If California Rep. Brian Bilbray has his way, state inspections will no longer be required for drugs and medical devices that have already been scrutinized at the federal level.
Bilbray (R-Calif.) introduced H.R. 4056, the Science and Technology Regulatory Relief Act of 2012, on Feb. 16. Its five Republican co-sponsors are joined by a Democrat, Susan A. Davis of California.
As things now stand in the Golden State, manufacturers of drugs and medical devices must submit to inspections by the California Food and Drug Branch (CFDB) regardless of prior review. Bilbray’s office said California is the only state that requires inspections beyond those performed by the FDA.
Business groups have cited over-regulation as a key contributor to the state’s poor reputation as one of the “least friendly” places to do business in the nation, according to a news release from Bilbray’s office. Bilbray’s bill would eliminate duplicate state-level inspections while still allowing state agencies to conduct facility inspections by FDA request, upon product recalls or “when it is determined that a drug or device poses a threat to public health and safety.”
Todd Gillenwater, senior vice president for public policy at the California Healthcare Institute, went on record in support of the bill. Bilbray’s legislation “would serve to end these unnecessary and duplicate state inspections—saving time, money and resources of both companies and cash-strapped states—while maintaining protections for patient and public safety and health,” Gillenwater said in a prepared statement.
Bilbray serves on the House Committee on Energy & Commerce and is co-chair of the Congressional Biomedical Research Caucus.