Monday, 18 June 2007

Biologics Rapidly Becoming New Frontier in Drug Arena

Biologics Rapidly Becoming New Frontier in Drug Arena, FDLJ Article Concludes Monday, 18 June 2007 Dolly was cloned only adecade ago. Since then, there's been an almost cataclysmic revolution in our understanding of biologics, with potentially significant implications for every facet of the health care delivery system in the United States. This awareness of new types of biologics, which now range from universal vaccines for possibly curing cancer, to genetically engineered plants and animals that produce biologics for human or veterinary use, is raising thorny issues for agency regulators, Congressional lawmakers and biotech representatives, such as:

  • How should FDA and Congress define biologics as part of new legislation under consideration that will allow the marketing of "generic"or "follow on" versions and does it really matter?
  • Do we need a whole new statutory or regulatory scheme for defining human and veterinary biologics?
  • How or why do cells, tissues and cloning qualify as biologics?
  • What's the best way to define biologics to accommodate rapid and complex technological advances in the development of new medicines?

In the current issue of the Food and Drug Law Journal (Vol. 62, No. 2), published by the Food and Drug Law Institute, attorney and scientist Edward L. Korwek helps policymakers address these and other issues by offering the most comprehensive, historical analysis to date of the major changes in the statutory and regulatory definitions of human and veterinary biologics in the last 100 years. The FDLJ article analyzes and compares in-depth the criteria for human and veterinary biological product status related to the treatment of infectious diseases, gene and cell therapies, tissue engineering and cloning, among other products of both new and older technologies. Korwek, a senior partner with the law firm of Hogan & Hartson, LLP, in Washington, D.C., notes that while the "regulatory recipes" for human and animal biologics differ in several key aspects, neither covers two critical areas in the drug arena: antibiotics and hormones. The bottom line,according to the article: Regulating innovative technical applications of human and other animal medicines as biologics has become one of the most important challenges facing the drug industry today. .........


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