2014-05-04 Lachman CONSULTANTS

19世纪80年代仿制药丑闻开始揭露时，FDA制定了一项行政申请诚信政策。在大约同一时间，立法（1992年仿制药实施法案[GDEA]）规定对某些判有轻罪或重罪的个人给予行业禁令。这意味着将会永远禁止被定罪的个人在医药企业以任何名义直接或间接地提供任何服务。这可以解释为包括受雇于一家制药企业的任何服务（即便是割草这样的工作也不行！）。

在仿制药丑闻期间，有22家刑事定罪的药企，70名被判刑的产业界人士和FDA雇员，以及针对这些组织和个人的5千万美元罚款。最终发生了70项与这些欺骗行为相关的个人禁令，但至今没有一家公司按照GDEA的规定被禁止。

我们来看看过去几年中禁令的数量，我想这会很有意思。

要么是人们在2013年的行为都非常好，要么是2013年的犯罪活动还尚未导致FDA的禁令行动。现在看来大多数禁令针对的，或者是伪造研究记录的临床研究者，或者是参与销售未批准药品的人员，或者是犯有邮件欺诈或其它类型欺诈的人员。这些作奸犯科者中的一位，是FDA CDER新药处的一名化学家，使用FDA内部机密信息参与内部交易（我们都记得这件事 — 我可以说我非常高兴这位犯事者不是仿制药办公室的化学家）。您必须记住，禁令可以是永久禁令或是开放式禁令（通常是5-10年的规定期限）。

即使在经历了过去的教训之后，依然有继续从事非法活动或为了自身或他人利益伪造数据试图钻空子的行为。当提到可能导致禁令的问题时，似乎应验了历史会重演这一趋势。我们需要记住：前事不忘，后事之师。

Lachman CONSULTANTS - Bob Pollock先生 2014-03-27
编译：识林-椒 2014-04-30

Who'da Thunk?
Written by Bob Pollock • March 27, 2014

At the outset of the generic drug scandal uncovered in the late 1980's FDA developed an administrative Application Integrity Policy. At or about the same time, legislation (the Generic Drug Enforcement Act [GDEA] of 1992), provided for debarment of individuals convicted of certain misdemeanor or felony offenses. This meant that an individual that was convicted could be debarred permanently from providing directly or indirectly any services in any capacity to a firm in the pharmaceutical industry. This is interpreted to include any service (including cutting the grass) if employed by a pharmaceutical company.

During the generic drug scandal, there were 22 criminal convictions of drug companies and 70 convictions of industry and FDA personnel as well as $50 million in fines levied against these organizations and individuals. Eventually there were some 70 individual debarment actions relating to the shenanigans that occurred but to date no firm has been debarred under the provisions of the GDEA.

I thought it might be interesting to see what the number of debarments looked like over the last few years.

Either folks were very good in 2013 or the criminal activity conducted during the year has not yet resulted in debarment actions by the FDA. Most of the debarments seen now are either for clinical investigators that have falsified study records, individuals that have engaged in the distribution of unapproved drugs or those that have perpetrated mail fraud or some other type of fraud. One of those debarred was a chemist in FDA CDER's New Drugs Division that was involved in insider trading using confidential inside agency information (we all remember that one – and I can say I was happy it was not an Office of Generic Drug chemist). You must remember that debarment can be permanent or permissive (with a defined period of time usually from 5-10 years).

So even after the lessons of the past, there are some that continue try to beat the system, perform illegal activities or fraudulently create data for their own gain or the gain of others. The saying that history has a tendency to repeat itself appears to be true when speaking of issues that could result in debarment. We need to learn from the past before it is forgotten. If you or you firm are interested in learning more about the generic drugs scandal, how and why it occurred and want to hear some hair-raising stories of that dark period in the generic drug program, please contact Joan Janulis at j.janulis@lachmanconsultants.com and she can arrange for a presentation that will present the facts of this scandal in a way that we hope will make individuals and companies have a new appreciation for doing things right.

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