| dc.description.abstract | On September 27, 2007, the Congress passed new amendments to the Food, Drug and Cosmetic Act. These amendments contained numerous changes to the act aimed at addressing the current needs for food, drug, and cosmetic safety. Yet, arguably one area of that law that could potentially have the greatest impact on the safety of many Americans is that containing elements regarding risk analysis. Sections 505-1 and 505(o) contain new rules on how drugs can be regulated in the post-market phase. Key to these rules is the initiation of a system of Risk Evaluation and Mitigation Strategies (REMS). This new system empowers the FDA to require companies to create a plan to address risk concerns of drugs upon initial approval and in the post-approval stage. From the data outlined in this work, it appears that while this law will certainly give the FDA more formal power to force drug companies to investigate and prevent risks, it seems unlikely that the initiation of REMS will lead to radically different behavior on the part of the FDA. The REMS legislation will most likely be another iteration of the FDA’s ongoing attempt to ensure that companies balance risks and benefits. Instead of serving as a means to stifle benefits for fear of risks, the law would most likely result in drugs with significant risks being made available to the subpopulations that most need them. | en_US |
