Apr 21, 2008 comment on the food and drug administrations fdas draft guidance for industry on good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses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. Fdas good reprint practices guidance pros and cons of the proposed rules for distribution of offlabel information medical journals may soon become the pharmaceutical industrys newest physician marketing partner. The information on this page is current as of april 1 2019. Fda2008d0053 guidance for industry on good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on. This guidance describes the food and drug administrations fdas or agencys current. Fda revisits policies on distributing scientific publications latham. Good reprint practices for the distribution of medical journal articles and medical or. How do you weigh negative fda feedback in pre2018 opdpddmac comments. Apr 08, 2008 the department urges fda either not to promulgate a guidance for industry concerning good reprint practices, leaving the language of the food, drug and cosmetic act to speak for itself, or impose meaningful restrictions on the nature and validity of the articles that manufacturers may disseminate without fear of running afoul of legal limits. Guidance for industry good reprint practices for the distribution of medical journal.
Distributing scientific and medical publications on risk. This guidance is intended to describe the food and drug administrations fda or agency current thinking regarding good reprint practices. Fda revisits rules on drug and device communication. Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on. Testimony of coleen klasmeier on behalf of the medical.
The new guidance document, when finalized, will repeal and replace the 2009 reprint 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scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices this draft guidance document represents the food and drug administrations current thinking on this topic. As a result, last friday, fda issued a new draft guidance revising the 2009 document to expand fdas guidance on good reprint practices to apply to medical reference texts and cpgs. Department of health and human services food and drug administration office of the commissioner, office of policy. Fda issues final guidance on good reprint practices. Gdps are enforced by regulatory agencies such as the fda, tga, emea, health canada or who. Information may also be provided consistent with fdas good reprint practices. Search for fda guidance documents distributing scientific and medical publications on risk information for approved prescription drugs and biological productsrecommended practices regulatory. Fda, memorandum, public health interests and first amendment considerations related to manufacturer communications regarding unapproved uses of approved or cleared medical products january 2017. Fdas guidance documents do not establish legally enforceable rights or responsibilities. The department urges fda either not to promulgate a guidance for industry concerning good reprint practices, leaving the language of the food, drug and cosmetic act to speak for itself, or impose meaningful restrictions on the nature and validity of the articles that manufacturers may disseminate without fear of running afoul of legal limits. Apr 01, 2019 the information on this page is current as of april 1 2019. Fda s good reprint practices guidance pros and cons of the proposed rules for distribution of offlabel information by john mack medical journals may soon become the pharmaceutical industrys newest physician marketing partner. Fda, guidance for industrygood reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and.
Fda finalizes guidance on distribution of reprints. Firms interested in making such communications should refer to existing draft and final guidance documents on offlabel promotion and risk information. Some fda guidance documents on this list are indicated as open for comment. Good guidance practices ggps are fda s policies and procedures for developing, issuing, and using guidance documents.
Fda is revising its 2009 guidance on good reprint practices to clarify the. Fda 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 jan. On january 12, 2009, the food and drug administration fda published a guidance document, 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 the good reprint practices guidance. Fda expands and clarifies its good reprint practices guidance march 2, 2014.
Fda s draft guidance on responding to unsolicited requests for offlabel information about prescription drugs and medical devices. Commercial speech issues remain after fda guidance law360. Draft guidance for industry on good reprint practices for the. Good reprint practices fda recognizes public health and policy justification for dissemination of truthful and nonmisleading scientific and medical information fdas legal authority to determine that dissemination of materials constitute promotion of new use. Margolis on january, 2009, the food and drug administration fda issued its longawaited final guidance titled good reprint practice for the distribution of medical journal articles and medical or scientific. Good reprint practices for the distribution for medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. Comments of the new york state department of health. Guidance for industry good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of. Bio comments on good reprint practices, fda docket 2008d0053, april 21 2008, p.
Fda has proposed new rules to guide the pharmaceutical industry in promot ing offlabel uses of drugs. 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 jan. In the federal register of february 20, 2008, fda announced the availability of a draft guidance for industry entitled 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. Fda seeks public comment on revised draft guidance for. Fda, draft guidance, drug and device manufacturer communications with payors, formulary committees, and similar entities questions and answers january 2017. Instead, guidances describe the agencys current thinking on a topic and should be viewed only as. Fda revisits policies on distributing scientific publications in new draft guidance, fda. The nature of the guidance and limits on its proscriptive. Distributing scientific and medical publications on unapproved new uses recommended practices revised guidance february 2014. Further, fda reiterates this position in the recently issued draft guidance on responding to unsolicited requests. Filter by fda organization, center for drug evaluation and research, for all the guidances related to drugs. Distributing scientific and medical publications on unapproved new uses recommended practices. Good reprint practices for the distribution of medical. As it did in the 2009 good reprint practices guidance and in prior law, fda does acknowledge in the new reprint guidance that the public health may benefit when health care professionals receive truthful and nonmisleading scientific or medical publications on unapproved new uses, and that fda recognizes the value to health care.
As it did in the 2009 good reprint practices guidance and in prior law, fda does acknowledge in the new reprint guidance that the public health may benefit when health care professionals receive truthful and nonmisleading scientific or medical publications on unapproved new. Substantively, the draft guidance includes all of the principles and recommendations contained within the existing 2009 reprint guidance. Fda home page search fda site fda az index contact fda guidance for industry 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 u. How do you consider dataclaims removed by da in label negotiations. Fda s guidance documents do not establish legally enforceable rights or responsibilities. Fda emphasizes that all distributed materials should not. Distributing scientific and medical publications on.
