CA Wants to Dump State Drug Plant Inspections to Save Money

CA Wants to Dump State Drug Plant Inspections to Save Money

February 27th, 2012 // 1:38 pm @

Source: Pharmalot

In a bid to eliminate what were described as “senseless regulations,” a California congressman has introduced a bill to prevent any state from requiring inspections of drug or device facilities that, essentially, would duplicate inspections that are already required and conducted by the FDA.

The bill was introduced by Brian Bilbray, a Republican who serves on the House Committee of Energy & Commerce and argues the legislation would save the state money and industry money, and could also lead to faster job growth. The California Food and Drug Branch, he maintains, conducts inspections that are similar to what FDA inspectors pursue in plants and warehouses.

“The path to economic recovery begins with reining in senseless regulations placed on business,” Bilbray says in a statement. “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.”

The mission of the California Food and Drug Branch is to “protect and improve the health of all California residents by assuring that foods, drugs, medical devices and certain other consumer products are safe and are not adulterated, misbranded nor falsely advertised; and that drugs and medical devices are effective,” according to its web site (see this). We asked the state agency for comment and will update you accordingly.

The bill, which you can read here, would amend the Food, Drug and Cosmetic Act, but would also create some exceptions. For instance, state agencies could conduct inspections when a drug or device is believed to pose a threat to public safety, when the FDA orders a product recall or if the FDA made such a request.

In the current campaign cycle, by the way, the pharmaceutical and health care industries were the third-largest contributor to his treasury – $52,750, mostly from political action committees, according to the Center for Responsive Politics (look here). Among them was the American Health Care Association and Abbott Laboratories.

[UPDATE: Late Friday, Feb. 24, a spokesman for the California Food & Drug Branch sends us a lengthy explanation:

1. What is different about inspections of drug and medical device manufacturers conducted by the CDPH Food and Drug Branch and those conducted by the FDA?

California’s drug and medical device industry is subject to the primary oversight of two distinct regulatory agencies whose responsibilities and activities are primarily complimentary. The FDA and the CA Department of Public Health’s Food & Drug Branch have different missions and regulatory philosophies, and the breadth and scope of daily activities by their respective personnel are unique to each.

cfdb-chart-part-oneBesides the obvious distinction that, jurisdictionally, the FDA is a federal government agency and FDB is a state, each must operate pursuant to two different bodies of law, both of which were promulgated to ensure that the drugs and medical devices made in California are of the highest quality, safe and effective for their intended use.

cfdb-chart-part-twoWhere the federal FDA focuses essentially on the general approval and protection of the nation’s supply of both traditional and novel drug and medical device therapies, FDB primarily seeks to ensure that only reputable and legitimate manufacturers of these drug and medical devices operate within this state. FDB and FDA conduct routine work planning sessions to ensure that work is not duplicated by the agencies and that the industry is more fully monitored. FDB and FDA communicate on complaint and injury notifications received to ensure that one effective response is initiated, rather than two separate responses by the respective agencies.

cfdb-chart-part-threeFDB requires that every drug and medical device manufacturer (including those manufacturing experimental or investigational new drug and medical devices to be used in human clinical trials) be subject to a facility licensing program prior to initiating operations in California. California Health & Safety Code (H&SC) reads as follows:

“111615. No person shall manufacture any drug or device in this state unless he or she has a valid license from the department. The license is valid for two calendar years from the date of issue, unless it is revoked. The license is not transferable…

111620. A separate license is required for each place of manufacture.”

2. What does FDB staff do during an inspection of a drug or medical device manufacturer?

During an inspection, FDB staff enforce provisions of the Sherman Food, Drug & Cosmetic Law (California Health & Safety Code section 109875 et. seq.) to ensure drug and medical devices are not adulterated, misbranded or falsely advertised. The inspectional process by FDB staff includes the verification of ownership, adequacy of the facilities, and personnel qualifications to ensure conformance with statutory requirements.

FDB license inspections provide benefits to both manufacturers and consumers by ensuring that manufacturers comply with design, testing standards, and all applicable California Health and Safety Code requirements prior to distributing drug and medical products into commerce. As these products are being used to treat life-threatening diseases or are necessary for life-support, FDB inspections prevent product contamination, misbranding, and a variety of formulation, fabrication, and labeling problems.]

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