UK regulator is to take lighter approach to drug advertisements

The UK regulator of medicines is going to take a “light touch” approach to the pre-publication vetting of material that advertises new drugs if drug companies have a good track record in complying with the law.

The Medicines and Healthcare Products Regulatory Agency (MHRA) started to check that advertising material for all new drugs complied with the law before the advertising was launched—known as pre-vetting—after a recommendation by the House of Commons Select Committee in its landmark 2005 report on the influence of the industry.1

At the time the committee said that intensive marketing that encouraged inappropriate prescribing of drugs “must be curbed” and noted that 80% of drug advertising was aimed at doctors, with an increasing amount targeting nurses with new prescribing powers.

June Raine, the MHRA’s director of vigilance and risk management of medicines, said that the regulator had given a commitment to continue to pre-vet advertising materials for all new drugs but that there was now some flexibility.

“The room for manoeuvre is to make [assessment times] shorter and more proportionate to risk if the company has an excellent compliance record,” she said. Instead of assessing many advertising pieces for these companies, the regulator would be looking at “perhaps a small number of key pieces, and that would be done in a very light touch way,” she told the BMJ at an MHRA meeting on advertising for pharmaceutical executives in London on Monday 25 February.

The MHRA’s advertising standards unit is made up of a very small team of two advertising assessors. Beryl Keeley, who manages the unit, added, “Already we will take a lighter touch if initial materials are good—we will vet less materials. If initial materials are bad, we will tend to look at a much larger number than we would otherwise.”

She added, “We aren’t ready to relinquish our commitment to pre-vet all new active substances as yet. It is a potential next step. We might think about it, depending on the evidence we get running forward.”

Pre-vetting has helped to improve standards across the industry, as most big companies have been through vetting at least once, she added, and it has resulted in “far fewer complaints” about advertisements for new drugs.

The MHRA aims to pre-vet an individual advertising item, such as an advertisement in a medical journal, within five days, with the overall vetting period lasting about two months for all a product’s promotional items. However, the process could take longer if initial materials were not satisfactory and if there were concerns about the quality of the submissions or if key pieces of advertising were still being developed.

Last year the MHRA vetted the advertising of 40 products (including 27 new drugs and 12 products affected by safety concerns or major new indications), down by 20% on the previous year, according to the MHRA’s seventh annual report on advertising, which was published on Monday.

On average, the MHRA pre-vets about 12 advertising items for each product, but this fell to eight last year. The report said this was “probably due to a combination of a change in the mix of products vetted and a shorter vetting period because initial materials were of a high standard.”

The regulator’s pre-vetting does not, however, protect companies against subsequent complaints. Last year two complaints were upheld against pre-vetted advertising.

In the first case the industry’s self regulatory body, the Prescription Medicines Code of Practice Authority, which considers most complaints about the promotion of prescription only drugs, ruled that a press release for the antidiabetes drug linagliptin (marketed as Trajenta), was misleading and exaggerated its properties. The second case involved an investigation by the Advertising Standards Authority into advertising for a combination analgesic product, Nuromol (paracetamol plus ibuprofen).

Although the MHRA reviews such cases closely for learning points, it noted that these represented a “small proportion” of vetted products and that this suggested that the procedure was “successful” in improving advertising standards.

Jeremy Mean, the MHRA’s manager for access and information for its medicines and standards group, said that it took a “big agency to be able to say we probably got it wrong.”

The regulator would not use the same assessors that vetted the ad to look into any subsequent complaint it received about the advertisement. Mean said, “We would want a broader range of people, possibly a panel of assessors, to ensure we looked at the right things in the first place . . . Is there an angle that we did not look at?”

Keeley noted, “It’s a five day process [vetting], and we don’t claim it has the same rigour as a complaint investigation.”

Heather Simmonds, director of the Prescription Medicines Code of Practice Authority, which acts to ensure that companies follow the code of practice on the promotion of drugs published by the Association of the British Pharmaceutical Industry (ABPI), had some sympathy for the MHRA. She said, “Everyone has to remember that when you are pre-vetting, you have five days. When you are complaining, you’ve got months to formulate a complaint.”

However, she emphasised that the authority did not let “a little thing like” pre-vetting to influence its investigation into complaints, in the same way that the MHRA would not let pre-vetting influence any such investigation.

A spokesperson for the ABPI told the BMJ: “The MHRA vetting of adverts is based on law, whilst the ABPI code of practice goes further than the law. Therefore once [an item of advertising] has been vetted that does not exclude the possibility that it will undergo further scrutiny by the PMCPA [Prescription Medicines Code of Practice Authority]. Also, the MHRA does not make guarantees that the adverts will not be vetted further. We are not advocating any changes to the current arrangements.”

Keeley, Raine, and Simmonds all said that the industry’s self regulation of drug promotion was working.