Agency speakers also discuss quicker inspections and combination drugs Feb. 16-17 at the new Puerto Rico Convention Center.
At Medical Device Puerto Rico, at least three FDA speakers were not shy about explaining that responsibilities for agency employees were increasing despite budget cuts.
The clearest of these messages was delivered in a keynote address by Gary Dykstra, regional food and drug director for the FDA's southeast region. He pulled no punches in describing the federal government's growing financial commitment to homeland security and related issues, presumably at the expense of funding FDA efforts. Dykstra singled out the current administration, saying he hoped change would come with the next presidential election.
At a conference called "Inspection Priorities, Warning Letters & Complaints," the FDA's Joseph Puleo noted that the agency "typically gives U.S. companies a week or two advance notice before coming to a plant for inspection." Of course, this provides a manufacturer time to prepare for the visit, but as Puleo says, "it also benefits the FDA in that it allows them to communicate with the company so that the appropriate plant personnel are on-site for the inspection."
Puleo added that inspectors "like to do an inspection in four or five days, which is considerably quicker than previously. The FDA does this by focusing its inspection on a systems approach rather than spending weeks on specific areas." He earned the audience's appreciation by saying, "That way, you can get the FDA out of your hair for a couple of years."
Combination products was another hot topic that came up during "Regulatory Considerations for Conducting Clinical Trials of Medical Devices," by Elisa Harvey, of the Office of Device Evaluation, Center for Devices and Radiological Health, FDA. She said that regulations apply to all clinical studies, and that clinical trials need to be designed differently depending on the objective and regulatory pathway to market. She recommended visiting the FDA's "device Web site" for moreinformation. Perhaps Harvey's most memorable observation was her prediction that "in 10 years, everything will be a combination product."
--By Jim Butschli, Editor
