WASHINGTON DC: US pharma giants, already under pressure from lawmakers to curb their enthusiasm for direct-to-consumer drug advertising, are putting their case to regulators for easier off-label promotion of their products.
A coalition of ten major names, including Pfizer, Bayer, AstraZeneca and Johnson & Johnson, have employed the services of former Food and Drug Administration chief counsel Daniel Troy to lobby his ex-employer.
The companies, together with a small number of patient groups, hope to relax rules governing the dissemination of medical journal articles to doctors and hospitals which inform of new conditions for which current drugs could be used but which the FDA has not formally approved.
The regulator says it is not about to loosen the rules now in place, but seeks to clarify them.
There are currently three congressional inquiries, either in progress or in the pipeline, into the drug industry's $5.4 billion (€3.39bn; £2.7bn) annual spend on DTC television ads.
Despite the industry's best efforts to promote the value and integrity of self-regulation, commentators believe lawmakers could impose further limits, more emphatically so if a Democrat wins the top job at the White House later this year.
The chairman of the House Committee on Energy and Commerce, Democrat John Dingell warns: "Drug companies should know that they will be held accountable for inappropriate behavior and inaccurate representations made in their ads."
Data sourced from Wall Street Journal Online; additional content by WARC staff