Glaxo will also take out advertisements in medical journals in order to placate the FDA, a powerful regulator that has the power to approve and ban sales of drugs in the US, the world's biggest market for pharmaceuticals.
The embarrassing admission that Glaxo had misled doctors follows a letter from the FDA in January, which suggested that the company's promotional materials 'frequently suggest unapproved uses for Zantac and consistently make comparative efficacy and safety claims that are not supported by adequate data.'
The letter said Glaxo's claim that Zantac was equally effective in smokers and non-smokers was made on the basis of inadequate studies. It said Glaxo should make explicit the approved indications for the drug and criticised Glaxo's suggestions that Zantac is safer than rival treatments such as SmithKline Beecham's Tagamet.
The company tried to play down the significance of the climb-down but Glaxo's shares are likely to come under renewed pressure today. Sales of Zantac represent nearly half of Glaxo's turnover, making it the world's best-selling drug. In the year to June 1992 profits from Zantac exceeded pounds 1bn for the first time.
Worries about the threat from cheaper generic rivals have already contributed to a 25 per cent fall in Glaxo's share price this year from 793p to 597p. The resignation of the chief executive, Ernest Mario, earlier this month further unsettled the company. Glaxo said yesterday that Dr Mario's departure was unrelated to the disagreement with the FDA.Reuse content