Changes to Prop 65
Proposed Changes to Prop 65 May Expose Drug and Medical Device Manufacturers to Litigation
|California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed regulatory changes that attempt to clarify warning guidelines for Prop 65 compliance. In its current form, the proposed changes may expose manufacturers of prescription drugs and prescription medical devices to litigation.OEHAA develops a list of chemicals known to cause cancer or reproductive harm that must be labeled on consumer products and business properties. In its current form, Prop 65 deems prescription drugs to be compliant as the FDA already requires extensive product labeling. Prescription medical devices are not mentioned.The new proposal requires prescription drugs and medical devices to clearly identify Proposition 65 chemicals. This is a significant change as companies would no longer be able to use the ‘safe harbor’ warning that is permissible in current law. Manufacturers of drugs and medical devices could be burdened with duplicative labeling and be exposed to new litigation.CHI has convened a task force to oppose these changes. Doing so is critical to protect manufactures from lawsuits and patients from confusing, misleading information.
A side by side comparison of the changes can found on this document, beginning on page 16.
The statement of reasons can be found here – the section on prescription drugs and medical devices begins on page 24.
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To join CHI and have your voice be heard on this issue, contact Molly Ingraham, CHI’s Vice President of Business Development (Ingraham@chi.org or 858-456-8884).