Government to tighten legislation on drug companies

Source: Healthcare Exec

Date :06/03/2008 15:14:26

The government announces new legislation to tighten laws overseeing drug companies.

The legislation follows an investigation by the Medicines and Healthcare Regulatory Authority (MHRA) which found the pharmaceutical giant GlaxoSmithKline had withheld the full results of its trials of the antidepressant Seroxat on children.

According to the four-year investigation, the controversial drug increased the likelihood of suicide among teenagers.

The trial data, which was finally handed to the MHRA in May 2003, identified two problems of which the company had been aware as early as 1998: a higher risk of suicidal behaviour among under-18s using Seroxat rather than a placebo, and that the drug was ineffective in dealing with depressive illness among that age group.

The public health minister, Dawn Primarolo said GSK should have told the MHRA about the results earlier but GSK will not face criminal prosecution because present legislation is insufficiently clear on whether and when drugs companies should inform the regulator.

Tighter legislation

The new legislation will place a greater obligation on companies to disclose the results of clinical trials.

Ms. Primarolo said new legislation will be introduced by the end of the year to ensure drugs companies pass on results of clinical trials as soon as the alarm is raised about one of their medicines.

"Companies that conduct clinical trials should not compromise people's health by withholding information," she said.

In a written ministerial statement published today, Ms Primarolo said: "The process of investigation has revealed weaknesses in EU legislation as it stood at the time, in terms of what safety information drugs companies were legally obliged to provide to the regulators.

"I have therefore asked that immediate steps are taken, as follows: to secure a strengthening of the law in this area, through changes to the EU directive and, in the meantime, amending the law as it applies in the UK; to make it clear to all pharmaceutical companies that, notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health.

The MHRA is writing today both to GSK and to pharmaceutical industry bodies to stress this point," she said.

March 06, 2008