GSK Breaches ABPI Code of Conduct

August 26, 2010
Stephanie Sutton
ePT--the Electronic Newsletter of Pharmaceutical Technology

GlaxoSmithKline Consumer Healthcare, Cephalon UK Ltd, and ProStraken Group plc have been accused of breaching the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice.

GlaxoSmithKline Consumer Healthcare, Cephalon UK, and ProStraken Group have been accused of breaching the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry. The code covers the promotion of medicines, including journal and direct-mail advertisements, and the provision of information to patients and the public.

The companies have breached the code in different ways; however, all three stand in violation of Clause 2 of the code: "bringing discredit upon and reducing confidence in the pharmaceutical industry," according to a statement released by the Prescription Medicines Code of Practice Authority (PMCPA), which administers the ABPI Code of Practice.

GlaxoSmithKline Consumer Healthcare
The case against the pharmaceutical giant stems from the company making misleading claims about its smoking cessation aid NiQuitin. The complaint was made by Johnson & Johnson after the company received a mailing promoting the product. The mailing contained the claim, “From day one NiQuitin 25mg Clear Patch delivers more nicotine than any other therapeutic nicotine patch,” which was alleged by Johnson & Johnson to be “ambiguous and misleading,” primarily because of a lack of clarity relating to the measures of speed and the extent of nicotine delivery upon which the claim was based.

In response, the PMCPA ruled that the company was in breach of Clause 2, as well as other clauses relating to:
• making misleading claims and comparisons
• using misleading comparisons
• failing to maintain high standards
• failing to comply with an undertaking.

Cephalon
Cephalon breached the code by providing free stock of its breakthrough pain treatment, Effentora (a Schedule 2 controlled drug that is subject to ordering/storage and prescribing restrictions) without “sufficient controls.” According to the code, no more than 10 free samples should be provided but in this instance the company supplied 30. The complaint also attached emails that stated Effentora was supplied as an inducement to prescribe and “assist [Cephalon] with moving forward with a formulary application.”

Despite an appeal, Cephalon was ruled as breaching Clause 2, as well as further clauses relating to failing to maintain high standards.

ProStrakan
ProStrakan’s breach of the code stemmed from the company making claims about its drug Abstral that were misleading and did not comply with a previous undertaking. In a previous case (case number: AUTH/2207/2/09), the PMCPA had ruled that a “10-minute pain relief claim” of Abstral was in breach of the code as the product only provided pain relief from 15 minutes after administration onward. The most recent case draws from a complaint made by Cephalon. According to the company, a revised promotional campaign for Abstral inferred that the product was actually even faster in onset than 10 minutes by using the advertisement heading "To hell and back in minutes."

The ABPI’s Prescription Medicines Code of Practice Authority (PMCPA) has advertised brief details of all cases in the BMJ and The Pharmaceutical Journal on Aug. 21, 2010, and in The Nursing Standard on Aug. 25, 2010. The full case reports have been published in the PMCPA’s August Code of Practice Review.