Congressman Brian Bilbray (CA-50) has introduced H.R. 4056, the Science and Technology Regulatory Relief Act of 2012, a bipartisan bill to eliminate a costly duplicative state inspection requirement impacting California's advanced life sciences industry. Business groups have cited overregulation as a key contributor to the state's poor reputation as one of the "least friendly" places to do business in the nation.
To operate in the state of California, drug and medical device manufacturers are required to be inspected by the California Food and Drug Branch (CFDB). According to industry representatives, the inspection performed by the state bear little difference to those performed by the U.S. Food and Drug Administration (FDA), leading the industry to question the need for the additional state inspection. California is the only state that requires inspections beyond those performed by the FDA.
"The path to economic recovery begins with reining in senseless regulations placed on business," stated Bilbray. "This additional inspection not only costs companies hundreds of thousands of dollars, but it diverts limited time and resources away from research, development and innovation."
Companies that have taken part in CFDB inspections have noted that state regulators often rely on data obtained initially by the FDA. "Congressman Bilbray's legislation would serve to end these unnecessary and duplicative state inspections -- saving time, money and resources of both companies and cash-strapped states -- while maintaining protections for patient and public safety and health," stated Todd Gillenwater, Public Policy Senior Vice President of California Healthcare Institute.
While the bill will eliminate the need for a state inspection, it will maintain the partnership between the FDA and CFDB in specific areas:
State agencies would retain authority to conduct facility inspections when it is determined that a drug or device poses a threat to public health and safety,
When the federal government orders a recall of a product manufactured or processed at a facility in state,
Upon direct request of the FDA.
"As a global leader in the advanced life sciences industry, San Diego is disproportionately affected by this unnecessary and costly state regulation. With nearly one in 10 San Diegan's out of work, our advanced life sciences industry is one of the highpoints in the down economy, accounting for more than 24,000 high paying jobs in our region alone," added Bilbray.
Congressman Brian Bilbray serves on the House Committee of Energy & Commerce and is co-chair of the Congressional Biomedical Research Caucus. Energy & Commerce is a standing committee that maintains one of the broadest jurisdictions of any Congressional committee with legislative oversight on communications, consumer protection, energy, environment, and health.