FDAnews
www.fdanews.com/articles/84372-uk-cracks-down-on-drug-promotions

UK CRACKS DOWN ON DRUG PROMOTIONS

February 7, 2006

UK drug regulator MHRA has cracked down on companies giving misleading advertising to health professionals after a number of cases of misinformation over the past few months. One drugmaker issued a promotional brochure for a drug, which failed to state the possibility of side effects or serious adverse reaction. The material also did not give adequate information about the safe administration of the product.

In such cases, the MHRA will force the company to withdraw the misleading documents and issue a corrective statement. The regulator published new guidelines for prescription drug promotion in February 2005. These included "naming and shaming" companies that regularly breach codes of practice. The MHRA has increased its powers further in recent months and under the new system all prescription drugs will have to be pre-vetted by the agency before being released, a process that could take three to six months.

However, industry observers have criticised the measures claiming that the checks will lead to delays in approving newly licensed drugs. This comes at a time when the government is keen to introduce a new fact track appraisal system to shorten the period it takes to get a new drug onto the market.