To me, it looks like a very clever marketing story.
The medication has been cited as a so-called "suspect" medication in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market, as highlighted in a recent CNN report.
The FDA told CNN this week that the agency had already begun conducting a new evaluation of the medication when Gottlieb was questioned about it at the hearing. The agency said the review had started several weeks ago.
Rosa DeLauro, a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA. How many people, quite frankly, have to die?
Why does the industry always take precedence over public health and safety?
But the FDA uses the information to monitor potential issues with a drug and can take action as needed: In rare cases, the agency can even pull a drug off the market. But physicians, researchers and other medical experts told CNN that the high number of reports deserved a closer look to determine whether they were related to the drug.
They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective. What should we investigate next? But the FDA ruled that the potential benefits outweighed the risks, agreeing with an advisory committee that cited a lack of safe alternatives and the pleas from family members who claimed the drug was already helping or could help their loved ones.
At that advisory committee meeting two years ago, one woman said that her grandmother had been part of the clinical trials for the drug and that Nuplazid had been life-changing.
Her hallucinations reduced, and she better understood what was real and what was imaginary. During the first 10 months Nuplazid was on the market, deaths were reported to the FDA in which Nuplazid was a "suspect" medication, according to an analysis conducted by the Institute for Safe Medication Practices.
FDA data now show that the number of reported deaths has risen to more than In more than 1, reports, patients continued to experience hallucinations while on Nuplazid.
Some said they had not yet reported these experiences to the drugmaker or the FDA. While the FDA has long been criticized for being too slow to approve drugs, DeLauro seized on its push to streamline the process, lambasting the agency for putting industry interests and efficiency above public health and safety.
DeLauro described the number of adverse events and deaths as "staggering" and "unprecedented. Commissioner Gottlieb told the committee that the FDA is careful about the decisions it makes and that there may be a higher tolerance for risk in situations where there is an unmet medical need, "so long as the patient is properly informed of what those risks are.
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