Orange County

FDA Bash: Local makers of medical devices aren’t satisfied with results of the federal Food and Drug Administration’s effort last year to reform itself. Manufacturing executives will meet Wednesday at the Hyatt Regency Irvine to consider mounting their own lobbying campaign to inform congressional representatives about their concerns. Though the FDA won industry kudos for speeding up approvals of product applications last year, executives say that’s hardly enough. Among other things, they worry that the agency’s attempt to regulate tobacco will deflect regulators’ attention from their industry. They also object to FDA demands that manufacturers prove the cost-effectiveness of new products. James R. Phelps, a lawyer who represents companies dealing with the FDA, is scheduled to speak at the session. Phelps, a principal at the Irvine-based Hyman, Phelps & McNamara law firm, previously held positions as a trial lawyer for the agency, as an assistant U.S. attorney for the District of Columbia and as general counsel of drug giant G.D. Searle & Co. The breakfast meeting begins at 7:30 a.m.