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May 17, 2024

The Schlafender Hase Team

Off Label Marketing: How to Avoid False Claims in Pharma

The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case. [1] Flip the coin and you also find a strong financial incentive for whistleblowers to report non-compliance. This is because, according to US law, a whistleblower may receive a portion of funds recovered in a so-called qui tam lawsuit.

What is an off-label claim?

Off-label use of a medication is when a treatment is used for symptoms or conditions that are unapproved by the US Food and Drug Administration (FDA), in dosages that have not been approved, or in unapproved patient groups. [2] Prescribing a drug for off-label use is legal and beneficial to some patients when there is no approved treatment for the patient’s condition and circumstances, or all of the approved treatments have been tried and none has helped. [3] However, advertising off-label use of treatments not medically accepted and may lead to those responsible being liable for false claims. This amounts to fraud and can be punishable under the False Claims Act (FCA) in the US, as it results in incorrect claims by pharmacies under Medicaid.

One term you are likely to come across is “promotional materials,” which the FDA uses as a collective term to describe promotional labeling and advertising materials. Examples “include, but are not limited to, television advertisements (ads), brochures, booklets, detailing pieces, internet websites, print ads, exhibits, sound recordings, and radio ads.” [4] Off-label advertising promotes a medicine for an unapproved use in media such as those examples just given. “Off-label promotion,” however, is generally used in a broader sense. It goes beyond advertising to include unlawful practices such as paying incentives to sales reps to promote off-label uses, physician kick-backs for off-label use, travel perks for events promoting off-label use, and so on.

FDA guidelines for advertising prescription drugs

While an off-label claim in advertising for a prescription drug is illegal and exposes the company to prosecution under the False Claims Act, advertising per se is allowed in the US and closely regulated by the FDA. The key distinction here is between the need to provide information on the prescription drug – disseminating information – and promotion. Regulations on prescription drug advertising are outlined in 21CFR202.1 [5]. It provides detailed guidance on what must be included in your advertisements and how it should be presented. That means, for example, listing ingredients in the right order, using names correctly and not using fanciful proprietary names or making statements implying the product is a “super-drug”, or exaggerating the role of an ingredient that is quite common.

How to avoid an off-label claim

Consistency with your FDA-approved labeling – the primary information source – is the key factor in compliant advertising. Any off-label claims – whether it be a claim or error about dosage, or even intentionally or unintentionally listing an inactive or inert ingredient in such a way that its importance is overstated, will be misleading. This may result in a warning letter from the FDA’s Office of Prescription Drug Promotion (OPDP), endanger the health of patients and lead to costly litigation. But how does the FDA decide whether the product communication is consistent with the approved labeling?

For this, the FDA uses three-factor criteria. [6]

  • Factor 1
    • Indication
    • Patient population
    • Limitations and directions for handling/use
    • Dosing or use regimen/administration

There should be no inconsistencies or conflicts in any of these in regard to approved labeling.

  • Factor 2

“Whether the representations/suggestions about use of the product in the product communication increase the potential for harm to health relative to the information reflected in the FDA-required labeling.”

  • Factor 3

“Whether the directions for use in the FDA-required labeling enable the product to be safely and effectively used under the conditions represented/suggested in the product communication.” (see Page 7 of the non-binding guidance for examples illustrating this “interaction” between advertising and labeling.)

The difference between Factor 2 and Factor 3 is that the one refers to how communications shape up when also understood in the context of labeling, and Factor 3 is the reverse: How labeling shapes up when understood in the context also of the communication.

Against this background, compliance is best achieved by:

  • Maintaining an up-to-date document centre for your approved documents, reusing these documents (such as your approved labeling), correctly tagging and filing current and outdated versions
  • Streamlining your workflows (especially when verifying your versions)
  • Implementing tools that allow you to manage documents across different media formats

How TVT helps avoid off label claims

Your overarching aim is to achieve consistency. Some of your material for comparison will be word-for-word, graphic-for-graphic identical content. In other cases, the promotional material might vary insignificantly and still be compliant. Some promotional material may also have been submitted for review along with an earlier regulatory submission.

TVT document comparison and proofreading software will verify whether promotional material deviates from the approved labeling or other FDA-approved documents. It will highlight any deviations immediately for further review. You can annotate deviations for correction, or for further action such as clarifying your promotional material with your responsible body that has legal, medical and regulatory (MLR) competencies. The core module TVT Text Verification Tool® has add-on modules TVT Artwork® for verifying graphical content, and TVT Barcode® to grade the readability of 1D or 2D barcodes (scan codes). TVT Spelling® includes functions to check  industry-specific dictionaries for spelling, and to spell-check proprietary names.

As borne out by the examples of advertising provided by the FDA, online formats must also be verified against approved documents. This can be easily done with TVT by inserting the URL of, say, electronic labeling (e-labeling). The online content is loaded and ready for comparison against identical digital copies in PDF format (or any other format). Because labeling and promotional materials must be constantly updated to reflect changing regulatory requirements or any new information about the approved product, TVT is an invaluable tool for ongoing quality assurance and compliance (and preventative action). It is collaborative and can be integrated into workflows in any information management system.

For more on how TVT helps assure the quality and compliance of promotional materials, read our blog here

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

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