Regulatory News

Pharma companies will have to highlight side-effects

Pharmaceutical industry regulation is about to change with a new code of practice. This has been revealed by the Association of the British Pharmaceutical Industry (ABPI) following recent problems with patient safety and the dissemination of data and information of approved drugs, which exposed loopholes within the code.

The new code is a revision of the fundamental outline after consulting the public, and it will be put into practise on 1 January 2006. Under the revised code companies must include prominent information about adverse event reporting mechanisms on all promotional material. A yellow card scheme will be extended by the government to allow patients to report adverse effects of drugs. Definitions on information supplied to patients will be set to give more guidance and to clarify the way that companies may respond to patients' needs for reference information on medicines.

Other measures of the new code include a complete ban on all promotional competitions, a reduction in the permitted number of pages of medicines advertising and the promotion of prescription-only medicines will remain prohibited. A new clause is to be introduced concerning the relationship between companies and patient advocacy groups. The parties are allowed to work together although the involvement of the companies must be made clear and meetings must be arranged in the same way as those for health professionals. Any patient organization that receives financial support from a company must be made into a public list with the terms of the relationship and funding of any significant activity written down in an agreement.

The new code is supported by the Medicines and Healthcare Products Regulatory Agency and the Prescription Medicines Code of Practice Authority, who provide information on their respective websites.

www.abpi.org.uk

GSK's Advair given shortage of breath

Safety warnings have been issued over the best selling asthma drug from GSK. FDA stated that the drug, Advair, and other long-acting beta-2 agonists should detail the serious side-effects, such as a possible increased risk of severe asthma exacerbations and asthma-related deaths.

The restrictions on the asthma treatment were ordered after an FDA examination of SMART trial results of a beta-2 agonist, salmeterol (GSK), which showed that 13 out of approximately 13000 patients died in an asthma-related death. The results for a similar amount of patients taking a placebo showed that only three died. Even though the trial was only conducted on salmeterol and not the combined salmeterol/fluticasone used in the treatment, FDA scientists have extended the same precautions.

The regulatory board has advised that the drug should not be used unless patients fail to respond to low- to medium-dose asthma drugs (e.g., inhaled corticosteroids). The warnings will also apply to Serevent and formoterol flumarate (marketed as Novartis' Foradil), which are other treatments from the company.

The manufacturer has disagreed with the restrictions claiming that they are inconsistent with US National Institute of Health guidelines. The brand is expected to suffer a serious blow because of the new limitations.

www.gsk.com