The regulatory scheme for approving pharmaceutical products before they can be sold has long put drug manufacturers at odds with regulators at the Food and Drug Administration. One of the more contentious issues between drug developers and the FDA involves the length of time it typically takes the FDA to approve an application for a new drug. A case now pending in federal court in Washington brings this very issue to a head, as Sandoz Inc., frustrated by not having received a decision from the FDA on a new drug application (NDA) after more than two years, has sued to force the FDA to act.
A drug company, having spent tens of millions of dollars developing and testing a product, is understandably eager to get the product to market as soon as possible. For its part, the FDA has a responsibility to ensure that the product does what it is supposed to do and is safe, so the approval process for a drug frequently takes a considerable amount of time. When the drug under consideration is a generic version of a product that has already achieved FDA approval — and in most cases has been on the market for some time — the equation is further complicated by the fact that the maker of the nongeneric version of the drug has a strong interest in delaying the approval process and has the right to raise issues with the FDA regarding the safety of the generic compound that may have the effect of slowing approval.
