All new product marketing to be pre-vetted in UK
pharmafile | September 2, 2005 | News story | Medical Communications, Sales and Marketing |Â Â Â
Advertising and marketing materials for all new products are to be vetted by the UK regulator for the accuracy of claims.
The government has revealed that the MHRA is to re-organise its activities to ensure promotional material for any new product meets regulations before it is launched.
The announcement is part of the government's response to the Health Select Committee inquiry into the influence of the pharmaceutical industry, which recommended a number of major changes.
The government has rejected many of the proposals, while it said many more were already being addressed through existing initiatives.
But the government agreed with the committee on a handful of key areas. It confirmed action will be taken on the following:
- MHRA pre-vetting of promotional material for all new products
- Ministerial Industry Strategy Group to begin 'blue skies' thinking on how to increase safety measures for newly-launched drugs
- Investigate penalising companies through the PPRS if they are found in breach of advertising rules
- Consider review of 'evergreening' and other alleged practices that impede generic drugs
- Proposal for independent review of MHRA every four years
- Inform public about commercial element of pharma's disease awareness campaigns (without introducing promotional element)
In addition to these new proposals, the government response underlined how new EU legislation would also tighten controls on medicines. Most significantly, this includes provision to re-evaluate medicines according to their risk/benefit profile throughout their lifecycle.
It says this measure, in tandem with more frequent Periodic Safety Update Reports, would strengthen the current review process.
The ABPI has welcomed the government's conclusions, in particular the emphasis on drug safety and recognition of the industry contribution to the health and economy of the UK.
But the ABPI is less enthusiastic about plans to introduce pre-vetting for all new product promotional materials.
It warned: "It is important that this action does not further delay innovative, new medicines from reaching patients. The government must ensure that the MHRA has the appropriate staff with the right levels of expertise to carry out such pre-vetting without delaying the medicine's availability."
The MHRA already pre-vets promotional materials, but these are not necessarily for new products. The government says the regulator pre-vetted 30 products last year, a figure that will it drop to around 20 for new products. The government says the process can be planned into the licensing timetable for new products, and need not delay launch dates.
The ABPI also indicated its opposition to using the PPRS to punish companies found in breach of advertising regulations, stressing that it was "designed as a mechanism for regulating company profitability, not for controlling marketing standards".
The industry organisation welcomed the government response on a number of other areas, including publishing clinical trial data and relationships with patient groups, but said the lack of UK-based scientists had been underestimated. "Further action in this area would be welcomed," it concluded.
