As EPA gets ready to approve the registration of an insect repellant for food packaging, another government agency, the Food and Drug Administration (FDA), appears intent on dictating mandatory changes in the format of prescription drug labeling. That has the prescription drug industry alarmed. The proposed regulations, implementing the FDA Modernization Act of 1997, would, said FDA, "reorder the content areas of the labeling, add an introductory section of highlights and an index, and institute an identification system to enhance accessibility to detailed information." FDA said it would issue a proposed regulation by September. A mandatory labeling change would cost the pharmaceutical industry an estimated $100 million, says Jeff Truitt, spokesman for the Pharmaceutical Manufacturers Assn. FDA, he claims, appears to be going beyond what Congress intended in the law. "At the time the act was passed, our understanding was that it [labeling changes] would be voluntary, flexible, and up to companies to decide how to proceed," Truitt says. "What we're now getting from FDA is that it will be mandatory and done in a certain way."
Packagers tell insects: 'Stop bugging us!' (sidebar)
Prescription drug labeling changes
May 31, 1998