Out-Law Analysis | 13 Aug 2015 | 5:08 pm | 2 min. read
The US Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) recently took issue with pharmaceutical company Duchesnay over the promotion of its Diclegis product by Kardashian via her social media accounts.
Diclegis is a drug that can be prescribed to women who experience morning sickness during pregnancy and Duchesnay has reportedly confirmed that it "compensated" Kardashian for "sharing her experience" in using Dicelgis with her followers on social media.
However, in a warning letter (5-page / 141KB PDF) to the company, the OPDP said that whilst Kardashian's posting had presented claims about Diclegis' efficacy, it had failed to include "risk information" associated with its use. This omission meant Kardashian's promotion constituted a "misbrand" of Diclegis under US laws, it said. The OPDP said this was "concerning from a public health perspective because [the postings] suggest that Diclegis is safer than has been demonstrated".
Duchesnay faces potential enforcement action from the OPDP if it promotes its product in this way again.
However, despite the OPDP's position in this case, direct marketing of prescription medicines to the public is generally permitted in the US, subject to particular safety and use requirement disclosures being made.
This contrasts with the much more restrictive regime that applies in the UK.
The Human Medicines Regulations generally prohibits direct marketing of prescription medicines to the public in the UK. This is different to the way marketing of over the counter medicines such as painkillers, cough medicines or indigestion remedies is regulated.
The general provisions on the promotion of medicines are set out in the 'Blue Guide' produced by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). Some of those provisions would be particularly relevant to the Kardashian case.
For example, the Blue Guide specifically warns against celebrity endorsements and prohibits recommendations by people who, because of their celebrity status, could encourage consumption of products. As it appears in this case that Duchesnay paid Kardashian to promote their drug, this would fall pretty squarely into this category.
Kardashian endorsed Diclegis via postings on Twitter, Facebook and Instagram. However, both the Blue Guide and Human Medicines Regulations apply across all platforms. Social media postings of this nature will be caught by these UK rules and would not in any way be exempt from the usual additional compliance rules which apply to print or broadcast advertising.
Furthermore, there is particular sensitivity around the use of medicines by pregnant women and this is reflected by the fact the MHRA has developed guidelines on the advertising of medicines for use during pregnancy.
The guidelines, which were developed in consultation with industry representatives and advertising regulatory bodies, require promotions for medicines to be used by pregnant women to make the following disclosure: 'Medicines can affect the unborn baby. Always talk to your doctor or pharmacist before taking any medicine in pregnancy'.
Kardashian's promotion recommended that women consult with their doctors about Diclegis, but did not contain this specific statement.
Louise Fullwood is an expert in life sciences at Pinsent Masons, the law firm behind Out-Law.com