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Making regulation responsive to commercial interests: streamlining drug industry watchdogs

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journal contribution
posted on 2023-06-07, 19:15 authored by John Abraham
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.1–3 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)

History

Publication status

  • Published

File Version

  • Published version

Journal

BMJ

ISSN

1759-2151

Publisher

BMJ Publishing Group

Issue

7373

Volume

325

Page range

1164-69

Pages

6.0

Department affiliated with

  • Sociology and Criminology Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2012-02-06

First Open Access (FOA) Date

2016-03-22

First Compliant Deposit (FCD) Date

2016-11-15

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