Statements must be accurate, fair and balanced
- FAIR
Generally speaking the requirement for being ‘fair’ refers to statements that make comparisons.
Only products or services intended for the same purpose should be compared.
For example it could be considered unfair to directly compare the analgesic efficacy of a strong opioid with paracetamol as the two medicines are in different classes and are generally used for different pain severities. - BALANCE
This generally refers to a balance of positive and negative facts (for example mentioning important safety warnings as well as efficacy).
Picking certain facts out which do not necessarily reflect the balance of all of the evidence available is sometimes called ‘cherry picking’ and is not acceptable.
Consider this example relating to balance
The following tweet (written by a celebrity) was posted on Twitter by American company Duchesnay Inc. They market the product DICLEGIS (doxylamine succinate and pyridoxine hydrochloride)
OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.
The US PI for DICLEGIS contains the following important information:
“DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use :DICLEGIS has not been studied in women with hyperemesis gravidarum.”
It also includes Warnings and Precautions regarding activities requiring mental alertness and concomitant medical conditions. In addition, the most common adverse reaction reported with DICLEGIS was somnolence.
Which of the following do you agree/disagree with?
- This is acceptable as they have included a link to the important safety information
- This tweet is not balanced as it omits important safety information
- Omitting safety information in a tweet is acceptable due to the word limit on tweets
- This tweet misleads the reader into thinking that DICLEGIS is safer than has been demonstrated
- This tweet is acceptable as promotion to the public is allowed in the US
Ruling
This tweet was the subject of an FDA warning letter because of the lack of balanced information that made it misleading. FDA said it was misleading as it left out all safety information about the product as well as the material fact that the product had not been studied in women with hyperemesis gravidarum. The link to the safety information did not mitigate the misleading omission of risk information. A number of sanctions were imposed including issuing corrective tweets.
