The US has increasingly turned to generic drugs as a key tool in constraining its outlandish health care costs. However, are these drugs as safe and effective as brand name medications? The Supreme Court apparently thinks so since in a recent decision (Mutual Pharmaceutical co. v. Bartlett) it ruled that makers of generic drugs cannot be sued under state law for adverse reactions to their products. The underlying concept is that since the original branded drug has been approved by the FDA and since the generic manufacturer is providing a product that is ‘equivalent’ to the original drug it cannot be held responsible for harm caused by the drug.
Generic drugs now account for 80% of prescriptions and are often 80-90% less expensive than the original branded drug (1). Generics entered the US market under the 1984 Hatch-Waxman Act that provides a rapid approval process (Abbreviated New Drug Application, ANDA) that is far less demanding than the process for approval of the original drug. The generic has to demonstrate ‘bioequivalence’ which is usually interpreted as attaining comparable blood levels to the original drug. However, it is important to realize that the FDA essentially depends on the generic drug producers to provide the data used in the evaluation. Currently the FDA lacks the resources to extensively test all submitted drugs or to inspect all of the factories that produce these agents. Thus, if a generic drug company manipulates the data submitted for approval, or if its manufacturing practices deviate from accepted standards, these problems may not be discovered for a long time. This may be particularly a problem with foreign generic producers, who now account for a substantial share of the US market, but whose operations are difficult for the FDA to monitor. There is a long history of issues with generic drugs due to the lack of efficacy because of insufficient or degraded active ingredient or due to the presence of harmful contaminants. An especially egregious situation involved Ranbaxy Laboratories, an Indian firm that is one of the largest generic manufacturers. Over a period of decades Ranbaxy engaged in outright fraud to obtain approval for its drugs both in the US and especially in many less developed countries with weak pharmaceutical regulations (2).
In this light the Mutual decision seems very problematic. One of the key constraints that keep pharmaceutical companies on the straight and narrow is the fear of litigation. Thus the Supreme Court seems to be opening the door to allowing generic manufacturers to cut back on monitoring the quality of their products and their manufacturing processes. Inevitably this will have harmful effects on patients.