This document contains the criteria that the Coalition for Healthcare Communication supports for dissemination of scientific information by pharmaceutical and device manufacturers, including discussion of off-label uses of their products. Off-label uses are those uses of drugs or devices by healthcare providers that are in addition to the indications for which the products are approved by the Food and Drug Administration (FDA).

The Coalition's position, as set forth in this document, is supported in principle by the decision of the U.S. District Court for the District of Columbia, in the Washington Legal Foundation (WLF) vs. Henney case. In this case, the Court struck down three FDA policy documents and portions of the FDA Modernization Act (FDAMA) that imposed severe restrictions on manufacturers' dissemination of scientific information about their products, a violation of the First Amendment.

These restrictions seriously impeded the dissemination of medical textbooks and reprints of articles from peer-reviewed journals that contained discussion of off-label uses. They also prevented commercial sponsors/grantors of Continuing Medical Education (CME) from suggesting content to CME providers if off-label uses of their products were to be discussed.

While the Court of Appeals reversed portions of the District Court’s order on procedural grounds, we believe the District Court’s opinion sets the current constitutional parameters concerning the dissemination of peer-reviewed journals and medical texts, and CME. In this document, we offer our suggestions to the industry and the agency on this important issue.

The company holding an approved new drug application (NDA) or an approved pre-marketing application (PMA) for a medical device may distribute in any manner to a healthcare provider any independently prepared medical textbook, compendium, or peer-reviewed journal article reprint that includes off-label information about the drug or device, providing that the following requirements are met:

General Requirements        

• The product discussed should have at least one FDA approval in effect. The material should disclose the existence of relevant financial interests or other possible biases between researchers, authors, publishers and the companies.
• The sponsors disseminating texts, references or reprints should include FDA-approved labeling, and must disclose in writing or by sticker that they mention use of a drug or device not approved by FDA.
• Pharmaceutical companies may disseminate such reprints, texts or references to healthcare professionals but should not promote off-label use.
• The material must not be false or misleading.
• Specific product information or promotional material, other than approved labeling, should not be physically appended.

Journal Reprints

• Unabridged, independently produced articles must have originally appeared in bona fide peer-reviewed journals that utilize both an editorial board and experts in the subject of the articles to be reprinted. These experts must review and objectively select, reject, or provide comments about proposed articles. and be independent from the journal. Peer review assures balance, objectivity, independence and scientific rigor with no additional arbitrary restrictions.
• The articles should be published in accordance with the regular peer-review procedures of the journals in which they appear.
• The journals must have a publicly stated policy by which they fully disclose any conflicts of interest, biases, contractual arrangements, or other remuneration among authors, contributors, sponsors, or others concerning articles.

Medical Texts

• The text or reference must be from a bona fide publisher. The publisher and author must be independent of the disseminating company and the final arbiter of what appears in the text. Content should not have been prepared, reviewed, or edited by an employee or a representative of a pharmaceutical or medical device firm.
• Complete chapters of texts or references may be distributed.
• Texts should be generally available for sale in bookstores or through other channels where similar books are distributed, and not primarily by, or limited to, distribution by a drug or device manufacturer.

We believe these criteria respond to the interests of all parties by allowing free scientific exchange while providing responsible protection for the integrity of the material.