ANDA批准函中的提交日期消失
出自识林
ANDA批准函中的提交日期消失
笔记 2016-04-02 Lachman CONSULTANTS 大约一周前，我开始收到关于仿制药办公室（OGD）批准信格式变化的电话和反馈。最初可能是一个微小变化，令许多企业感到不满，同时也代表了另一个没有警告或不加解释而发生的“透明性”过失。以下是来自2封ANDA批准函开头的句子。阅读这两句话，请看在示例B中缺少了什么。 示例A 示例B 是的，没有了申请的原始提交日期！这意味你失去了精确计算一件ANDA批准时间的能力。FDA做出的一个简单决定，现在你只能尽力去准确地计算其他人提交的ANDA的批准时间。显然，即使是Woodcock医师最初被问及格式变化时也很惊讶。OGD给一个利益相关方的解释是这一变化是为了一致性目的。我们认为这可能意味着与NDA批准函的看起来一致。但认真地讲，如果他们想要一致，为什么不提供NDA的提交日期？在批准函中没有ANDA的提交日期（如果我们足够幸运所有批准新都发布在 Durgs@FDA.gov上）就失掉了企业依赖数年的信息中非常重要的一条。由于申请积压仍然显著，并且企业像疯了一样提供一些他们能够使用的统计指标以确定OGD的进展是变好了还是变坏了，这一点尤为重要。 另外我们在讨论批准函的话题，为什么不是所有的批准函都公布在 Drugs@FDA.gov url 上？大多数ANDA批准函不包含任何机密、商业或贸易秘密信息，因此对于FOI人员应该比较容易能快速修编信件。毕竟，任何一个月发出的批准函没有那么多（虽然每个月的批准量正在小幅度上升），并且还有所有GDUFA招聘，有义务分配给FOI办公室一个或两个执行这项职责的全职雇员（FTE）。 因此，我对于这个问题的观点是，FDA应一致性的报告实际ANDA和NDA提交日期（即，申请被认为已提交的日期），这是应怎样解决“一致性”问题，而不是从所有批准函中去除一条有用的信息。至少，FDA在单方面决定去除这条信息之前应寻求关于这条信息来自利益攸关方的意见。对于批准函公布的问题，很难说什么时候会发生改变，因为像上面说的那样仅公布了如此少的批准函。希望FDA听到我们的呼吁。 Lachman CONSULTANTS - Bob Pollock先生 Do You Notice Something Missing? What the Heck! About a week ago I began getting calls and getting feedback about a change in the Office of Generic Drugs (OGD) Approval letter format. What might appear at first to be a minor change has raised the eyebrows of many in industry and represents yet another “transparency” faux pas that occurred without warning or without explanation. Below are the opening sentences from 2 ANDA approval letters. Read the two sentences and see if you can tell what is missing in Example B. Example A This is in reference to your abbreviated new drug application (ANDA) dated December 23, 2008, submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for ABD Drug Example B This is in reference to your abbreviated new drug application (ANDA), submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for XYZ Drug. If you guessed there is no original submission date for the application, you are a winner! Now that you have won, here is what you lose – you lose the ability to accurately calculate approval times for an ANDA. Yes, that’s right, one simple decision made by FDA and now just try your best to accurately calculate approval times for ANDAs other than yours. Apparently, even Dr. Woodcock was surprised when originally asked about the change in format. The explanation that OGD gave to one interested party was that the change was made for consistency purposes. We think this may mean to be consistent with what the NDA approval letters look like. But seriously, if they want consistency, why not provide the submission date of the NDAs? Not having the ANDA submission date in an approval letter (if we are lucky enough to have the approval letter posted at all on Drugs@FDA.gov) drops out a very significant piece of information that those in industry have counted on for years. This is especially important as the backlog of application is still significant and the industry is working like crazy to provide some statistical metrics that they can use to determine if things are getting better or worse at OGD. And while we are on the topic of approval letters, why aren’t all the approval letters published on Drugs@FDA.gov? Most of the ANDA approval letters do not contain any confidential, commercial, or trade secret information, and thus, it should be relatively easy for the FOI staff to redact the letters quickly. After all, there are not that many approval letters issued in any given month (albeit the number of approval per month is inching upward) and, with all of the GDUFA hires, there is bound to be an FTE or two that has been allocated to the FOI office who can perform this function. So, my take on the issue is, the FDA should consistently report the actual ANDA and NDA submission date (i.e., the date the application is considered submitted) and that is how the “consistency” issue should be addressed, not by taking out a piece of useful information from all approval letters. At a minimum, FDA should have sought advice as to the utility of this piece of information from their stakeholders before making a unilateral decision that eliminates its inclusion. I can tell you it is hard to tell when the change took place because so few approval letters are posted as noted above. Let's hope FDA hears our plea. |