CHPA Supports a Government Standards Defense
Manufacturers and distributors of pharmaceuticals—including nonprescription, over-the-counter (OTC) medicines—face a product liability crisis. As with many businesses, OTC drug manufacturers must spend excessive amounts to defend against the filing and even the threat of frivolous lawsuits, and on excessive insurance costs driven by fears of non-economic damage awards. Yet, these products meet high government standards for safety and effectiveness and can not be marketed unless they go through a rigorous approval process at FDA.
What are OTC medicines?
Consumer healthcare with nonprescription, OTC medicines, is an essential and cost-effective component of our healthcare system. OTC medicines help consumers treat the symptoms of everyday ailments, such as headaches, allergies, colds, and flu. They also help people quit smoking, prevent skin cancer (sunscreens), and eliminate antifungal infections. OTC medicines are used safely and effectively by millions of Americans everyday and are found in nearly every medicine cabinet in America.
Traditional Civil Tort Law Ignores Manufacturer Compliance with Strict Government Standards
In cases where a litigant establishes that a drug has caused injury to a person, and the manufacturer has failed to warn of risk of injury, traditional civil tort law permits that a person recover "compensatory" damages. Compensatory damages may include economic damages such as medical expenses, lost wages, and may also include non-economic damages for pain and suffering.
In addition, courts and juries have allowed individuals in some situations to collect "punitive" damages. Traditionally, in order for plaintiffs to recover punitive damages, they must prove that a manufacturer engaged in malicious or wanton behavior. With respect to OTC medicines, punitive damage claims can be filed even though the manufacturer’s conduct is regulated, reviewed, and in accordance with standards set by FDA. Thus, even when a manufacturer in good faith has met all relevant government standards for health and safety, there remains the possibility that punitive damages could be awarded.
Nonprescription Drugs Face Strict Government Standards
OTC medicines enter the marketplace through two methods:
- New drug application (NDA). As with prescription NDAs, the Food and Drug Administration evaluates the safety and effectiveness of new OTC medicines through an extensive, data-driven process involving a thorough scientific evaluation by FDA experts before the drug can be marketed. Typically, such drugs have prior marketing experience in a prescription version. OTC medicines must also include labeling necessary for safe consumer use – labeling which is increasingly tested and reviewed by FDA to assess its effectiveness in delivering needed consumer information.
- OTC Monographs. Since 1972 the FDA has been involved in a massive undertaking—the OTC Drug Review—to ensure that all OTC medicines on the market are safe, effective, and properly labeled. The OTC Review is a program of regulatory thoroughness unparalleled in the Agency’s history. The OTC Review is, therefore, an administrative mechanism that serves as an "approval process" by which all OTCs are evaluated based on the safety and effectiveness of their ingredients. Because OTC medicines are used directly by consumers, FDA generally applies a higher standard of safety than for medicines limited to prescription by medical professionals.
Congress Should Act This Year to Allow a Government Standards Defense Against Punitive Damages for FDA Regulated Products, Including OTC Medicines
Those who manufacture and sell OTC medicines that comply with government standards should not, absent proof of fraud or malfeasance, be held liable for punitive damages, which result from the use of these products.