The Regulator’s balancing act

Many patients as well as those in pharmaceutical companies can become frustrated with regulatory agencies when a decision does not match their views. Yet however difficult these regulatory setbacks are to accept, it is important to remember that regulatory agencies are government bodies and are therefore ultimately accountable to the public. For example, in Japan, the cancer drug Iressa (gefitinib) caused a series of adverse events in patients and a number of people died from pneumonia-like illnesses. The country’s regulatory body, the Japanese Ministry of Health, Labour and Welfare (MHLW), was publicly criticised over its role in the approval of the drug. In the US, One of the most damaging episodes for the US Food & Drug Administration (FDA) was Merck’s COX-2 inhibitor Vioxx (rofecoxib), which was withdrawn from the market after being linked to an increase in the risk of heart attacks and strokes.

Public safety is paramount and so decision-making within regulatory bodies must be geared towards this factor rather than external expectations. The European Medicines Agency’s (EMA) own mission statement states the Agency’s intention to “foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public.” The FDA describes its role in similar terms in its Mission Statement.

Ironically, regulatory agencies are often accused in the media of being too “close” to the pharmaceutical industry and have even been sued by consumer groups. Regulatory agencies must constantly find a balance in dealing with the pharmaceutical industry so as to encourage drug development but also demonstrate to those outside the industry that their decisions are impartial and transparent. Reviewers must weigh the information available about a drug’s risk and benefit, make decisions in a limited time in the face of scientific uncertainty, and integrate emerging information bearing on a drug’s risk-benefit profile throughout the lifecycle of a drug, from drug discovery to the end of its useful life. Regulatory processes may have life-or-death consequences for individual patients, and for drugs that are widely used, they may also affect entire segments of the population. Reviewers must therefore strike a delicate balance in judging the drug’s risks and benefits, and whether the need for more information from studies to increase certainty before agency approval, warrants delaying the release of the drug into the marketplace and into the hands of health care providers and their patients.

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