Blog Post #2: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved

Rosalyn Finlayson

October 4, 2010

Name of Guidance:

Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices

Status of Guidance

Guidance for industry

Date of Guidance

January 2009

Link to the Guidance

http://www.fda.gov/oc/op/goodreprint.html

Target audience

Manufacturers of drugs and medical devices, health care professionals, and editors of medical journals and scientific or medical reference publications

Laws And Regulations Referenced

21 U.S.C. 355 Federal Food, Drug and Cosmetic Act (FD&C Act)

42 U.S.C. 351 Public Health Service Act

Section 410 Food and Drug Administration Modernization Act (FDAMA)

Summary

This guidance provides a brief history of Section 401 of the Food and Drug Administration Modernization Act (FDAMA) and the Federal Food, Drug and Cosmetic (FD&C) Act. Described in FDAMA Section 410 and the FD&C Acts are the conditions under which manufacturers of drugs and medical devices may disseminate information in journal articles and reference publications regarding the unapproved uses of approved drugs and approved or cleared medical devices.

Although FDAMA Section 401 ceased to be effective on September 30, 2006, the FDA still retains legal authority over the distribution of information about unapproved uses. The FDA evaluates whether or not the distribution of medical and scientific information in journals and reference publications is actually a promotion for an unapproved “new use” for approved drugs and approved or cleared medical devices. The FDA determines whether or not such an activity would cause a particular product to be in violation of the FDC act.

In this guidance the FDA provides its current view and recommendations for “Good Reprint Practices” for journals and reference publications that present information about unapproved uses of approved drugs and approved or cleared medical devices.

Rationale

Articles in medical journals and reference publications often publish information discussing the safety or effectiveness of using approved drugs and approved or cleared medical devices for an unapproved use. Unapproved uses are any use of the drug or medical device that is not included in the products labeling or stated as an intended use for the product. Of concern to the FDA is having an approved drug or medical device marketed for an unapproved use. The FDA will classify approved drugs and approved or cleared medical devices as an unapproved new drug or medical device with respect to the new use. If an approved drug or medical device is marketed for an unapproved use that particular drug or medical device is considered misbranded.

The FDA recognizes that it is in the best interest of public health for health care professionals to receive information from medical journal articles and reference publications about unapproved uses that is truthful and not misleading. In addition the FDA acknowledges the value of having new uses for previously approved products and encourages manufacturers of such products to seek approvals and clearances for new uses.

The FDA recommendations in this guidance also serve the purpose of providing manufacturers of drugs and medical devices with guidelines to follow in order to avoid engaging in conduct that unlawfully promotes an unapproved use of a drug or medical device.

Resulting Recommendations

The FDA recommends compliance with the following principles of “Good Reprint Practices” for publications distributing scientific and medical information.

Journal Articles

• Scientific or medical journal articles that are distributed should be published by an organization that has an editorial board. It is recommended that the editorial board of a journal use experts with demonstrated expertise in the subject under review. Editorial boards need to be independent of the organization publishing the journal in order to be able to objectively review, select, reject or provide commentary about proposed articles.

• Recommendations for journal articles state that articles need to be peer-reviewed. Published articles should be in accordance with the peer-review procedures of the organization publishing the journal. The articles published cannot be in the form of a manufacturer funded special supplement to the publication.

Reference Publications

• The primary distributor of a reference publication should not be the manufacturer of the drug or medical device. Distribution of reference publications should be made available to bookstores or other independent distribution channels that sell medical textbooks or periodicals.

• A reference publication should not be written, edited, excerpted or published specifically for or at the request of a drug or device manufacturer. The editor of the reference publication should not have any type of financial connection to a manufacturer of drugs or medical devices. Manufacturers of drugs or medical devices of should not have any type of significant influence over a reference publication.

Information

• Information in journals and reference publications should address well-controlled, scientifically sound clinical investigations of acceptable quality. Experts experienced in pharmacokinetic or pharmacodynamic studies and meta-analyses should appraise the clinical investigations presented in journals and reference publications.

• A manufacturer that has been informed that a clinical investigation of their product was deemed by the FDA to be an inadequate and not well controlled study should not allow that information to be disseminated in journals or reference publications.

• Journal and reference publication information must not be false or misleading.

• Conclusions drawn from a clinical investigation should not be characterized as the only definitive credible evidence if there are existing studies with contradictory conclusions.

• All information presented must not pose a significant risk to public health if the presented information is followed.

The F.D.A. guidance states that letters to the editor, abstracts, phase 1 reports of trials in healthy subjects, and reference publications that contain little or no substantive discussion of the relevant investigation or data would not be considered consistent with “Good Reprint Practices”.

Impact

The recommendations in this guidance serve as a safe guard to ensure that accurate, truthful and non-misleading information about unapproved uses for approved drugs and medical devices is disseminated to health care professionals and other entities concerned with public health. Manufacturers who follow the recommendations in this guidance will not face enforcement action for attempting to establish and promote their product for an unapproved use.