JOURNAL REPRINTS WITH "REFERENCE TO" UNAPPROVED USES WOULD BE ALLOWED UNDER FDA PROMOTION REFORM; TEXTBOOK DISSEMINATION OKAY IF OFF-LABEL USE NOT "HIGHLIGHTED"

FDA will allow companies to disseminate journal reprints of studies used to support an approved indication that include incidental references to off-label uses, the agency said Nov. 21. "FDA has determined that certain peer-reviewed journal reports upon which FDA relied for approval of a product may be distributed even if they contain information (e.g., reference to unapproved uses) that is inconsistent with the FDA-approved labeling for the product," an agency "Talk Paper" on the reforms states.

The agency's prohibition on dissemination of journal reprints dealing with off-label uses has been a target of industry and congressional proposals for FDA reform. The Nov. 21 announcement represents an acknowledgment by FDA of the issue but reiterates that the agency is not willing to go as far as permitting reprints primarily on unapproved uses. Sen. Kassebaum's (R-Kan.) reform bill, for example, would allow distribution of peer-reviewed articles that primarily focus on unapproved uses with a disclaimer that the off-label uses have not been approved by FDA.

FDA also announced that it will allow companies to distribute independently- produced textbooks that do not focus on a company's specific drug, biologic, or medical device product or unapproved use.

"Although drug and device companies are not permitted to promote unapproved uses of FDA-approved products, FDA has determined that distribution of certain textbooks that do not highlight unapproved uses should be permitted," the agency said. FDA will stipulate that no product information should be displayed on or in the book.

The textbook dissemination issue arose in early 1991 when FDA cited Bristol-Myers Squibb's controlled circulation publication "Oncology Commentary `90" as a misleading promotion. Under a settlement agreement, FDA began to preclear Bristol's oncology promotions, which led to discussions between the agency and Bristol over which of its sponsored publications would not be considered "promotional." The Bristol oncology negotiations foreshadowed some of the agency's concerns in its draft regulation of CME.

The announcement of the promotional reforms preceded by one week a scheduled hearing of Rep. Barton's Commerce/Oversight Subcommittee on FDA "censorship" ("The Pink Sheet" Nov. 20, T&G-5). That hearing, however, has been canceled.

FDA's proposed reforms on journal reprint and textbook dissemination will be detailed in draft guidances for industry to be issued shortly by the agency. The draft guidances will be made available for public comment in a Federal Register notice that is expected to appear the week of Nov. 27.

The FDA reform proposals, which also include clarifications of IND submission requirements and changes in manufacturing reports, are the second round of initiatives to be announced in November. On Nov. 9, Vice President Gore and FDA Commissioner Kessler announced reforms repealing preclearance of biologics advertising and eliminating the Establishment License Application and lot-release testing for "well-characterized" products ("The Pink Sheet" Nov. 13, p. 3).