2/06/2009 - A major change in regulation is needed both to improve drug safety and to encourage development of the “drugs we need,” Alastair J.J. Wood, M.B., Ch.B., said during last week's Discovery Lecture.
Drug companies should be guaranteed an extended period of “exclusivity” for developing high-risk, high-need drugs and for demonstrating long-term safety, said Wood, professor emeritus of Medicine and Pharmacology at Vanderbilt and a nationally known expert on drug safety.
“The goal is to make truly innovative, superior drugs more valuable to the people developing them, just as they are more valuable to the patients who are receiving them,” he said.
Wood currently is a faculty member of the Weill Cornell Medical College and a managing director of the biopharmaceutical investment firm, Symphony Capital. His talk was sponsored by the Grant R. Wilkinson Distinguished Lectureship in Clinical Pharmacology, the Division of Clinical Pharmacology and the Department of Pharmacology.
Exclusivity refers to the exclusive right to sell a drug without competition from generic drug manufacturers.
The current period of patent and other protections barely cover the time it takes to develop and test truly new classes of drugs, Wood explained.
The system encourages the low-risk development of copies of existing drugs, while the development of truly new drugs to treat and prevent diseases like Alzheimer's and osteoarthritis go wanting.
Similarly, current methods of assuring drug safety are inadequate.
The U.S. Food and Drug Administration currently can respond to reports of safety problems only by changing the drug's “label,” its published safety profile and indications for use, or by withdrawing the drug from the market.
Yet label changes do not require companies to improve safety, and they are often unseen or ignored by physicians, Wood said.
An example is the diabetes drug Rezulin, which was withdrawn from the market in 2000 after two successive label changes failed to prevent drug-related liver toxicity in patients.
“We need to incentivize long-term safety studies,” he suggested. “If extended exclusivity depended on the demonstration of long-term safety … that would actually make drugs with long-term safety data more valuable than drugs without.”
Wood, a former drug therapy editor for The New England Journal of Medicine, detailed his proposal for “A new approach to drug development” in the Aug. 10, 2006, issue of the journal. It can be found here.©2016 Vanderbilt University Medical Center