Education and debateMaking regulation responsive to commercial interests: streamlining drug industry watchdogsCommentary: Concern over drug industry's influence on regulatory policy in EuropeCommentary: Much ado about a good thingCommentary: The freedom …

BMJ 2002; 325 doi: http://dx.doi.org/10.1136/bmj.325.7373.1164 (Published 16 November 2002)
Cite this as: BMJ 2002;325:1164.1

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Making regulation responsive to commercial interests: streamlining drug industry watchdogs

  1. John Abraham, professor (J.W.Abraham@sussex.ac.uk)
  1. School of Social Sciences, University of Sussex, Brighton BN1 9SN
  2. La revue Prescrire, BP459, 75527 Paris cedex 11, France
  3. 191 University Boulevard, Suite 307, Denver, CO, 80206, USA
  4. Church Farm, Bircham Newton, King's Lynn, Norfolk PE31 6QZ
  • Accepted 1 August 2002

Has the pharmaceutical industry skilfully managed to achieve an unhealthy influence over European drug regulatory agencies?

New prescription drugs are developed and tested for quality, safety, and efficacy by the pharmaceutical industry, and little or no drug testing is conducted by governments in modern industrialised countries. Governments have regulatory authorities which have a legal duty to protect public health by ensuring that new drugs are not licensed unless they are of adequate quality, safety, and efficacy (box 1). The thousands of birth deformities and deaths caused by thalidomide focused public and professional concerns on how the commercial interests of pharmaceutical companies may diverge from, or conflict with, the interests of patients and public health. The reasoning behind the creation of new government regulatory authorities in the post-thalidomide era was therefore that they should be “entirely independent” of the commercial interests of the pharmaceutical industry and should act on behalf of the public interest by checking the adequacy of the test data produced by the industry.13 I explain how these government regulatory authorities in the European Union, which were initially established to provide independent scrutiny of pharmaceutical firms in the interests of public health, have become increasingly responsive to the commercial interests of the industry (box 2).

Summary points

After the thalidomide disaster the public expected drug regulation would be independent of the interests of the pharmaceutical industry

In the past 15 years the regulatory agencies have been overly influenced by the industry's desire for rapid drug approvals

Regulatory agencies have become heavily dependent on industry fees for their survival

National agencies now find themselves competing with each other for industry fees for regulatory work

Methods

The arguments in this paper are derived from electronic searches of the medical and pharmaceutical literature, combined with interviews with industry, regulators, and other professionals …

Correspondence to: Christophe Kopp

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