Date: Jan 26, 2011
Keller and Heckman Partner Frederick A. Stearns was quoted in a January 2011 Anesthesiology News article titled, "FDA Grants Appeal To Reconsider Automated Propofol Sedation System." The article explains that the U.S. Food and Drug Administration (FDA) will appoint a new independent advisory panel to reevaluate an automated propofol sedation system, which the agency previously had declined to approve. The reevaluate is in response to an appeal from the system's manufacturer, Ethicon Endo-Surgery.
Noting that FDA has granted this type of appeal only once before, more than 20 years ago, Anesthesiology News quotes Mr. Stearns, "It is uncommon for a company to use the appeals process [to contest the FDA's decision], but it's even more uncommon for them to be successful." He then explains in the article that the decision essentially means that the commissioner's office "acknowledged the [FDA's] Center for Devices did not review the data correctly." Mr. Stearns, who the article points out specializes in legal issues involving the regulation of drugs and medical devices, adds, "It would be surprising if, on the second time around, the company still does not get approved."