Ten years and $1 billion later, close your eyes and imagine; your product has been approved in the US by the Food and Drug Administration (FDA). Your team is overjoyed. Sales teams are trained and ready to go. Launch date nears. Suddenly, you discover that an off-label use of the medication appears in the sales promotion material. Your sales material is non-compliant, but luckily it was caught before going to market. But what about the other promotional material? It will have to be reviewed again, delaying the launch.
If only you had known that the risk of costly surprises like this can be minimized with content comparison software to verify drug promotional material.
How does the FDA define advertising and promotional material in pharmaceuticals?
The FDA does not specifically define advertising and promotional material. However, examples can be found in its non-binding draft guidance [3, 4] on FDA-regulated promotional labeling and advertisements, and elsewhere. These include:
- Advertisements in published journals, magazines, periodicals and newspapers
- Advertisements broadcast through media such as radio, television, online and telephone communication systems
- Oral statements (e.g. to physicians, at trade fairs and other events)
- Presentations and speeches at drug-company sponsored events
The list is not exhaustive, as the FDA views promotional labeling and advertising as “generally any labeling other than FDA-required labeling that is devised for promotion of the product. It is important to comply with FDA distinctions between “disseminating information” and “promotion.” Medical devices are also subject to regulation to prevent misbranding and false claims. [5]
What is content comparison software?
Content comparison software compares any two documents for deviations, such as advertising and promotion material approved by medical, legal and regulatory (MLR) representatives, with your downstream digital or online advertising and promotional content. Comparison software will immediately highlight differences between the approved document and the copy, regardless of layout, format (ex: Word to PDF or Excel to PDF) and language. It can verify graphic artwork, such as artwork in final printer proofs, check industry- and corporate-specific spelling and detect, decode and grade barcodes.
With TVT, you can also compare digital files (e.g. PDF artwork file) with online promotional material by simply inserting the URL. Furthermore, TVT can be integrated with any information management system and at any step in your workflow.
Why is content comparison software important?
Without a content comparison software, manual proofreading is typically how advertising and promotional material is being reviewed before hitting the market. Manual proofreading is time consuming and comes with the risk of human error. Content comparison software minimizes this risk, making it an indispensable tool to help ensure that advertising and other promotional materials are compliant with standards set by regulatory authorities. Two of the most serious – and all-too-frequent – drug marketing mistakes are making false claims and including off-label uses of a prescription medicine in advertising and promotional materials.
The cost of non-compliance
Non-compliance is costly. All signs in 2023 have pointed to the FDA stepping up its pursuit of violations.[1] If communications are not consistent with approved labeling (CFL), the FDA’s Office of Prescription Drug Promotion (OPDP) may issue a warning letter.
Furthermore, so-called qui tam lawsuits (where a whistleblower may receive a portion of recovered funds) involving off-label advertising and promotion have resulted in settlements as high as $3 billion. According to one estimate, violations of the False Claims Act and off-label promotion by life science companies in the US resulted in settlements of over $9 billion in 2022 alone.[2]
Other consequences of non-compliant promotional and advertising include:
- Financial cost of cancelling, rescheduling, re-working promotional material and re-launching campaigns
- Time lost on product promotion and through the need for remedial action
- Damage to reputation through warning letters, issuing correction statements or apologies, and recalled marketing materials
Organisational approaches to ensuring compliance
In smaller companies, responsibilities are more likely to be bundled in marketing or regulatory affairs departments. In some cases, responsibilities are outsourced with the advertising and promotional material, along with labeling and packaging. In larger companies, an internal review board (IRB) or a promotional review committee (PRC) often has oversight. In any case, regardless of how you conduct oversight, it should always involve medical, legal and regulatory representatives (MLR), in addition to marketing.[6]
How TVT helps ensure compliant advertising and promotional material
TVT is a content comparison software built for the life science industry to meet strict regulations and ensure patient-safety through correct and compliant content. Here is a practical example of how TVT content comparison software can help you:
You wish to create a micro-website to promote a prescription drug. Your content has been drafted and approved by MLR. Downstream, a designer helping the content manager builds the website.
But you need to verify that it is the same content. Has non-compliant text from a document that included off-label statements been accidentally built into the micro-website? Has one of the contraindications not been added to the website? Or perhaps a few lines of placeholder text have not been deleted.
A quick comparison of website content with TVT against the approved document will verify the content, highlighting any deviations. You can then annotate the content for any changes and create a report documenting all actions.
Similarly, if printers make small but unapproved changes to artwork documents, TVT comparison software will find this detail in the printer’s proof.
“’The devil is in the detail’”, says one of our customers. “We have one hard and fast rule: no change should be made without our approval. We can see any changes at a very fine level now – ones that might have gone unnoticed before.” Read the full case study.
TVT will help you:
- Achieve consistency and compliance across all advertising and promotional materials
- Avoid damages and FDA enforcement action resulting from off-label claims
- Save time by reducing revision cycles and project delays, and identifying deviations earlier in review cycles
- Achieve transparency among reviewers by documenting all actions
- Have better version management
- Reduce human error
- Increase review quality
- Develop a better review culture
- Save money
- Protect your reputation
For over 20 years, TVT has been trusted by the global leaders in life sciences. If you would like to see how TVT can help your advertising and promotional material, contact us to take a look at what you need.
- See www.phillipsandcohen.com/whistleblowers-played-major-role-in-glaxo-case-leading-to-glaxo-s-record-settlement/, www.phillipsandcohen.com/off-label-marketing/, and www.sidley.com/en/insights/newsupdates/2023/08/new-warning-letter-reflects-recent-shifts-in-fda-enforcement-of-drug-promotion
- https://www.veeva.com/blog/making-mlr-review-and-approval-more-efficient-and-effective/
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products. Questions and Answers. Guidance for Industry. See: https://www.fda.gov/media/134862/download
- See line 189 of the non-binding guidance. Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs. www.fda.gov/media/128163/download.
- For more on medical devices, see www.compliancequest.com/blog/fda-regulation-medical-device.
- For more, see the excellent article at globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/
