The Washington Examiner cited the Competitive Enterprise Institute on the direct toll to human life that regulations impose as a result of ever-increasing FDA clinical demands creating a bottle-neck process in the pharmaceutical market.
Under the current model, even before the most promising drugs are permitted to enter the three-phase clinical trials, they must pass the FDA’s preclinical trial phase. This can take up to six years and requires the submission and approval of an Investigational New Drug application.
While drugmakers work their way through the FDA’s approval regime, people die and/or suffer in the interim. How many? Sam Kazman, general counsel at the Competitive Enterprise Institute, estimated in the Journal of American Physicians and Surgeons that hundreds of thousands of lives have been lost due to ever-increasing FDA clinical demands. Resources that pharmaceutical companies must use to move a drug through the bottleneck approval process are resources that cannot be used to conduct additional research and development of other promising treatments.
Because the average cost to bring a new drug to market now exceeds $2.5 billion and may take longer than a decade, pharmaceutical companies will often only put those drugs into the approval pipeline that have a comparably low risk of being rejected by the FDA.