First, do no harm pg. 5
Currently, all the years it takes a drug to go through clinical trials and approval counts against its 20-year patent life. When the patent expires, competitive generic compounds can join the pool.
Former Vanderbilt clinical pharmacologist Alastair J.J. Wood, M.B., Ch.B., has proposed that the FDA reward pharmaceutical companies that conduct post-marketing studies of their products by lengthening their period of exclusivity—postponing the right of generic knockoffs to compete against them.
Wood, Woosley and others also have called for the establishment of an independent agency to monitor drugs once they hit the market.
In 2005, in response to ballyhoo by physicians, legislators and consumer watch groups, the Department of Health and Human Services announced that the FDA would indeed create a new independent Drug Safety Oversight Board.
Its purpose is to promote a culture of openness and to provide emerging information to patients and doctors about the risks and benefits of medications. The board is composed of FDA employees and various government employees who consult with medical experts and patient and consumer groups.
While this was a step in the right direction, some experts wondered whether it was sufficiently independent or had the authority and resources necessary to do the job.
“Society takes a calculated risk every time we release a new drug onto the market,” Ray notes. “There needs to be someone, some independent authority, in place to make hard decisions.”
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