June 01, 2018
AstraZeneca reprimanded by UK drug regulator for 'misleading' press release
The Prescription Medicines Code Of Practice Authority (PMCPA) received a complaint in January from GlaxoSmithKline about an AstraZeneca release from November 2017.
The release referred to a European Medicines Agency recommendation of the marketing authorisation for asthma drug benralizumab (marketed as Fasenra) for use by adults with a severe form of asthma. GSK said that some of the data on clinical endpoints was "unbalanced and misleading due to the omission of the full available evidence".
The PMCPA, which enforces the Association of the British Pharmaceutical Industry (ABPI) code, considered a total of 12 potential breaches of the code, including Clause 2 of bringing discredit upon the industry.
In a ruling published yesterday, AstraZeneca was found to be in breach of four parts of Clause 7 around information, claims and comparison, and two parts of Clause 26 on relations with the public and the media.
However, while noting that it was "extremely important that press releases were accurate, balanced and not misleading" the PMCPA did not rule a Clause 2 breach.
The panel also dismissed GSK's suggestion that a claim in the press release constituted an advertisment to the public for a prescription-only medicine. In addition, it said GSK's claim that AstraZeneca had failed to provide it with further information about the release during inter-company dialogue prior to it lodging a complaint.
GSK declined to comment when approached by PRWeek. AstraZeneca has not responded.
Earlier this week, AstraZeneca reported that Fasenra had not been successful in a trial for its application in another therapy area. Industry news site FiercePharma wrote of the news: "Now, Glaxo is waiting for a decision from the FDA [on separate drug Nucala] - and if it gets a green light, it'll give the company a major edge over AstraZeneca."
This story first appeared on prweek.com.