WASHINGTON _ The FDA released a short list ofminor regulatory changes before the Thanksgivingholiday that the biotechnology industry is just beginningto review.
FDA Associate Commissioner for Policy Bill Schultzsaid the changes represent the agency's commitment to"fast drug approval time tables."
According to the FDA's Talk Paper, manufacturers nowwill be permitted to disseminate to health carepractitioners peer-reviewed journal articles and textbookson which the FDA relied to approve a drug that containminor references to off-label uses of approved drugs.
Lisa Raines, vice president of government relations forCambridge, Mass.-based Genzyme Corp. termed FDApolicy change "an extremely narrow proposal that doesnot divert attention away from the fact the agency'sposition on promotional materials is indefensible."
The biotech industry wants discretion to distribute allpromotional materials that advocate off-label uses,beyond those documents submitted as part of the FDAreview process.
Raines said the minor policy change again highlights that"FDA's policy on promotional materials is so restrictiveas to be absurd" and again predicted, as many industrylobbyists have, a fierce debate in Congress on FDAcontrol of promotional materials when it focuses on FDAreform legislation.
The Talk Paper also said that the FDA has issued aguidance document to drug manufacturers which "signalsFDA's willingness to accept a summary report oftoxicology findings based on unaudited, drafttoxicological reports of complete studies."
The FDA document specifies what manufacturing datawill be required before the FDA will accept a drug forinitial investigations in humans. Public comments aresought on the policy changes.
The agency's third initiative, which will be published inthe Federal Register in the first quarter of 1996, seekspublic comments on whether to permit a single-doseinvestigational new drug (IND) application with limiteddata requirements and reduce or eliminate the INDsubmission requirements for individual investigatorsseeking to use products that have been previouslyapproved for advanced human testing.
Carl Feldbaum, president of the Biotechnology IndustryOrganization (BIO), said the Talk Paper "does notcontain a lot of detail, but the tone is positive." He said itmeets BIO's articulated policy goals "to streamline theinvestigational new drug application process and todisseminate peer-reviewed articles." n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.