FDAnews Drug Daily Bulletin


Nov. 18, 2005

The UK's health watchdog is ratcheting up enforcement of misleading drug promotions, announcing that it intends to review all promotional materials for newly licensed medicines before they are disseminated.

Previously, the Medicines and Healthcare products Regulatory Agency (MHRA) only vetted advertisements for some new drugs based on a risk assessment. The new agency policy was unveiled at a recent MHRA meeting in London.

"By vetting advertising material on all new medicines, we will provide an additional safeguard to ensure that healthcare professionals and the public are not misled," MHRA Policy Group Manager Jeremy Mean said. "It is essential that clear information is given at the beginning of the advertising process for a new medicine and the messages are not misconstrued. When it comes to safety issues, we will not allow advertising that undermines public health."

The MHRA said the vetting period for drug promotions would likely last three to six months, but "could take longer should any problems be identified."

The agency's actions come on the heels of an increasing number of complaints regarding misleading or inappropriate advertising by drug firms. One such complaint, the MHRA said, involved a promotional trailer for Proctor & Gamble's (P&G) osteoporosis treatment Actonel (risedronate sodium). Two healthcare professionals expressed concern to the MHRA that the mailer's presentation suggested the information was provided by the National Institute for Health and Clinical Excellence, rather than by P&G. The company later agreed to amend the contents of the mailer.

To inform manufacturers about its updated promotional policies, the MHRA has released a revised version of its "Advertising and Promotion of Medicines in the UK" blue guide.

To view the updated blue guide, go to http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2022533&ssTargetNodeId=387 (http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2022533&ssTargetNodeId=387).