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M 23: Global Effects of FDA Guidance Requiring Evaluation of Cardiovascular Risk in New Antidiabetic Therapies on Drug Development

Poster Presenter

      Daichi Mori

      • Student, Global Regulatory Science, Pharmaceutical Science
      • Gifu Pharmaceutical University


Our research objective is whether the guidance issued in the US have altered global trends of drug development. As a model case, we investigated antidiabetic drug development status to identify effects of FDA guidance for industry issued in 2008.


Antidiabetic drugs approved during 1990-2015 are categorized into two groups depending on the year of approval, before the guidance (-2008) or after (2009- ). The number of approved drugs, the total patient number participated in clinical trials, and the approval date difference were compared.


Our objective is to investigate about global effects of FDA guidance for industry issued in 2008. Because WHO has reported that “All-America, Europe, and Japan will continue to account for 85 % of the global pharmaceuticals market into 21st century” (Pharmaceutical Industry, glossary of globalization, trade and health terms, WHO), we focused on the US and the other two regions: Japan and the Europe. We analyzed three parameters related to drug development status as describing in Methods section. The first parameter we analyzed is the number of drugs approved because it reflects how advanced the drug development is. The numbers of drugs approved per year after the guidance in Japan, the Europe, and the US was 10.1, 3.1, and 3.3 times more than those before the guidance, respectively. The largest increase was recorded in Japan. The second parameter is the number of patients participated in clinical trials. We chose this parameter due to the paper reporting that the FDA guidance affected on this parameter in the US (Viereck C and Boudes P, Contemp Clin Trials 2011; 32(3):324-332). The patient number in clinical trials of individual drug in the US was significantly increased (p=0.03). This parameter in the Europe or Japan was not. This result shows that the size of clinical trials, defined by the total patient number in clinical trials, significantly increased only in the US. Finally, we investigated the approval date difference, the time lag of drug development between two countries. The approval date difference between Japan and the US before the guidance was 1515 days and that after the guidance was 69 days. The approval date difference was significantly reduced (p=0.04). The approval date difference between the Europe and the US before the guidance was 293 days and that after the guidance was 19 days. The reduction was also statistically significant (p=0.005). From this result, we assume that the issues of FDA guidance might have influenced that states.


In order to investigate global effects of guidance issued by FDA, we selected the field of antidiabetic drug development. In 2008, FDA issued a guidance for industry, namely Diabetes Mellitus- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. As the response to the guidance, Pharmaceutical and Medical Devices Agency (PMDA) in Japan and European Medicines Agency (EMA) in the Europe expressed their own guidelines, different from the FDA’s. We interpreted the antidiabetic drug development trend before and after the FDA guidance in those regions as a global effect of the FDA guidance. Due to the cardiovascular risk evaluation, large clinical trials became inevitable for the approval of new antidiabetic drugs in the US after the FDA guidance. Developing the antidiabetic drugs in the US is more expensive than before the guidance. When comparing the approval date difference, the time lag in Japan and the Europe from the US became significantly small. This result may suggest that pharmaceutical companies pursue simultaneous drug development globally. Particularly, Japan may be the appealing market since developing antidiabetic drugs in Japan does not require large clinical trials. This particular conclusion can be supported by the huge increase in the number of approved drugs after the guidance. Our analysis suggested that a certain guidance issued in the US have affected on the drug development not only in the US but also in the Europe and Japan. This is example of having global effects of a guidance. This conclusion can be drawn because the US has bigger global influence than others. However, it is necessary to be aware of regulatory circumstance globally. Since disease knows no boundaries, a global perspective in drug development and regulatory science is essential.

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