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A legal framework for drug safety

BMJ 2008; 336 doi: http://dx.doi.org/10.1136/bmj.39518.627060.47 (Published 13 March 2008) Cite this as: BMJ 2008;336:0

It’s welcome news that the UK government will close the legal loop hole that allowed GlaxoSmithKline to escape prosecution last week for not disclosing evidence of increased suicide risk in children taking seroxat (doi: 10.1136/bmj.39517.500961.DB). But this piece of legislation alone is not enough. It should be seen as just one further step on the legislative road to full mandatory disclosure of data from clinical trials.

There’s no mistaking the UK regulator’s frustration at having to drop its attempts to prosecute GSK. Staff at the Medicines and Healthcare products Regulatory Agency reviewed thousands of documents dragged out of GSK over four years. But in the end the existing EU legislation let them down: at the time it didn’t require companies to disclose adverse events from trials in groups of patients for whom the medicine was not licensed. On the basis of the same data but in a different legal framework, New York state successfully prosecuted GSK in 2004 for persistent fraud (BMJ 2004;329:590; doi: 10.1136/bmj.329.7466.590-d).

In his letter to GSK, Kent Woods, the MHRA’s chief executive, said it should be self evident that information on adverse effects should be made available promptly in order to protect the public’s health: “That moral responsibility now needs to be insisted upon by the unambiguous force of the law.” (www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014153;)

This raises the question of whether there is a stronger moral responsibility on the drug industry to ensure safety than on, say, the catering or transport industries. Whether there is or not, this case has shown that moral responsibility alone cannot be relied on. Commenting on last week’s other drug industry story—the successful efforts by the makers of Gaviscon to delay the development of a generic alternative (doi: 10.1136/bmj.39517.383484.DB)—Joe Collier says that whatever efforts are made to tighten the law or industry codes of conduct, companies will find a way to push their boundaries to the limit: “Doctors, government, and regulators of medicines have got to recognise that the industry may not have the best interests of patients or the NHS at heart.”

The new UK legislation will remove any remaining doubt about a company’s responsibility to declare all evidence on adverse effects, whether before or after marketing, on or off label, within or outside the EU. In addition, the health secretary should undertake a thorough review of the current legal framework for ensuring the safety of prescribed drugs. Legislation similar to the new FDA Amendment Act in the United States, which mandates timely disclosure of trial results for all drugs and devices (BMJ 2008;336:170; doi: 10.1136/bmj.39469.465139.80), should be enacted across Europe, with additional measures to ensure that the disclosed data are comprehensive and meaningful and include the trial protocol.

The drug industry has made progress towards greater transparency, both voluntarily and under pressure from journals and regulators. But there are limits to the force of moral responsibility. So for everyone’s sake let’s rely on the law and make sure it is strong, clear, enforceable, and enforced.

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