FDA Guidance on Distribution of Articles

January 13, 2009 at 8:22 pm Leave a comment

The FDA has released it guidance on the distribution of scientific articles that contain information about unapproved uses of drugs. From time to time CME providers may be asked to be a party to this kind of activity. Better read up on the guidance. Click here for the link to the entire agency statement.

Here are the rules.

Agency Recommendations for Good Reprint Practices

Scientific and medical information that concerns the safety or effectiveness of an approved drug or approved or cleared medical device for an unapproved new use that is not included in the product’s approved labeling or statement of intended uses (including unapproved new uses of approved drugs and approved or cleared devices) is often published in journal articles or reference publications. These publications are often distributed by manufacturers to healthcare professionals or healthcare entities. When a manufacturer disseminates such medical and scientific information, FDA recommends that the following principles of “Good Reprint Practices” be followed.

A. Types of Reprints/Articles/Reference Publications

A scientific or medical journal article that is distributed should:

* be published by an organization that has an editorial board that uses experts who have demonstrated expertise in the subject of the article under review by the organization and who are independent of the organization to review and objectively select, reject, or provide comments about proposed articles; and that has a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors, contributors, or editors associated with the journal or organization;
* be peer-reviewed and published in accordance with the peer-review procedures of the organization; and
* not be in the form of a special supplement or publication that has been funded in whole or in part by one or more of the manufacturers of the product that is the subject of the article.

A scientific or medical reference publication that is distributed should not be:

* primarily distributed by a drug or device manufacturer, but should be generally available in bookstores or other independent distribution channels (e.g. subscription, Internet) where medical textbooks or periodicals are sold;
* written, edited, excerpted, or published specifically for, or at the request of, a drug or device manufacturer; or
* edited or significantly influenced by a drug or device manufacturer or any individuals having a financial relationship with the manufacturer.

The information contained in the scientific or medical journal article or reference publication should address adequate and well-controlled clinical investigations that are considered scientifically sound by experts with scientific training and experience to evaluate the safety or effectiveness of the drug or device. These can include historically controlled studies, pharmacokinetic (PK) and pharmacodynamic (PD) studies, and meta-analyses if they are testing a specific clinical hypothesis.

The information must not:

* be false or misleading. For example, a distributed journal article or reference text should not be characterized as definitive or representative of the weight of credible evidence derived from adequate and well-controlled clinical investigations if it is inconsistent with that weight of credible evidence or a significant number of other studies contradict the article or reference text’s conclusions; should not have been withdrawn by the journal or disclaimed by the author; and should not discuss a clinical investigation where FDA has previously informed the company that the clinical investigation is not adequate and well-controlled; or
* pose a significant risk to the public health, if relied upon.

The following publications are examples of publications that would not be considered consistent with the “Good Reprint Practices” outlined in this guidance:

* letters to the editor;
* abstracts of a publication;
* reports of Phase 1 trials in healthy subjects; or
* reference publications that contain little or no substantive discussion of the relevant investigation or data.

B. Manner in which to Disseminate Scientific and Medical Information

Scientific or medical information that is distributed should:

* be in the form of an unabridged reprint, copy of an article, or reference publication;
* not be marked, highlighted, summarized, or characterized by the manufacturer in any way (except to provide the accompanying disclosures discussed in this section);
* be accompanied by the approved labeling for the drug or medical device;
* be accompanied, when such information exists, by a comprehensive bibliography of publications discussing adequate and well-controlled clinical studies published in medical journals or medical or scientific texts about the use of the drug or medical device covered by the information disseminated (unless the information already includes such a bibliography);
* be disseminated with a representative publication, when such information exists, that reaches contrary or different conclusions regarding the unapproved use; especially those in cases where the conclusions of articles or texts to be disseminated have been specifically called into question by another published article(s) or text(s); and
* be distributed separately from information that is promotional in nature. For example, if a sales representative delivers a reprint to a physician in his office, the reprint should not be physically attached to any promotional material the sales representative uses or delivers during the office visit and should not be the subject of discussion between the sales representative and the physician during the sales visit. Similarly, while reprints may be distributed at medical or scientific conferences in settings appropriate for scientific exchange, reprints should not be distributed in promotional exhibit halls or during promotional speakers’ programs.

The journal reprint or reference publication should be accompanied by a prominently displayed and permanently affixed statement disclosing:

* that the uses described in the information have not been approved or cleared by FDA, as applicable to the described drug or medical device;
* the manufacturer’s interest in the drug or medical device that is the subject of the journal reprint or reference text;
* any author known to the manufacturer as having a financial interest in the product or manufacturer or who is receiving compensation from the manufacturer, along with the affiliation of the author, to the extent known by the manufacturer, and the nature and amount of any such financial interest of the author or compensation received by the author from the manufacturer;
* any person known to the manufacturer who has provided funding for the study; and
* all significant risks or safety concerns known to the manufacturer concerning the unapproved use that are not discussed in the journal article or reference text.

V. Summary

FDA recognizes that the public health can be served when health care professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products. Accordingly, if a manufacturer follows the recommendations described in Section IV of this guidance, FDA does not intend to consider the distribution of such medical and scientific information in accordance with the recommendations in this guidance as establishing intent that the product be used for an unapproved new use. However, if a manufacturer engages in other conduct that unlawfully promotes an unapproved use of a medical product — whether or not the manufacturer also engages in conduct in conformance with the recommendations in this guidance — such other conduct may result in enforcement action.


Entry filed under: CME, CME Issues, Continuing Medical Education.

Andragogy and PI CME Be Careful When Addressing Uses for Unapproved Drugs: Lilly Gets Fined

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