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New advertising checks could delay UK launches

Published on 10/11/05 at 09:22am

The MHRA has conceded that checks on advertising and promotional materials for new prescription medicines could delay their UK launch - but says the system will help restore confidence in the industry.

The new measures are to be introduced in response to the Commons' Health Select Committee report into the influence of the pharmaceutical industry, which was highly critical of the MHRA and the industry.

The committee of MPs said existing measures were not preventing companies from making inflated or misleading claims for their products to healthcare professionals.

The new measures will see all new products undergoing pre-launch vetting by MHRA staff, a process which the government agency says will normally take three to six months, but could take longer should any problems be identified.

To help reduce any delays to a minimum, the pre-vetting process will be conducted in parallel with the licensing procedures.

But MHRA executives concede the new checks could mean at least two extra weeks delay to a launch - and industry executives say they are concerned the wait could be longer.

MHRA policy group manager Jeremy Mean told industry delegates at a special MHRA conference this week that the pre-vetting of advertising was necessary to help restore confidence in the industry and the regulator.

He said the media had been full of stories in recent years about controversy and distrust of the pharma industry and medicines regulators, and signalled that both needed to show a positive response.

"There's nothing better than a story about sleaze or misleading-ness or the evil pharmaceutical industry," he said.

"That's why it's the responsibility of all of us to stand up to scrutiny. And that's why we have to get it right the first time  and if we don't get it right that we say so."

A number of industry representatives present at the meeting voiced their concerns about how the checks could hold up the launch of new products, with one saying it was 'inevitable' that delays would occur.

The MHRA is nevertheless determined to adopt a new harder line on advertising misdemeanours, and is now publishing details of all its judgements on its website.

One recent investigation was sparked when two healthcare professionals complained about a promotional trailer from Procter & Gamble for its osteoporosis drug Actonel sent out in May 2005.

The complainants said the mailer appeared to be presenting information from NICE when in fact it was from the company, and said they were also concerned the information did not accurately reflect NICE guidance on the use of bisphosphonates in postmenopausal women.

Procter & Gamble agreed to amend the mailer and its contents.

The new rules coincide with the publication of the MHRA's Blue Guide Advertising and Promotion of Medicines in the UK that includes a number of minor amendments due to changes in EU law.

External links:

Medicines and Healthcare products Regulatory Agency  

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