FDA Field Empowerment: Problems For Industry

The new emphasis at the US Food and Drug Administration will be on clinical studies vs raw data vs summary, Mary Richardson, deputy director of scientific investigations at the Center for Drug Evaluation and Research, told the Food and Drug Law Institute's annual education seminar (see also Marketletter December 19, 1994).

The division will be doing study-oriented and investigator-oriented inspections, and warning letters could be sent to sponsors for not monitoring studies adequately, she told the meeting. until corrections are made, additional subjects cannot be added to ongoing studies, and new studies cannot be started. Ms Richardson expressed concern at company allegations of a lack of communication between FDA field offices and headquarters in terms of inspections, and pledged to discuss the matter with other agency officials.

In trying to hold onto market share in the face of generic competition, brand-name companies are aggressively using all legal and scientific options available, said Peter Safir of Kleinfeld, Kaplan & Becker, but he reminded the conference that there is a fine line between aggressiveness and generic-bashing. Petition and litigation, focusing on scientific issues and legal challenges, are being used by pioneer firms to fend off generics. The issues being raised include challenges to FDA bio-equivalence guidances, legal challenges to the Abbreviated New Drug Application process itself, non-patent exclusivity and the paper NDA process. Generic companies are also using lawsuits to get their products to market, and he warned pioneer manufacturers to ensure their actions are both legal and scientific. Years after the passage of the Waxman-hatch legislation, there are still provisions and interpretations that can trap companies.