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Administration (FDA) was Merck’s COX-2 inhibitor Vioxx (rofecoxib), which was withdrawn from the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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