'New Use' doesn't mean new leniency

WASHINGTON - Draft FDA guidances on the standards of evidence required for approval of drugs and biologicals, as well as for new uses of existing cancer treatments, should not lead anyone to think that the agency has or intends to lower its requirements for demonstration of efficacy, according to senior FDA officials and advisory panel members.

By contrast, in comments filed with the agency, pharmaceutical and biotechnology industry representatives have registered strong disappointment that the two proposed guidance documents, issued last March, do not break new ground (see A6). In fact, industry comments argue, rather than ease impediments to approving new products, the guidances impose new burdens and give the agency additional powers. (See BioCentury Extra March 14 and BioCentury March 17 for reviews of both "New Use Initiative" documents.) ...