Free Paper Sample on Risk Evaluation and Strategies

Introduction

Risk evaluation and mitigation strategies (REMS) is a safe drug program used by the United States Food and Drug Administration (FDA) to regulate drugs with safety concerns; they ensure that the benefits outweigh the risks. On the other hand, Risk Minimization Action Plan (RiskMAP) is applied to ensure minimum risk while preserving the benefits (Frost, 2009). Recently the president signed a policy entitled the Food and Drug Administration Amendments Act of 2007 (FDAAA) that requires individuals to submit a proposed REMS amid releasing a new product. Before the act was approved, RiskMAPs were used to develop strategic management plans for drugs that needed additional risk management (Frost, 2009). The paper evaluates the added value of the recommended REMS program.

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Timetable Schedules

The FDAAA recommends that all submission timetable schedules for REMS must encompass an assessment 18 months and three years after the new strategy is approved; also, an evaluation in the seventh year amid approval of REMS (Frost, 2009). Other elements added to make the program effective include a medication guide provision for each drug, a patient package that aids in mitigation of serious risks posed by the drug, and a communication plan to enable consumers to contact health care providers if the need arises. Elements to ensure safe usage (ETASU) of the drugs; the FDA requires every drug to meet the requirements before application (Frost, 2009).

Hazard

Any product that poses more risks than benefits to human health is a health hazard. Thus, it is ideal that programs are given the government’s mandate to control drugs’ usage. The program provides a platform where government programs can share various medication producers’ ideas for consumers’ common interests. The recommended proposals in the act of FDAAA gave the producers a chance to be a part of the regulation program, which was a challenge during the RiskMAPs application era. The requirements required by the FDA regarding ETASU give every drug manufacturer a chance and, at the same time, works on the benefit of consumers. Regular assessment of drugs is useful in ensuring that the drug maintains its quality as per FDA regulations.

Conclusion

Thus, the idea of medication guide and communication contacts is vital in preventing misuse and misinterpretation of instructions provided by the manufacturer, ensuring consumer safety. It is ideal to note that the value added to RiskMAPs to formulate the REMS program is beneficial for all parties involved, including the FDA, producers, and consumers.

Reference

Frost, K. (2009). Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications—Guidance for Industry. Biotechnology Law Report, 28(6), 755-773. https://doi.org/10.1089/blr.2009.9895.