| 来源类型 | Working Paper |
| 规范类型 | 报告 |
| DOI | 10.3386/w11425 |
| 来源ID | Working Paper 11425 |
| Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA | |
| Ernst R. Berndt; Adrian H. B. Gottschalk; Matthew W. Strobeck | |
| 发表日期 | 2005-06-20 |
| 出版年 | 2005 |
| 语种 | 英语 |
| 摘要 | In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with speeding new medical innovations to market. These two missions create an inherent tension within the agency and between the agency and key stakeholders. Oftentimes, communications and interactions between regulated companies and the FDA suffer. The focus of this research is on the interactions between the FDA and the biopharmaceutical companies that perform drug R&D. To assess the current issues and state of communication and interaction between the FDA and industry, we carried out a survey of industry leadership in R&D and regulatory positions as well as senior leadership at the FDA who have responsibility for drug evaluation and oversight. Based on forty-nine industry and eight FDA interviews we conducted, we found that industry seeks additional structured and informal interactions with the FDA, especially during Phase II of development. Overall, industry placed greater value on additional communication than did the FDA. Furthermore, industry interviewees indicated that they were willing to pay PDUFA-like fees during clinical development to ensure that the FDA could hire additional, well-qualified staff to assist with protocol reviews and decision-making. Based on our survey and discussions, we uncovered several thematic opportunities to improve interactions between the FDA and industry and to reduce clinical development times: 1) develop metrics and goals at the FDA for clinical development times in exchange for PDUFA like fees; 2) establish an oversight board consisting of industry, agency officials, and premier external scientists (possibly at NIH or CDC) to evaluate and audit retrospectively completed and terminated drug projects; and 3) construct a knowledge database that can simultaneously protect proprietary data while allowing sponsor companies to understand safety issues and problems of previously developed/failed drug programs. While profound scientific and medical challenges face the FDA and industry, the first step to reducing development times and associated costs and facilitating innovation is to provide an efficient regulatory process that reduces unnecessary uncertainty and delays due to lack of communication and interaction. |
| 主题 | Health, Education, and Welfare ; Health ; Public Economics ; Other ; Law and Economics |
| URL | https://www.nber.org/papers/w11425 |
| 来源智库 | National Bureau of Economic Research (United States) |
| 引用统计 | |
| 资源类型 | 智库出版物 |
| 条目标识符 | http://119.78.100.153/handle/2XGU8XDN/569068 |
| 推荐引用方式 GB/T 7714 | Ernst R. Berndt,Adrian H. B. Gottschalk,Matthew W. Strobeck. Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA. 2005. |
| 条目包含的文件 | ||||||
| 文件名称/大小 | 资源类型 | 版本类型 | 开放类型 | 使用许可 | ||
| w11425.pdf（201KB） | 智库出版物 | 限制开放 | CC BY-NC-SA | 浏览 | ||
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