The EMA has launched much stricter rules for its experts’ interactions with the drug industry. The agency’s new guidance on conflicts of interest says people who have interests in a company will have their work with the agency restricted. The policy is due to come into efect next year.
BMJ 2010, 341, c5902
The coalition governement has dropped plans to introduce the automatic substitution of generic drugs in primary care in England.
BMJ 2010, 341, c5780
Executives of drug companies could face criminal charges if companies promote the off-label use of drugs, says an attorney for the US Food and Drug Administration. This aims to move away from fines to companies which does not currently seem to act as a deterrent for companies.
BMJ 2010, 341, c5808
Tesco has been granted permission to sell sildenafil (Viagra) in 300 pharmacies in its supermarkets without the need for a prescription from a GP. The Medicines and Healthcare Regulatory Agency confirmed that sildenafil remains prescription only and that Tesco has been granted permission to dispense the drug uder a special licence called patient group direction. These licences are granted in situations where they offer an advantage to the care of patients without compromising their safety and where they provide an opportunity for general health screening.
BMJ 2010, 341, c5294
On September 22, the European parliament agreed new legislation on pharmacovigilence. Under this new system, national web portals will be established to provide the public with information on medicinal products and any known side effects. The portals will contain assessment reports, summaries of product characteristics and information leaflets. They will be linked to the EU’s EudraVigilance database.
BMJ 2010, 341, c5344
Boehringer announce that it is withdrawing its drug, flibanserin, for increasing femal sexual desire, from development. The company made the announcement after negative reviews from the US Food and Drug Administration.
BMJ 201, 341, c5701
There is concern that trade negotioations and industry lobbying will threaten the flow of affordable generic drugs to developing countries. A study in Journal of International Aids Society (2010, 13:35) shows that 91% of all antiretrovirals for children are Indian generics. However, the study warns that the free trade agreements that India is negotiating with the EU may increase the price of the antiretrovirals.
BMJ, 2010, 341: C5135
Powered by WordPress