Are Pharmaceutical Market Withdrawals Preventable? A Preliminary Analysis
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Are Pharmaceutical Market Withdrawals Preventable? A Preliminary Analysis
Drug Information Journal 46(6) 694-700 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512458776 http://dij.sagepub.com
Jaya Sai V. Daggumalli, BPharm, MS1 and Irwin G. Martin, PhD1
Abstract Some drugs have been removed from the market once it had been determined that their risks outweighed their benefits. Withdrawals negatively impact patients using the drugs as well the pharmaceutical companies who devoted tremendous resources to research, development, and marketing. Therefore, there is a desire to minimize drug withdrawals by learning from previous incidents. Hints of the problems that lead to eventual market withdrawal might be found in the initial New Drug Application (NDA). If inappropriate approvals could be prevented, patients’ safety might be protected and withdrawals would not be necessary. Drugs withdrawn between 2001 and 2010 (n ¼ 15) were considered for this investigation. The primary adverse events that led to the withdrawal of these 15 drugs were compared with the data available in the original NDA medical review. From the 15 drugs considered, sufficient information for analysis was available for only 7 drugs. Among the 7 drugs analyzed, the safety data found for 2 particular drugs suggested potential safety signals. Preliminary analyses suggest that the drug withdrawals could not have been predicted for the majority of drugs removed from the market. Keywords regulatory affairs, drug safety, marketing withdrawal, FDA, NDA
Introduction
Methods
Drug development and approval is an incredibly difficult and complex process. Unfortunately, some drugs are withdrawn from the market due to safety concerns or lack of efficacy. According to the US Food and Drug Administration (FDA) statistics published annually in the Center for Drug Evaluation and Research (CDER) reports, after the introduction of the Prescription Drug User Fee Act (PDUFA) in the early 1990s, the annual withdrawal rate of New Molecular Entities (NMEs) due to safety concerns averaged *5% of approved drugs.1 According to the list compiled under the statutory requirements of the Food and Drug Modernization Act (FDAMA) of 1997, there were about 60 drug products that have been withdrawn or removed from the market.2 According to the FDA’s annual CDER reports, a total number of 33 drugs through 2010 have been withdrawn from the market due to safety concerns.3 The history of approvals and safety-based withdrawal of NMEs is summarized in 5-year intervals from 1980 to 2010 in Figure 1. In an attempt to determine if the market withdrawal of discontinued drugs could have been predicted based on the data in the original New Drug Application (NDA), data supporting the individual drug approvals were compared to the reasons for eventual market withdrawals.
Drugs withdrawn in the 10-year period of 2001-2010 were reviewed using the FDA’s MedWatch website.4 Fifteen drugs were withdrawn during this time. Table 1 lists drugs withdr
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