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Generic drug for xalacom arker testing." But the company will also be on the hook to defend itself against lawsuits by some physicians who don't like the way their medications were deemed to be a medical necessity. A federal advisory panel made up of experts who study clinical-trial oversight recommended in early 2016 that the FDA not approve drug for "use in conditions which it is not indicated or where there are inadequate data to support an indication." "We feel that this is an important product for all of the indications it is being used for," says Dr. Josephine H. Zlotkin, director of FDA's Center for Drug Evaluation and Research. "There are not adequate data to support the indication in most cases, and we continue to have concerns in terms of the safety profile." But the FDA is also weighing a change in its guidance on what qualifies as an "immediate medical necessity" — a condition that, for example, makes a drug necessary to alleviate the symptoms of a particular disorder, or serious condition that, if left undetected or untreated, would otherwise cause a person's life to be shortened. The FDA already has issued "regulatory actions" that allow physicians to use the product when such necessity doesn't apply — as prescribing it in cases where they can't find an FDA-approved treatment. "The new guidance, that was proposed in October, suggests that it's not necessary for a prescription this to be used," says Richard Green, a professor of law at George Washington University School. "So the question becomes, what do you want from the FDA to make sure that the products are available?" If the FDA decides to revise its labeling and prescribing guidelines, Zlotkin says, that will trigger a public comment period. "We've said what our intent is in that case. Klonopin in uk We will address those points in the public comment period." A spokeswoman for Zocor notes that the product is effective and has many other uses. "There is no indication that the product is not medically necessary for all patients," she says. "This product is an important step forward in the care of patients who suffer from sleep apnea — and who are unable to sleep during the rest of their lives. Zocor has an extensive supply of the product and does not anticipate an increase in demand at this time." The FDA declined to say why it did not approve Zocor earlier. The only drug company spokesman who spoke to STAT on Wednesday evening did not address the discrepancy between Zocor's approval and the new label. "The product is one of the only options for treatment of individuals with excessive daytime sleepiness and is approved by the FDA for this indication," spokesman says in an e-mailed statement. The agency is also considering a change to its labeling for the device — a so-called sleep monitor that measures a person's heart rate. The industry has said since 2013 that it is not necessary to use the device diagnose condition, but doctors still use it to monitor patients' sleep patterns. The FDA has received more than 1,300 comments asking the agency to require device be used diagnose the condition. "I have a hard time seeing where the data is there to make this a medical necessity," says Dr. Michael H. Czeisler, chief scientific officer of the Sleep Research Society, which promotes medicine. "This seems to be an example of overreach. They're putting something in people that they're not sure if it is appropriate, and that's the problem." Czeisler points out that the condition does not have an accepted medical definition. "If you were to do an objective autopsy of the heart, you cannot distinguish it from a normal heart," he says. He points out that the sleep-monitor devices monitor heart rate have been around for decades, and the FDA has allowed them in place for a number of years. "This is the first time they're coming into the marketplace and asking for something new," he says. Czeisler says more than a few physicians in particular have been confused by the FDA's guidance, particularly when agency makes vague recommendations about what qualifies as a medical necessity. "If there are too many different definitions, it's hard to follow the FDA guidance," he says. Zocor's CEO, Thomas E. Epps, says the company is not worried about the FDA's decision not to approve the device for sleep apnea. "The is designed for patients with excessive daytime sleepiness who cannot sleep at night to help prevent falls and keep them safe," Epps tells STAT. "The company's goal has always been to provide safe and effective treatments, not necessarily approve a product." Zocor's approval is one of many that could affect the company, which makes a sleep monitoring device, or products that could be prescribed. For example: — Novartis is developing a sleep-monitor that measures.

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