Abstract

Although the food and drug administration (FDA) was not known by its present name until 1930, yet the agency has been active and was created from the Bureau of Chemistry in the Department of Agriculture (FDA.2012). Before FDA was born, the food and drug regulatory agency in the US was operating under the umbrella of the department of Agriculture since 1906 (FDA, 2012). The agency was initially called the Food, Drug, and Insecticide Administration, but the name was changed to food and drug administration in 1930 (FDA, 2003).

The agency has three main divisions that deals with different aspects of regulations; the center for biologics evaluation and research (CBER), center for drugs evaluation and research (CDER) and the center for devices and radiological health (CDRH). However, this article will focus on the evolution, and function of the CBER’s recall enforcement on biologic products, and how the division mitigates the issue.

Divisions of Food and Drug Regulatory Agency

The CBER has been very active in maintaining and regulating whole variety of biologic products. Most importantly, they are active in maintaining the safety of biologic products and initiating proper recalls of any unsafe biologic products. Product recall is one of the most expensive and legally taunting and daunting process. The 2011 and 2012 FDA’s review of biologic recalls shows that most product recalls is due to manufacturer’s labeling error or other manufacturer’s default.

Before the inception of the “CBER”, the agency has been operating in regulating biologic establishments, inspections of vaccine manufacturers, premarket approval of vaccines/other medicinal products, and enacting laws guarding the course of pharmaceutical products (Berger, & Berger, 2012. For instance, the vaccine-contamination scandal from a horse (Jim) triggered the inception of biologics department and the biologics control Act of 1902.

In 1972, the CBER was transferred from the national institute of health (NIH) to the FDA agency (FDA. 2012). The transfer, was followed by a “name” change to the “bureau of biologics”. At the time, the bureau of biologics focused on vaccine allergens and blood products (FDA. 2012). Later on, the CBER became one of the strong divisions of the FDA involved in the biologic product’s assessment. Years later, the CBER expanded the spectrum of their duties to gene therapy, gene clones and other range of biotechnology biologic agents (FDA. 2012).

The recall process is time consuming and very costly both in an economic perspective and healthwise risk assessment. When it comes to safety, the FDA has zero tolerance in keeping any known potential hazardous medicinal biologic products in the market. FDA is obligated to inform the public about a product’s risks and immediately recall default products from the market if a product is known to pose adverse health risk. Interestingly, the 2011 and 2012 recall reports on biologics such as the “Gammagard liquid 10% 20g” recall (product code 1502797, NDC# 0944-2700-06) indicated that most of the products currently under recalls are due to manufacturer’s miscellaneous error and mislabeling issues (FDA. 2012).

Product safety is very important aspect of any regulatory agency’s goal. CBER as they evolve must strengthen their effort in protecting public health from any faulty biologic products. Manufacturers will avoid product default resulting from negligence by ensuring a strict current good manufacturing practices (cGMPs) monitoring oversight. Nevertheless, and first, quality must be designed in a product.

The cGMP initiated by the FDA initiated involves a range of guides on a product’s quality and safety (FDA, 2004). In addition, the CBER division of the FDA proposed and drafted a risk evaluation and migration strategies (REMS) as a standard guide for producing and delivering medical products. Although, the CBER has the responsibility to assess and review a product’s safety, the manufacturer is obligated and required to ensure the quality and safety of a product. Manufacturers must follow the stipulated GMP in order to prevent manufacturer’s error or any consumer’s error resulting from improper labelling of a product. For instance, the Pfizer’s “Prevnar error, 13 Pneumococcal 13-valent Conjugate Vaccine (NDC #:00005-1971-02, Lot #:F73652), is an example of improper GMP (FDA, 2012). This particular recall was initiated by Pfizer in February 10th 2012 because the biologic lot was formulated and filled with expired serotype3 conjugate material (FDA.2012). This recall is currently in progress at wholesale level until September 30th 2013 (FDA. 2012).

George Santayana is right (1905), and it is true, “Progress, far from consisting in change, depends on retentiveness. When change is absolute there remains no being to improve and no direction is set for possible improvement: and when experience is not retained, as among savages, infancy is perpetual. Those who cannot remember the past are condemned to repeat it.” (Scribner’s, 1905, p. 284). Therefore, it is a crucial moment in public health sector for the global regulatory agencies to protect and maintain a safe drug environment in the market, and proactively protect the public health. Moreover, it is an unavoidable greater public service and for the betterment of the health care system for these agencies to be proactive in devising and initiating new methodologies that will enhance the production of safer and quality medicinal products.

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