Issues Facing Development of New Innovative Medicines
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DRUG DEVELOPMENT
profitability, intellectual property rights, user fees/FDA accountability, congressional scrutiny, direct-to-consumer advertising, postmarketing surveillance, pharmacogenomics, and so on. All of these elements present additional complexities that will need to be addressed to ensure the continued flow of and access to new lifesaving products as well as those that improve quality of life. It is clear that changes are needed to solve these complex problems; the challenge is to ensure that these changes ultimately benefit the patient. In a Business Week article published last year, Gary S. Becker, Nobel Prize Laureate, pointed out that “New drugs have the potential to cut the growth of medical spending sharply. It is crucial to take much better advantage of this potential” (2). RISK VERSUS BENEFIT Dr. Kaitin opened the discussion by saying that, “There is a public perception that drugs may not be safe, that the process is broken in some way.” The industry, and sometimes the FDA, has been severely criticized when adverse events emerge following introduction of new products, particularly when those events are serious and lead to product withdrawals or new warnings. Dr. Kaitin shared data showing that the number of products withdrawn for safety reasons from 1980 through 2004 remained low and relatively constant, despite a trend downward in approval of new molecular entities (Figure 1). These data are supported by information included in the Center for Drug Evaluation and Research 2004 Report to the Nation (3). The “speed”of the FDA review as mandated by the Prescription Drug User Fee Act (PDUFA) has, at times, been cited as a potential reason for the entrance of drugs into the market that resulted in harm. The time required for FDA review of new marketing applications is similar to that of other major regulatory bodies around the world. Dr. Antony noted that in actuality no more drugs have been withdrawn from the market during the PDUFA era as were withdrawn previously. The total number of drugs withdrawn from the market for safety reasons represents only a small fraction of those marketed, and that
Yqer, Starrett
fraction has not significantly increased over the years (Figure 2). Although the data do not support a conclusion that drugs are more dangerous today than in the past, public perception remains that an increasing number of unsafe drugs are being allowed to reach the market. The news media may be contributing to this perception. Joanne Silberner not only acknowledged that the media does play a role in shaping public perception, but also pointed out that the media is very much at the mercy of news events (e.g., drug withdrawal followed by congressional hearings). The authors and most others would agree that fair and balanced reporting is essential to ensure that the public is informed and not inappropriately alarmed. However, it must also be recognized that there are limitations to the breadth and scope of information that can be presented via the media and the amount/complexity of the informat
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