A legal framework for drug safety

doi:10.1136/bmj.39518.627060.47

BMJ 2008;336 (15 March), doi:10.1136/bmj.39518.627060.47

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Editor’s Choice

A legal framework for drug safety

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

There’s no mistaking the UK regulator’s frustrationat having to drop its attempts to prosecute GSK. Staff at theMedicines and Healthcare products Regulatory Agency reviewedthousands of documents dragged out of GSK over four years. Butin the end the existing EU legislation let them down: at thetime it didn’t require companies to disclose adverse eventsfrom trials in groups of patients for whom the medicine wasnot licensed. On the basis of the same data but in a differentlegal framework, New York state successfully prosecuted GSKin 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 effectsshould be made available promptly in order to protect the public’shealth: "That moral responsibility now needs to be insistedupon 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 moralresponsibility on the drug industry to ensure safety than on,say, the catering or transport industries. Whether there isor not, this case has shown that moral responsibility alonecannot be relied on. Commenting on last week’s other drugindustry story—the successful efforts by the makers ofGaviscon to delay the development of a generic alternative (doi:10.1136/bmj.39517.383484.DB)—Joe Collier says that whateverefforts 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 torecognise that the industry may not have the best interestsof patients or the NHS at heart."

The new UK legislation will remove any remaining doubt abouta company’s responsibility to declare all evidence onadverse effects, whether before or after marketing, on or offlabel, within or outside the EU. In addition, the health secretaryshould undertake a thorough review of the current legal frameworkfor ensuring the safety of prescribed drugs. Legislation similarto the new FDA Amendment Act in the United States, which mandatestimely disclosure of trial results for all drugs and devices(BMJ 2008;336:170; doi: 10.1136/bmj.39469.465139.80), shouldbe enacted across Europe, with additional measures to ensurethat the disclosed data are comprehensive and meaningful andinclude 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. Sofor everyone’s sake let’s rely on the law and makesure it is strong, clear, enforceable, and enforced.

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