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When Is Compliance Necessary?
The pharmaceutical industry has been heavily regulated for many years, starting with the original enactment of the Food and Drug Act in 1906. Over the years, a bewildering array of regulations has been established that affect the sale and consumption of drugs at both the federal and state levels. While many of these past regulations have been subsumed into the FDA's rules and regulations, one of the most difficult and currently pressing questions a pharmaceutical manufacturer must ask itself is whether to comply with California's Proposition 65. The manufacturer's decision to comply may have significant adverse affects on marketing and use of the drug; or conversely, imposition of stiff, costly penalties. This article provides a basic roadmap of the current landscape for compliance with Proposition 65 in the pharmaceutical context.
Background
In 1986, California voters enacted Prop. 65, 'The Safe Drinking Water and Toxic Enforcement Act.' See Cal. Health and Safety Code ' 25249.5 et seq. The purpose of Prop. 65 is to provide individuals in the State of California with information concerning exposures to chemicals that a panel of experts has determined cause cancer, birth defects and/or reproductive harm. Any person or company employing more than ten individuals is subject to Prop. 65, and manufacturers and distributors of products containing listed chemicals are required to 'give a clear and reasonable warning' before exposing anyone to a listed chemical.
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