In february 2008 the fda released a proposed guidance entitled,good reprint practices. Fda publishes guidance for good manufacturing practices. 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reference publications on unapproved new uses of approved drugs and approved or cleared medical devices the 2009 draft guidance. Pharmaceutical qualitymanufacturing standards cgmp data integrity and compliance with current good manufacturing practice guidance for industry pdf 127kb compounding. Articles that discuss unapproved uses of fdaapproved drugs and devices can contribute. The good reprint practices guidance is the first formal pronouncement of the fdas position relating to the dissemination of offlabel information since the sunset on september 30, 2006 of the provisions in the food and drug administration modernization act that govern the dissemination of enduring materials. Fda should clarify the impact of following the proposed guidance a. York times, the fda had justified this loosening of the rules by claiming they never really enforced the requirements anyway.
But the new guidelines would permit far more dissemination of articles on unapproved uses than was sanctioned under the act, rep. Good guidance practices ggps are fdas policies and procedures for developing, issuing, and using guidance documents. Information may also be provided consistent with fdas good reprint practices. Fda emphasizes that all distributed materials should not. Recent draft guidance on good importer practices gao report on drug safety. Strictly adhering to fda guidance regarding good reprint practices and responses to unsolicited requests for information. Substantively, the draft guidance includes all of the principles and recommendations contained within the existing 2009 reprint guidance. The updated draft guidance serves to illustrate how manufacturers should avoid creating false or misleading or otherwise violative information, even under the guise of professional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. The united states food and drug administrations draft guidance for industry, good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses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.
This guidance describes the food and drug administrations fdas or agencys current. This draft guidance describes the food and drug administrations fdas or agency current thinking on recommended practices for drug manufacturers firms and their representatives to follow if. 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 2009 guidance was intended to 128 provide drug and medical device manufacturers and their representatives with recommendations. We previously reported on fdas issuance of the draft guidance. Fda issues draft guidance pertaining to good reprint. Fda memo does not simplify 1st amendment considerations law360. Further, fda reiterates this position in the recently issued draft guidance on responding to unsolicited requests. Overall reaction positive always good to have clarity in a gray area 2.
Fda set to tighten guidelines on industry dissemination of. This list is being published under fda s good guidance practices ggps. For years, the fda has taken the position that it is a violation of the fdca for a regulated manufacturer to promote an unapproved or offlabel use for an fda approved product. Good reprint practices for the distribution of medical journal. Guidance for industry on good reprint practices for the distribution. The food and drug administration fda is publishing a comprehensive list of all guidance documents currently in use at the agency. Bio comments on good reprint practices, fda docket 2008d0053, april 21 2008, p.
Mar 03, 2014 this revises the fdas 2009 draft guidance document on the subject, which was titled. Fda memo does not simplify 1st amendment considerations. May 04, 2009 in the form of an unabridged reprint, copy of an article, or referenced publication. The agency published a nonbinding guidance with fda recommendations for good reprint practices. On friday, february 15, 2008, the fda published its draft guidance on good reprint practices for the. In the form of an unabridged reprint, copy of an article, or referenced publication. Fda is revising its 2009 guidance on good reprint practices to clarify the. 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. This white paper describes the fundamental requirements of good documentation practice gdp routinely used within the pharmaceutical industry as best practice standards or as a direct requirement of the code of good manufacturing practice gmp. Good reprint practices for the distribution of medical.
The draft guidance is intended to replace a nowexpired provision in the fda modernization act that allowed temporary use of journal articles under certain conditions. He thinks the fdas existing january 2009 guidance for industry on good reprint practices weakens the u. This guidance is intended to describe the food and drug administrations fda or agency current thinking regarding good reprint practices. Fda finalizes guidance on distribution of reprints clarifies how manufacturers can hand out journal articles to docs.
Fda finalizes guidance on distribution of reprints. Fda updates reprint guidance, reiterates narrowness of off. Good guidance practices ggps are fda s policies and procedures for developing, issuing, and using guidance documents. From plis online program current issues in fda regulation. Fda started to develop the concepts for good reprint practices in 1997 in response to fdama. The nature of the guidance and limits on its proscriptive. Kate jurcik, director, global regulatory affairs, takeda pharmaceuticals international co. 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. Federal register comprehensive list of guidance documents. According to the fda, offlabel promotion circumvents the charles andres.
The new guidance document, when finalized, will repeal and replace the 2009 reprint guidance. Fda expands and clarifies its good reprint practices guidance. Fda, draft guidance, responding to unsolicited requests for offlabel information about prescription drugs and medical devices dec. From plis online program current issues in fda regulation of. This revises the fdas 2009 draft guidance document on the subject, which was titled. The fda has published a document that provides guidance to the industry concerning good manufacturing practices for cosmetics and is intended to assist in identifying the standards and issues that can affect the quality of products. Guidance for industry1 a food labeling guide this guidance represents the food and drug administrations fdas current thinking on this topic. Jan 27, 2009 the good reprint practices guidance is the first formal pronouncement of the fda s position relating to the dissemination of offlabel information since the sunset on september 30, 2006 of the provisions in the food and drug administration modernization act that govern the dissemination of enduring materials. Good reprint practices guidance fda recently finalized a 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 fda intends the guidance to provide manufacturers. Fda provides the pharmaceutical guidelines for all the stages from raw material to finished pharmaceutical products.
