Biologic Manufacturing and the FDA - Essay Example

While most analyses of the U.S. Food and Drug Administration (FDA) focus on the agency's authority to decide which new treatments reach the American marketplace, the FDA plays a regulatory gatekeeper role at another key point in the biological development process. In reviewing investigational new drug applications (INDs), the FDA determines which experimental therapies, vaccines, and other biological products advance from preclinical through clinical development to the licensing phase (Mark). Biopharmaceuticals are licensed under Section 351 of the Public Health Service Act (Mark)and in specific sections of the Food, Drug, and Cosmetic Act.

To obtain marketing approval for a new biologic, an applicant submits a biologics license application (BLA) (Koan and Ellis). The BLA must permit agency reviewers to make four principal determinations:1. whether the biologic is safe and effective in its indicated use and whether thebenefits of using the product outweigh the risks.2. Whether the biologic's proposed labeling is appropriate.3. Whether the methods used in manufacturing and quality control are adequate topreserve the biologic's identity, strength, quality, potency, and purity.4. Whether the biological manufacturing process is capable of producing a productconsistent with the specifications in the application, current good manufacturingpractice (cGMP), and other relevant federal regulations (Mark).

The growth media falls under Federal food, Drug, and Cosmetic Act (the act) and hence, controlled by the same, specifically, if the media is derived from any protein, a label stating the possibility of the media as an allergen should be stated. Elimination of the requirement that FDA (CBER) release each lot of all well-characterized biotechnology products was implemented in December 1995, following the identification of most of the approved therapeutic recombinant DNA products as well characterized (the term "well-characterized" was replaced by "specified products" following the May 14, 1996, Federal Register publication).

The FDA now believes that, once a specified biotechnology product has been approved for marketing and its manufacturing process validated, the manufacturer should be responsible for quality control and assurance that each lot or batch meets established specifications for product release without additional oversight by the agency (Michael). In conclusion, several important aspects of the new (Michael)regulatory paradigm for well-characterized biological products have been implemented and remain permanently in place due to changes that have been effected in the regulations and published guidance documents.

The steps necessary to complete the paradigm shift have been publicly discussed and committed to by the Commissioner of FDA and the Director and Deputy Director of the CBER. All that remains are the details and administrative procedures related to the implementation of the new paradigm which, although a major initiative and resource drain on the agency, will be accomplished to meet the commitments documented in the regulatory and legislative proposals of the mid-1990s (Michael).