Fda issues draft guidance pertaining to good reprint practices for offlabel uses guidance will replace the safe harbor that was provided under the fda modernization act. Overview of safe harbors and regulatory compliance and the. Consistent with the provisions in section 401, among other things, the 2009 guidance provided fdas recommendations on the type of articles or publications that were appropriate for dissemination and the manner in which the. Part 99, on september 30, 2006, fda issued the 2009 guidance on good reprint practices. The fdas new guidance for offlabel promotion is only a start. Todays federal register announces fdas issuance of a final guidance for industry on 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. On january 12, the fda finalized its good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved.
Testimony of coleen klasmeier on behalf of the medical information working group one page summary. Fda issues draft guidance pertaining to good reprint. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Fact sheet on an fda report identifying best practices for making the agencys guidance development processes more transparent and efficient. Compliance with the food and drug administrations glp, or good laboratory practices, regulations 21 cfr part 58, as well as gmp regulations for drugs and medical devices 21 cfr part s 211 and 820 requires the use of good documentation practices. Guidancecomplianceregulatoryinformationguidancesucm070072.
The updated draft guidance serves to illustrate how manufacturers should avoid creating false or misleading or otherwise violative information, even under the guise of professional education. Good reprint practices fda recognizes public health and policy justification for dissemination of truthful and nonmisleading scientific and medical information fdas legal authority to determine that dissemination of materials constitute promotion of new use has not changed recommends good reprint practices. Jan 27, 2009 on january 12, 2009, the food and drug administration fda published a guidance document, 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 the good reprint practices guidance. Fdas good reprint practices guidance pros and cons of the proposed rules for distribution of offlabel information by john mack medical journals may soon become the pharmaceutical industrys newest physician marketing partner. Advamed guiding principles for product communications. Fda issues a final guidance on good reprint practices the us food and drug administration fda issued final guidelines on january, 2009, setting forth good reprint practices for drug and medical device manufacturers reprint guidance. Food and drugs part 58good laboratory practice for. He thinks the fdas existing january 2009 guidance for industry on good reprint practices weakens the u.
Fda started to develop the concepts for good reprint practices in 1997 in response to fdama. In the form of an unabridged reprint, copy of an article, or referenced publication. Fda issues guidance document regarding good reprint. Fda home page search fda site fda az index contact fda. This guidance is intended to describe the food and drug administrations fda or agency current thinking regarding good reprint practices with regard to the distribution by a. Fda issues final good reprint practices guidance lexology. Margolis on january, 2009, the food and drug administration fda issued its longawaited final guidance titled good reprint practice for the distribution of medical journal. The guidance updates the draft guidance issued in january 2009 entitled, good reprint practices for the. Food and drug administration fda announced the availability of a revised draft guidance document titled. Importantly, such information must be truthful, nonmisleading, and consistent with the weight of credible evidence on an offlabel use of the product. Draft guidance for industry on good reprint practices for. As it did in the 2009 good reprint practices guidance and in prior law, fda does acknowledge in the new reprint guidance that the public health may benefit when health care professionals receive truthful and nonmisleading scientific or medical publications on unapproved new uses, and that fda recognizes the value to. Specific data types interim analysis data subset data reprints currently disseminated under good reprint practices guidance use of disclaimers.
Good reprint practices guidance guidance for industry, 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. Fda updates reprint guidance, reiterates narrowness of off. Guidance for industry 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 u. Fda made available for comment draft guidance titled 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 the draft reprint guidance. Food and drug administration fda issued its final good reprint practices guidance regarding the distribution of medical or scientific journal articles and. Fdas good reprint practices guidance pharma marketing. Fda has also issued guidance documents to describe some of the circumstances when it would not consider a manufacturers distribution of reprints, clinical practice guidelines, or reference texts regarding unapproved uses of approved drugs to be evidence of intended use andor false or misleading. Fda expands and clarifies its good reprint practices guidance. Distributing scientific and medical publications on unapproved new uses recommended practices the revised draft reprint guidance. Commercial speech issues remain after fda guidance.
Good guidance practices ggps are fda s policies and procedures for developing, issuing, and using. Fda issues final guidance on good reprint practices january 21, 2009, covington ealert. Whats old is new again this article first appeared in bloomberg law reportshealth law, may 2009. On friday, february 15, 2008 on the eve of the threeday presidents day. Fda issues draft guidance on communications that are. Advamed members support continued dialogue with the fda to establish clear. Guidance for industry good reprint practices for the. This guidance is intended to describe the food and drug administration s fda or agency current thinking regarding good reprint practices with regard to the distribution by a. Federal register guidance for industry on good reprint.
The fda also gives examples of publications that, in its view, are not scientifically rigorous enough andor independent publications which, in its view, would not be consistent with good reprint practices. January 2009 final guidance good reprint practices for the distribution of medical journal articles and medical or. Distributing scientific and medical publications on unapproved new uses recommended practices revised guidance march. Good reprint practices guidance guidance for industry, 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 2009 establishes parameters for disseminating journal articles and textbooks. 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. The guidance is a revision of a 2009 draft guidance, good reprint practices for the distribution of medical journal articles and medical or. Fdas good reprint practices guidance pharma marketing network. Good reprint practices for the distribution of medical journal.
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