Key Topic 2: Substantiation

All promotional claims must be supportable by some kind of evidence. You will need to consider the quality of evidence that is supporting a claim. In addition be careful about using exploratory end-points as these will usually be insufficient to support a claim.

Materials based upon ‘real world’ evidence should include a statement making it clear that the information is based on real world evidence and is therefore subject to potential bias. For real world studies the term ‘associated with’ should be used to describe findings as opposed to saying a study ‘showed’ a particular effect e.g. In a real world study, using observational data obtained from patients electronic health records, Product X was associated with a reduced annual rate of exacerbations of COPD compared to Product Y

When claims refer to published studies clear references should be given in the material. If using unpublished data to support a claim you should be provided with ‘data on file’ so that you can verify the substantiation of the claim. Refer to the ‘Guidance for Creation of Global Data on File Packets (DoFP))’ for details of how data on file packets are produced and approved, as well as the acceptable format.

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Consider these examples

Superiority claims

In the US Cipher Pharmaceuticals sent a promotional email about their product LIPOFEN (fenofibrate). The contents of the email were as follows:

E-pharm alert: All fenofibrates are not created equal

When a patient is prescribed LIPOFEN (fenofibrate capsules USP) a generic fibrate may not be the best option. Only LIPOFEN offers Lidose technology which:

  • Uses a unique lipid melt matrix system not available with any other generic or brand name fibrate
  • Delivers reliable, consistent and uniform delivery
  • Avoids dependence on particle formulation
  • May improve the safety and efficacy of the active ingredient in LIPOFEN by offering more consistent plasma profiles
 

LIPOFEN Takes Particle Size Out of the Equation”

  • Other fenofibrates are formulated with small particles, which may affect absorption
  • With LIPOFEN, particle size is not an issue
  • Fenofibrate is in an already-dissolved state, making it readily available for absorption
  • LIPOFEN with Lidose technology offers a very homogeneous distribution of fenofibrate in the mass of excipients
  • No crystals of fenofibrate are observed
 

Assuming that the facts about the formulation of LIPOFEN are true, and that appropriate obligatory information was included, which of the following do you agree with?

  • If factually accurate this email is approvable
  • This email makes superiority claims versus all other fibrates
  • To substantiate these claims I would need to see results of head to head studies against other fibrates
  • If there were no head to head data against other fibrates this email would be misleading
Check answer Ruling
×

Ruling

This email was the subject of an FDA warning letter. The FDA stated:

‘In general, claims of superiority must be supported by adequate and well-controlled head-to-head clinical trials comparing appropriate doses and dose regimens of your drug and the comparator drugs. Although we acknowledge that some of the above claims may be true; the totality of the claims and presentations misleadingly implies that Lipofen offers a clinical advantage over other fenofibrate products.’

(There were no head to head comparative data to support the implication of superiority)

 
 

Product adherence claims

DaraBiosciences Inc made the following claims with respect to their oral formulation of tamoxifen (Soltomox) in the US:

Challenge

Compliance and adherence to prescribed tamoxifen therapy is a critical issue in patient care and may affect treatment outcomes.

Difficulty swallowing pills may affect both compliance and adherence to prescribed courses of oral solid medications.

Solution

Liquid medication may be preferred vs. pills by many patients

  • Many adults in the USA were reported to have experienced difficulties with swallowing tablets or capsules at some point, even though most had no problems swallowing food or liquid
  • Research shows that women experience more discomfort with pill swallowing compared to men
  • Many adults who have trouble ingesting their medication have not discussed the situation with a health professional

Soltomox, the only tamoxifen citrate oral solution that may support long-term adherence

 
 

Assuming the bullet points are true and can be substantiated, which of the following statements do you agree with?

  • The final claim is supportable because they say it ‘may’ support long term compliance
  • The final claim needs to be supported by some clinical data
  • Without supporting clinical evidence for the final claim it cannot be approved
  • The evidence on compliance issues with tamoxifen tablets would be suitable to support the final claim
Check answer Ruling
×

Ruling

These claims were the subject of an FDA warning letter. The FDA stated “Promotional materials are false or misleading if they represent or suggest that a drug is safer or more effective than another drug, when such has not been demonstrated by substantial evidence or substantial clinical experience.

It was considered that the claims suggested that, as a result of its liquid dosage form, Soltamox offers a therapeutic advantage over other available formulations of tamoxifen. There were no studies that specifically evaluated the liquid formulation of tamoxifen with respect to compliance. Therefore the claims could not be substantiated.

 
 

Sanctura advert

Take a look at this advertisement. It was the subject of an FDA warning letter for several reasons. See if you can spot the ‘violations’ and then look at the FDA letter to see if you missed anything.