On February 16, 2012, House Representative Brian Bilbray (Republican – California) introduced a bill that would prevent states from requiring drug and medical device manufacturers from undergoing state inspections that duplicate those already required by the Food and Drug Administration (FDA). H.R. 4056 is intended to clarify areas in the Federal Food, Drug and Cosmetics Act (FDCA) by expressly delineating what inspections are governed by the FDA, rather than state public health departments. The bill includes both facility inspections and product recalls.
Currently, California is the only state that requires life sciences companies to undergo both FDA and state inspections by the California Food and Drug Branch. H.R. 4056 is designed to protect drug and device makers nationwide from similar requirements. According to the congressman’s office, there are no discernible differences between California and the FDA’s drug and device inspections. Further, Representative Bilbray asserts that California’s duplicate inspections have cost the state many jobs in the life sciences sector.
The legislation would, however, still allow state officials to investigate complaints that drugs or devices pose a threat to public health and safety. State officials would still be able to inspect facilities after an FDA recall from an in-state facility. Additionally, the FDA would be able to ask state officials to conduct federal inspections, according to the bill.
Supporters of the bill hope that eliminating the redundant inspections will boost the industry’s sagging presence in California. H.R. 4056’s co-sponsors include Susan A. Davis (Democrat – California), and California republicans Mary Bono Mack, Ken Calvert, Jerry Lewis, Edward Royce and Duncan D. Hunter.