Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval drug safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. Congress recently overhauled the legislation regarding post-approval drug risk identification, and in doing so made a deliberate decision to put much of the burden of post-approval drug surveillance on the FDA through data mining. Further, the legislation gave the FDA the power to require post-approval clinical trials from drug makers only in limited circumstances. While this arrangement might seem wrong at first, the system, properly implemented, likely represents the most efficient option for risk identification at present. Still, to optimize the system, the FDA and HHS will have to cooperate to ensure that electronic health records are integrated into the data mining prospects. This active post-market risk identification system also has the potential to revolutionize other aspects of drug regulation, like off-label use, and the requirement for pre-approval clinical trials.
Improving Post-Approval Risk Surveillance for Drugs: Active Post-Market Risk Identification,
Mich. Telecomm. & Tech. L. Rev.
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