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 february 20, 2008, the u. Fda revisits rules on drug and device communication. Fda issues guidance document regarding good reprint. Implications for drug products timothy candy, principal consultant, regulatory affairs, opus regulatory, inc. On friday, february 15, 2008, the fda published its draft guidance on good reprint practices for the distribution of medical journal articles on unapproved new uses of approved drugs this article summarizes some of issues raised by fdas proposal that pundits and experts are debating on the internet, in the press and in official. The fda recently finalized its 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. Refer to previous guidance regarding unapproved uses of approved products. Requirements for good documentation practice gdp learn all about the good documentation practice including basics, gmp document preparation, issuance and retrieval of records, recording of time, correction of entries, handling of missing entries, blank space and cancellation of gmp records. Importantly, such information must be truthful, nonmisleading, and consistent with the weight of credible evidence on an offlabel use of the product. It does not create or confer any rights for or on any person and does not operate to bind fda or the public. 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. Distributing scientific and medical publications on risk. If your document says what actions took place in the development or manufacturing of product so that anyone, including auditor or inspector has documented evidence that you did exactly what you said. 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.
Proposed guidelines on the appropriate dissemination of. Such offlabel promotion, the fda maintains, misbrands4 the product. The fdas new guidance for offlabel promotion is only a start. 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 drug or medical. Good documentation practice commonly abbreviated gdp, recommended to abbreviate as gdocp to distinguish from good distribution practice also abbreviated gdp is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. Distributing scientific and medical publications on. 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.
The us food and drug administration fda on february 15, 2008, issued draft guidance on good reprint practices for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of fdaapproved drugs and medical devices. Fdas good reprint practices guidance pharma marketing. Fda issues final guidance on good reprint practices. Good documentation practice gdp rightfirsttime approach for the document is gdp to ensure identity, authenticity and accuracy of records. Fda issues new guidelines for distributing reprints on off. Food and drug administration 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.
Apr 01, 2019 good guidance practices ggps are fda s policies and procedures for developing, issuing, and using guidance documents. Advamed guiding principles for product communications. 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. Using offlabel communications to responsibly advance. Apr 21, 2008 food and drug administration 5600 fishers lane, rm. Gdps are enforced by regulatory agencies such as the fda, tga, emea, health canada or who. The guidance is titled good reprint practice for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drug and approved or cleared medical devices the guidance and is available on the fda website. While some guidance was better than no guidance, fda received several comments asking for clarification on how the principles applied to medical textbooks, and also received two citizen. 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. Guidancecomplianceregulatoryinformationguidancesucm070072. Guidance discusses good reprint practices but stops short of labeling these as a safe harbor from prosecution for marketing an unapproved or misbranded product b. One year later, the fda published its most recent final guidance, referred to as good reprint practices which is much more permissive than any of its previous guidance. It was a big day in january 2009 when fda finally issued guidance for manufacturers governing the distribution of medical journal articles and reference publications. Comments of the new york state department of health.
Fdas position on offlabel use and promotion of drugs and. Advamed members support continued dialogue with the fda to establish clear. Responding to unsolicited requests for offlabel information about prescription drugs and medical devices. 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. Fdas good reprint practices guidance pharma marketing network. Jan 01, 2010 while the fda does not regulate a physicians decision to prescribe fda approved drugs for offlabel uses, its recent 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. Fda draft guidance permits use of offlabel information. 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. Proactive communications about medical products between. Good reprint practices, the document lists conditions. While the fda does not regulate a physicians decision to prescribe fdaapproved drugs for offlabel uses, its recent 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.
This note is brought to you for free and open access by the student journals. It is intended to inform the public of the existence and availability of all of our current. What is the role of the fda in offlabel communications. It was a big day in january 2009 when fda finally issued guidance for manufacturers governing the distribution of medical journal articles and. Good reprint practices for the distribution of medical journal articles and medical or scientific reference. Fdas good reprint practices guidance pros and cons of the proposed rules for. Attendance is free and early registration is recommended. Known as good reprint practices, the document lists conditions under. Fda has proposed new rules to guide the pharmaceutical industry in promoting offlabel uses of drugs. Promoting medical products globally baker mckenzie. Cfl guidance if a firm communicates information that is not contained in its products fdarequired labeling but that is determined to be consistent with the fdarequired labeling, fda does not intend to rely on that communication to establish a new intended use. Moderated by heidi gertner, partner, hogan lovells us llp. Guidance for industry1 a food labeling guide this guidance represents the food and drug administrations fda s current thinking on this topic.
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