Intended for healthcare professionals


Was Committee on Safety of Medicines' advice arrived at lawfully?

BMJ 1995; 311 doi: (Published 16 December 1995) Cite this as: BMJ 1995;311:1640
  1. Andrew H Watt
  1. Director Medicines Assessment Research Unit, Medical School, University of Aberdeen, Aberdeen AB9 2ZD

    EDITOR,--Michael Rawlins seeks to defend the Committee on Safety of medicines' recent advice on third generation oral contraceptives.1 Prescribers should be aware that the committee's published advice may not have been arrived at lawfully because of questions regarding process and whether the advice was disproportionate and beyond the committee's authority.

    Consideration of the issue seems to have been hasty and not based on all relevant data. Spitzer et al's analysis was made available on 9 October and Jick et al's manuscript on 11 October, and members of the committee were given 30 minutes to consider the data on 13 October.2 Rawlins's refutation of “undue haste” is unconvincing. Furthermore, Rawlins suggests that there are three relevant studies. That is incorrect. Farmer et al published a study recently,3 and have subsequently conducted further relevant analyses. The committee does not seem to have considered these data.

    The committee's advice may not be proportionate. The statement in the “Dear Doctor” letter that third generation oral contraceptives should “only be used by women who are intolerant of other combined oral contraceptives”4 does not seem to be supported by the totality of data available to the committee.

    The statutory framework within which the committee exists provides only for its giving advice to the licensing authority. As the committee disseminated advice unconnected to regulatory action it is arguable that it was acting beyond its authority.

    Rawlins has set an unenviable precedent since the committee's advice was not accompanied by licensing action affecting the licensed products referred to in the “Dear Doctor” letter. The licensing authority has a statutory duty to take licensing action on issues of drug safety. Thus in the continuing absence of regulatory action one must conclude that the authority considers that there is no concern over safety. To use Rawlins's phrase, the position is “frankly absurd.” If there is a credible concern over safety the licensing authority should take appropriate licensing action. If the concern is not credible then the committee's advice should be withdrawn. Rawlins was generous enough to “apologise unreservedly” about the manner in which the advice was disseminated. In the continuing absence of licensing action showing confidence in the committee's advice it seems that further apologies are to be expected.

    Recent events suggest that regulatory consideration of issues concerning drug safety in Britain falls short of acceptable standards. An independent inquiry should examine the failures of safeguards in the regulatory system. Improved quality assurance procedures are needed, perhaps including guidelines on good pharmacovigilance. British patients and doctors should not again be subjected to scares over drug safety that arise from processes that seem unlikely fully to have met relevant scientific and legal standards.


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