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Special Communication |

The Safety of Newly Approved Medicines Do Recent Market Removals Mean There Is a Problem?

Michael A. Friedman, MD; Janet Woodcock, MD; Murray M. Lumpkin, MD; Jeffrey E. Shuren, MD, JD; Arthur E. Hass; Larry J. Thompson, MS
JAMA. 1999;281(18):1728-1734. doi:10.1001/jama.281.18.1728.
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The removal of 5 pharmaceuticals from the market in a 12-month period because of unexpected adverse events raised concerns about the adequacy of the drug review process at the US Food and Drug Administration (FDA). Specifically, concerns were raised about improvements in drug review efficiency that significantly reduced FDA review times. We have reviewed the circumstances of the 5 removals to determine whether there was any relationship to the increased efficiencies in the drug review process. When the removed drugs were analyzed by date of approval, no increase in the number of drugs taken off the market was seen, demonstrating that reduced review processing time was not the reason for the cluster of removals. We conclude that the agency's drug review procedures and postmarketing surveillance system after a drug has been marketed are currently adequate but must continually adjust to future challenges.

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Figure 5. Percentage of New Molecular Entities Reaching the US Market
Graphic Jump Location
The percentage of new molecular entities introduced in the United States before introduction in any other country has risen steadily over the last 2 decades.
Figure 4. Rate of Withdrawal of New Molecular Entities
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The trend and differences are not statistically significant. Earlier approval cohorts have had a longer time during which withdrawals could occur, so that future withdrawals from these approval cohorts could alter these results.
Figure 3. Twenty-Year Trends in New Drug and New Molecular Entities Approval
Graphic Jump Location
Figure 2. Distribution of Withdrawn Pharmaceuticals by Year of Approval
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Figure 1. Distribution of Withdrawn Pharmaceuticals by Year of Withdrawal
Graphic Jump Location



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