2015年FDA有多少ANDA和505(b)(2)因请愿延迟？
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首页 > 资讯 > 2015年FDA有多少ANDA和505(b)(2)因请愿延迟？ 出自识林
2015年FDA有多少ANDA和505(b)(2)因请愿延迟？
笔记 2016-08-19 Lachman CONSULTANTS 多年来，原研商使用请愿程序破坏ANDA和505(b)(2)批准过程，并希望推迟FDA对此类申请的批准。由于这个问题，国会被迫通过《2007食品药品管理局修正案》（FDAAA）在《食品、药品和化妆品法案》（FDCA）中新增了505(q)款规定了对请愿的回应审查时限为180天，帮助纠正这一对仿制药、505(b)(2) NDA和生物类似药批准的意外影响。然而，通过FDAAA所做的修改并不足以解决问题。因此，在2012年国会通过另一立法《2012食品药品管理局安全和创新法案》（FDASIA）包含了对FDAAA第505(q)款的修订，以进一步说明FDA如何处理所谓的505(q)请愿，并将回应时限由180天缩短为150天。FDA每年需要向国会提交一份报告说明并提供以下信息：
FDA给国会的2015财年报告 因此，人们可以看到已颁布的法规能够在一定程度上纠正对这些申请类型中任何申请的可能的批准延迟，但人们也可以说对于任一申请的批准延迟（除非真正合理的）即使一个也太多！ 然而，这对FDA仍是一个问题，他们必须在特定的时间范围内回复505(q)请愿。此外，这些回复常常需要占用FDA的大量资源。这些请愿的成功率很低。FDA报告指出，从2008年到2015年，FDA处理了167份505(q)请愿，“截至2015年9月30日，根据505(q)款回复的114份请愿（约68%）被拒绝。另外41份请愿（约25%）部分准许部分拒绝。仅有8份请愿（约5%）获得完全准许。另外4份请愿（约2%）由请愿者自愿撤回。” FDA总结指出，“担心第505(q)款可能不会阻止主要意在延迟竞争药品的批准而并未提出有效的科学问题的请愿的提交。法规要求FDA优先处理这些请愿而不是另外的事项，例如确实提出重要公众健康问题的安全性请愿。其结果是，FDA仍需担心在150天期限内回复505(q)请愿所需的资源是以完成FDA其它工作为代价的。” 我们想知道国会是否与FDA有同样的担心，这样的担心是否会转化为额外的立法以解决这一问题？ Lachman CONSULTANTS - Bob Pollock先生 So How Many ANDAs and 505(b)(2) NDAs Have Had Approval Delayed by Petitions in 2015? For many years, innovators have used the petition process to gum up ANDA and 505(b)(2) approval process and hopefully delay FDA clearance of such applications. Because of this problem, Congress was compelled to pass legislation (the Food and Drug Administration Modernization Act [FDAMA] of 2007) to help correct this unintentional impact on generic drug, 505(b)(2) NDAs, and biosimilar approvals. However, the changes made by the FDAMA were not sufficient to correct the problem. Therefore, in 2012, Congress passed another piece of legislation that contained provisions that modified section 505(q) of the FDAMA to further describe how the FDA is to treat these so called 505(q) petitions. Every year, the FDA is required to submit a report to Congress to describe and provide the following information: The number of abbreviated new drug applications (ANDAs), 505(b)(2) applications, and biosimilar biological product applications approved during the reporting period;
During the fiscal year (FY) 2015 reporting period, FDA approved 492 ANDAs, 45 505(b)(2) applications, and 1 biosimilar biological product application. No approvals for biosimilar biological product applications were delayed because of a 505(q) petition in this reporting period. The approval of one ANDA was delayed because of two 505(q) petitions, and the approval of one 505(b)(2) application was delayed because of one 505(q) petition. During FY 2015, FDA received 15 505(q) petitions. Thus one can see that the statutory provisions already enacted to correct the potential for delay of approval of any of these types of applications has worked to a certain extent, however one could also say that the delay of approval of any one application (unless truly justified) is one too many! However, the issue clearly remains a problem for FDA as they must respond in specific timeframes to 505(q) petitions (see below). In addition, these responses often take a substantial amount of Agency resources. The rate of success of these petitions is very low. FDA reports that, from 2008 through 2015 (the last reporting period), the Agency has received 167 505(q) petitions and “as of September 30, 2015, 114 of the petitions (approximately 68 percent) responded to under section 505(q) have been denied. Another 41 petitions (approximately 25 percent) have been denied in part and granted in part. Only 8 petitions (approximately 5 percent) have been granted. An additional 4 petitions (approximately 2 percent) were voluntarily withdrawn by the petitioner.” The Agency concludes that it is “concerned that section 505(q) may not be discouraging the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues. The statute requires FDA to prioritize these petitions above other matters, such as safety petitions, that do raise important public health concerns. As a result, FDA remains concerned about the resources required to respond to 505(q) petitions within the 150-day deadline at the expense of completing the other work of the Agency.” The complete report can be found here 必读岗位建议：
适用范围： 文件要点总结：
以上仅为部分要点，请阅读原文，深入理解监管要求。 岗位必读建议：
文件适用范围： 文件要点总结：
以上仅为部分要点，请阅读原文，深入理解监管要求。 |
中指出：“在2015财年报告期间，FDA批准了492件ANDA，45件505(b)(2)申请和1件生物类似生物制品申请。在报告期内没有生物类似生物制品申请因505(q)请愿而延迟。有一件ANDA的批准因两份505(q)请愿而延迟，一件505(b)(2)的批准因一份505(q)请愿而延迟。2015财年，FDA共收到15件505(q)请愿。 2008 财年到 2015 财年，FDA 共收到 175 份 505(q) 请愿”