Johnson & Johnson Medical Device Rejected by FDA

01 Mar

Johnson & Johnson is at odds with the Food & Drug Administration over the government agency’s rejection of the company’s medical device which administers a propofol-containing drug. Sedasys, which must be administered by an anesthesiologist, is a medical device that uses a mild sedative during routine medical tests for patients.
After the FDA rejected Johnson & Johnson’s request for approval, the agency requested more data involving anesthesiologists in the control group. According to the Wall Street Journal, the FDA said that it asked Johnson & Johnson for the information before the trial began, something that Johnson & Johnson denies.
"We did everything that we were asked to do," says Mike Gustafson, who oversees the Sedasys program at J&J’s Ethicon Endo-Surgery unit.
The percentage of applications for new devices to be approved by the FDA without delay dropped to 56 percent in 2009 from 74 percent five years previous. Companies pulled 17 percent of applications for new versions of devices in 2009, which was up from nine percent five years earlier. According to AdvaMed, a trade group for the medical-device industry, this was sometimes due to the fact that the FDA sought more information.
"It’s never been as bad as this," says David Nexon, senior executive vice president at AdvaMed.

People in the business community have criticized the FDA for changing their requirements in the middle of the approval process. This is not disputed by the government agency, which says that it does so due to the evolution of scientific findings in the years of the approval process, which may bring to light new questions.

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