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  • 1.  Quoting the FDA

    Posted 23-Mar-2018 10:40
    Hello, can anyone shed some light on if there are any rules or guidelines on what you can quote from the FDA and how?  Specifically in regards to their publications, announcements, or website.  


    TIA

    Kat

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    Kathaleen DeBarris, RAC
    RAQA Analyst
    Boulder CO
    United States
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  • 2.  RE: Quoting the FDA

    Posted 23-Mar-2018 19:35
    Hi Kathaleen,

    As far I know, from my experience there is no rule or guidance on how you can quote the FDA guidance and it all depends on how / where you quote. Example, if you are presenting  a topic or doing a training, then a simple references slide or section can be utilized. If you are writing for college papers or any specific seminars you need to follow the citation rules (e.g. APA, Chicago  Style etc.)

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    Loganathan Kumarasamy
    Senior Consultant
    Zifo RnD Solutions
    Waukegan IL
    United States
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    Original Message


  • 3.  RE: Quoting the FDA

    Posted 24-Mar-2018 10:00
    As a former FDA Deputy Associate Commissioner for Public Affairs I can say that FDA statutes, regulations, guidelines, publications and webs postings are public information and fully available to reference and or quote.

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    Christopher Smith, CQE, RAC
    Coastal Pharmaceutical Consultants, Inc.
    7950 Old River Road
    Burgaw, NC 28425, USA
    910.789.1232 (mobile)
    chrissmith@coastalpharmaconsultants.com
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    Original Message


  • 4.  RE: Quoting the FDA

    Posted 04-Apr-2018 12:53

    I would agree with this. There is no copyright given it is government material but citations according to profession are the norm.

    Gina




    Original Message


  • 5.  RE: Quoting the FDA

    Posted 25-Mar-2018 05:01
    As the FDA information on the website is public information, agree with the others that if you are quoting in a public forum or presentation you include the source information/recognition/reference and referencing in a white paper/book/article, then using standard citation rules.  If you are quoting something that an FDA employee said to you or quoting information from not publicly available information, i.e. from a submission or Q-Sub meeting results, then you have to be careful to have disclosure or acceptance of that information being quoted or referenced.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 6.  RE: Quoting the FDA

    Posted 26-Mar-2018 09:06
    Dear Kathaleen,

    Agree with all of the responses.  I would also add that it depends on "who" wants to do the quoting.  For example, if a sponsor of a drug wants to quote an FDA press release regarding their product, there may be statements that the sponsor may not be able to present.  I've run into this a few times where FDA has made statements regarding a drug product the we were not able to restate - FDA can made statements regarding products that a sponsor may not be able to make based on the current rules for advertising and promotion.

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    Tracy Rockney JD
    Co-Founder & Managing Partner
    Libertyville IL
    United States
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    Original Message


  • 7.  RE: Quoting the FDA

    Posted 26-Mar-2018 09:55
    What about when it comes to advertising?  Can we quote an FDA announcement, publication, or website if the intent is for advertising?

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    Kathaleen DeBarris, RAC
    RAQA Analyst
    Boulder CO
    United States
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    Original Message


  • 8.  RE: Quoting the FDA

    Posted 27-Mar-2018 08:22
    My recommendation is to be very careful with this. FDA dislikes being used for promotion. For the longest time they even balked at "FDA approved" for PMA devices, though now that is allowed. They still don't like use of "FDA cleared" for 510(k) devices. While I am not sure they would act against only a reference, they certainly would scrutinize the rest of the document more closely.

    If you avoid saying "FDA" would might be able to reference factual statements in guidance documents etc and be ok. In general though, this falls under "pushing FDA's buttons" and is a good practice to avoid.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 9.  RE: Quoting the FDA

    Posted 27-Mar-2018 09:13
    You need to be very cautious.  Again, FDA can make statements in their press releases regarding new product approvals that a sponsor may not be able to make.  I view it no differently than selecting a quote from a peer reviewed journal article.  The authors can state a lot of things the sponsor cannot.  A simple question - if the company you are working with made the statement, would it be acceptable content from an A&P perspective?

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    Tracy Rockney JD
    Co-Founder & Managing Partner
    Libertyville IL
    United States
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    Original Message


  • 10.  RE: Quoting the FDA

    Posted 06-Apr-2018 16:30
    I'm with Tracy on this one.   

    As a matter of copyright law, the FDA's content can be cited by anyone without restriction, as government works are public domain.   

    However, if you are in the FDA-regulated space, then the advertising and promotional rules restrict what you can say regardless of who owns the content.   

    Many regulatory professionals have encountered this question in the context of off-label materials such as peer-reviewed journals available for free online, where someone says, "It's a document that anyone can get on the Internet- so why can't I cite to it?"   (Answer: because it's off-label)

    The times I've seen FDA cited in a problematic way is when (smaller) firms want to reference their FDA clearance/approval in the context of a safety or effectiveness claim.    For example, you might see a bulleted list that cites "ease of use," "cost-effective" and "safe" with a phrase under each one providing "proof" and, under "safe," the company wants to say "FDA-cleared safe technology."

    That's the type of advertising that the FDA does not want to see, as they never endorse products.   

    Roger

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    Roger Cepeda, JD, MBA, RAC
    MedTech Law LLC
    roger@medtech.law
    Mobile: 847-421-8361
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    Original Message


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