming the most-prescribed drugs in the nation cause thousands of deaths a year and are probably “at least a causal co-factor” in as many as 300,000 deaths annually.

Kripke, a psychiatry professor at UC San Diego, has conducted and published extensive research into the dangers associated with sleeping drugs over his 40-year career.

The professor said 33 of the 34 studies he published on the risks associated with hypnotics found the drugs can kill by slowing a patient’s breathing rate. Other studies show the hypnotics are associated with depression and suicide, increased risk of cancer and serious and potentially lethal illnesses such as pneumonia, liver infections and asthma exacerbation.

Kripke also says the drugs contribute to dangerous falls and hip fractures in elderly patients and car collisions from impaired driving. He believes hypnotics-related deaths are underreported, as deaths that occur at night are rarely examined via autopsy, especially if other chronic conditions are present.

Before filing his lawsuit last May, Kripke filed a citizen’s petition asking the FDA for placebo-controlled trials, requiring sleeping pill manufacturers to issue “Dear Doctor” letters outlining the risks for patients with long-time sleeping pill use, and other actions.

The FDA responded to Kripke’s petition by stating it was unable to reach a decision because “it raises complex issues requiring extensive review and analysis by agency officials.”

Kripke filed his lawsuit less than a month later, asking the court to compel the FDA to comply with his petition.

U.S. District Judge Marilyn Huff dismissed Kripke’s case for failure to state a claims of agency action unlawfully withheld and agency action unreasonably delayed.

Huff found a FDA response to Kripke’s petition was not unreasonably delayed, noting it responded within the 180-day deadline required by federal law.

“It is entirely unreasonable for plaintiff to assert that the FDA has unreasonably delayed deciding such a complex petition when that petition has only been pending for 15 months and plaintiff added additional material to the petition only five months ago,” Huff wrote.

She also noted the FDA has shown it has begun evaluating Kripke’s petition and the laws that govern the FDA do not require the agency to take action within a certain time frame apart from responding to a petition, which it did.

The same goes for the statutes Kripke said the FDA must comply with, which are “mandatory as to the object to be achieved” but leave the agency with “discretion in deciding how to achieve those goals,” Huff wrote in pointing out the actions are not “demanded by law.”

Kripke appealed the dismissal to the Ninth Circuit on Feb. 7.

Gregory Weston, Kripke’s attorney, said in an interview the goal of the lawsuit and appeal is for the FDA to order more studies of drugs that are widely prescribed and can be ineffective and dangerous for many of the people who take them.

U.S. Department of Justice attorney Monica Groat represents the FDA and did not return a phone request for comment.

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