October 3, 1997
California Mellows Out On Device Regulation
California Governor Pete Wilson signed a new bill into law this week, reducing the regulatory burdens for medical device, biotech, and diagnostics companies operating FDA-registered facilities within the state. The law, AB 764, offers several tangible benefits for California device manufacturers:
- It changes the frequency of California drug and medical device manufacturer inspections from every year to every two years, consistent with current federal law.
- It requires the state Food and Drug branch to accept FDA inspection documents if the federal agency has inspected a facility within two years, thereby eliminating duplicate inspections.
- It removes an outdated state law prohibiting consumer advertising for prescription drugs (and even some OTC drugs), which are now strictly regulated by FDA and FTC.
- It eliminates an outmoded state law that prohibited a manufacturer from using FDA approval in the marketing of the drug or device.
Commenting on the law, David Gollaher, PhD, president of the California Healthcare Institute (La Jolla, CA), remarked, "Since FDA stringently regulates the safety of biomedical facilities, inspections by the state can be redundant and disruptive without improving public safety. This important law halts needless duplications and will allow new medicines and medical devices to reach patients more quickly."
The author of the bill, State Assemblywoman Susan Davis (D-San Diego), agrees, adding that "AB 764 improves government efficiency while ensuring the best possible public health and safety protections." Davis links the law with continued economic growth for the state, noting that "As California's biotechnology industry grows from research and development to manufacturing, we want that production to occur here in California. AB 764 is a step toward securing that production and future growth."
For more information, contact the California Healthcare Institute at 619/551-6677.
