A Proposal for Radical Changes in the Drug-Approval Process

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Abstract
Drug development is the process by which new therapies are created and brought to market to treat diseases. It is hard to imagine that such an activity would not be universally admired and lauded, but recently the pharmaceutical companies that develop new drugs have been criticized by patients, legislators, and the press.1 This criticism has been focused on the high cost of prescription drugs and the disparity between the costs of these drugs in the United States and in other developed countries such as Canada and the United Kingdom.1 In addition to concern about cost, a more recent issue is the public's loss of faith in the integrity of the industry and its ability to deliver safe and effective drugs. This loss of faith has followed a series of revelations about drug toxicity, which some people have claimed has been hidden from the public and regulators. It has also been suggested that the Food and Drug Administration (FDA), which is responsible for the regulation of new drugs, is not sufficiently stringent.2-4 These are not happy times for pharmaceutical companies or the agency responsible for their regulation. Perhaps, however, this situation provides an opportunity to examine whether changes should be made to the drug-approval process to encourage the development of new drugs with high scientific risk and to provide incentives for studies of the long-term safety of drugs.