Drugs

Professor Sues FDA Over Sleeping Pills

University of California-San Diego emeritus professor Daniel Kripke is suing FDA for not adequately regulating sleeping pills. Courthouse News Service reports that Kripke’s suit says that sleeping pills are among the more prescribed drugs in the country and “are the immediate cause of death of more than 10,000 Americans per year, and possibly as many as 34,000 inadvertent, accidental, or deliberate deaths per year.” He adds that the drugs are probably “at least a causal co-factor” in up to 300,000 deaths each year.

The news service says that Kripke has published research on hypnotic drugs for more than 40 years. He says that 33 or 34 scientific studies of the risks associated with hypnotics found that they can kill by slowing the breathing rate. Other studies indicate that they are associated with depression and suicide, increased risk of cancer, and serious and potentially lethal infections such as pneumonia, liver infections, and asthma exacerbation, he says. He adds that they contribute to dangerous falls and hip fractures in elderly patients and car collisions from impaired driving.

Kripke says he filed a petition 10/26/15 to compel the agency to require manufacturers to perform placebo-controlled trials of hypnotics, issue “Dear Doctor” letters on the risks of long-term use, restrict off-label uses, and include mortality risk information on the drug labels. He says he received a form letter from FDA saying it could not reach a decision in the required 180 days because the issue requires analysis by agency officials. He says that response was statutorily inadequate and violates the Administrative Procedures Act and the Federal Food, Drug, and Cosmetic Act.

His suit asks for a declaratory judgment that the agency’s failure to take action is unlawful and an order compelling it to take the actions requested in the petition and to respond by a court-appointed deadline.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome