There has been a flurry of recent reports on alleged non-compliance with medicines advertising regulations. Both the UK drugs watchdog, the Medicines and Healthcare Products Regulatory Agency and the Consumers Association have been involved.
Who: The Consumers' Association, the Medicines Healthcare Products Regulatory Agency ("MHRA") and various pharmaceutical product manufacturers/suppliers
When: September 2003
The Consumers' Association ("CA") accused the Medical and Healthcare Products Regulatory Agency ("MHRA") (the Government agency responsible for regulating medicines and their advertising in the UK) of being too soft on drug advertising.
This followed the withdrawal of three allegedly misleading drug advertisements within a year. All of the advertising had been for prescription drugs and therefore was directed at medical professionals (direct-to-consumer prescription drug advertising being illegal in the UK and the rest of the EU).
The latest ad to be withdrawn was for the progestogen-only contraceptive pill Cerazette. Manufacturers Organon claimed the mini-pill was as effective as more widely used combined pills. The withdrawal of the advertising followed an investigation by the CA's Drug and Therapeutics Bulletin, which found that Cerazette trial data simply did not support the claims being made.
In another case, a dermatitis cream ad featured a picture of a baby, but had to be withdrawn as it was pointed out that the drug was only licensed for use only with children over 2.
In a separate case involving suppliers Nucare, Numark and AAH Pharmaceuticals case the Medicines Healthcare Products Regulatory Agency ("MHRA") did take regulatory action. This was in respect of alleged breaches of advertising regulations by offering benefits to pharmacists in return for buying products from certain suppliers.
The schemes in question offered pharmacists the opportunity of collecting "points" when they ordered from these particular suppliers. These points could be later redeemed as share discounts or exchanged for travel or holidays.
The companies in question denied that their practices broke the rules, but nevertheless decided to alter their schemes. The MHRA took the position that the points schemes were neither inexpensive nor relevant to the practice of medicine or pharmacy, and therefore came outside the exemptions which gives the green light to modest incentive items such as pens, notepads, inexpensive computer accessories or coffee mugs.
Why this matters:
The CA is currently conducting a campaign against the possibility of the introduction in the UK of direct-to-consumer prescription drug advertising. There can be no doubt that pharmaceutical companies are keen to follow the US example where "DTC" prescription drug advertising has been allowed for some while (although the American Food and Drug Administration is currently coming under pressure to tighten the controls).
For its part, the CA is pressing for a full examination of the implications of DTC advertising both for patients and the NHS. The CA is concerned that as the measure of performance in the pharmaceutical industry shifts slowly from innovation and research to marketing and ultimately profit, the need for regulation and clear, unbiased and accurate information for consumers cannot be under-estimated.
It should be for the MHRA, says the CA, to take a tough line and to closely vet and monitor prescription drug advertising. Time will tell whether the MHRA heeds the CA's advice.
In the case of incentive schemes for pharmacists and doctors, the government's priority is to ensure that health professionals choose medicines on the basis of clinical suitability and value for money, rather than inducements, and the cases in this category indicate that in this area at least the MHRA is taking rigorous steps to ensure compliance.