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Richard - Bizlaw
Richard - Bizlaw, Attorney
Category: Business Law
Satisfied Customers: 8684
Experience:  30 years of corporate, litigation and international law
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This is for Bizlaw please. I notified the FDA in 2002 of

Customer Question

This is for Bizlaw please.

I notified the FDA in 2002 of the defendant's fraud that it used in 44 instances throughout its New Drug Application for its drug. The FDA ultimately agreed that it was fraudulent as I had reported. I reported it strictly as a concerned citizen and not as a relator of a qui tam or for any litigation purposes at all. I just wanted them to do something about it through enforcement actions. The FDA reacted by taking the information out of all publicized literature as of 2004. As a result of the action the FDA took in agreeing that the NDA was in fact fraudulent, caused the drug to be labeled by FDA law as a misbranded drug and therefore not eligible for reimbursement through Government programs such as Medicare and Medicaid. Six months ago I was researching another unrelated situation involving another drug and found that under FCA laws misbranded drugs are in fact a fraud upon the government when submitted for payment or approval for payment. Each prescription submitted is a separate instance of fraud. In fact, every prescription ever submitted to the Government for reimbursement of this drug is a fraud, some 3-million to date. I have a six year statute of limitations running backward from about Feb of 2013 when I first realized the fraud on these reimbursements had occurred and was obligated to timely file a qui tam with the Government in order to stop the ongoing monetary damages to the Government and the resulting fraud itself. Since I am the only person that can track back to the original disclosure being made the to Government in my email contact with the FDA it seems I should be able now to file as the relator and original source of this new concept which again I have uncovered which is on going fraud that is damaging the government without being checked or ended. I would be bringing to the government for the first time without any public disclosure of any kind being made a multi-billion dollar ongoing fraud that will surely continue if it is not brought to the government's attention through a qui tam action where a recovery of damages is possible. You should analyze this as though I am the original source of the new information I am bringing forward, I am the relator, I have direct knowledge of the fraud, the Government is totally unaware of this continuing fraud, it was my actions back in 2002 that caused the drug to become a misbranded drug. I do not intend to claim any thing of wrong doing past 2007 or 6-years to stay well withing the FCA SOL. I only describe my original reporting to the FDA as that of a concerned citizen's report, nothing else except that my report, unbeknownst to me at the time, caused the drug to become misbranded. At first glance and assuming a lot of the last sentences to be true, which it is, do you see any reason I should not qualify for this qui tam action as a relator?
Submitted: 12 months ago.
Category: Business Law
Expert:  Richard - Bizlaw replied 12 months ago.

bizlaw :

Hello, I will try to help you. Please remember I just report or interpret the law, so the outcome may not be what you hoped for.I will review in the morning and get back to you.

bizlaw :

I am not clear on something. if the drug was misbranded and then is properly branded, does its proper use still meet FDA standards for use of the drug once correctly branded? For example if the product was branded to treat disease A. The FDA finds that it does not treat disease A but does treat disease B. Since the misbranding was discovered is the drug being prescribed and paid for treating disease B or is it still be used to treat disease A?

Customer :

The drug is misbranded for all uses under FDA 21 U.S.C. section 502(a) stating that an NDA approval that is based upon fraud causes the approved drug to be misbranded for all indications. The drug cannot be rebranded or brought back into branded status unless and until the pharma resubmits a new NDA that corrects the fraud and other misrepresentations the original NDA contained. That has not occurred thus the drug remains misbranded for all uses. FDA 21 U.S.C. section 331(a)(b)(c) states that a misbranded drug is ineligible for utilization in government reimbursement programs. The Defendant continues to submit and cause others to submit prescriptions of the drug to the Government Medicaid and other programs for payment. But as for the misbranded status getting cleared up it will take some type of qui tam or governmental action to correct this wrong.

bizlaw :

U reference 21 USC 502 but that section has been repealed. Is there another section that discusses the impact of fraud on misbranding for all purposes

bizlaw :

I looked at 21 USC 352(a which may be applicable and provides as follows: a)False or misleading label


If its labeling is false or misleading in any particular. Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved under section 355 of this title or under section 262 (a) of title 42 for such drug and is based on competent and reliable scientific evidence. The requirements set forth in section 355 (a) of this title or in section 262 (a) of title 42 shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request. In this paragraph, the term “health care economic information” means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.
bizlaw :

I am still looking for a section comparable to the 502 you cite.

Customer :

the drug is sufficiently misbranded under 21 USC 352a I think for the purposes of this argument which would have the drugs status reach the misbranded bar.

Customer :

I will look through my files for the additional info required to describe the subject matter you request.

bizlaw :

If I assume you are correct that prescriptions of this drug should not be paid for by medicare then I think you have a good case to proceed. The critical issue is that medicare should not be paying for the drug. You must be able to establish that under either a recognized theory of the law or one that has a reasonable chance of being adopted.

bizlaw :

If I have answered all your questions, please rate my answer excellent as that is how I am compensated. If you have more questions, please let me know. If the answer was especially helpful you can provide a bonus.

Customer :

OK, thanks for your information. You have accomplished for me what I needed.

bizlaw :

You are welcome and thank you for the excellent rating.

Richard - Bizlaw, Attorney
Category: Business Law
Satisfied Customers: 8684
Experience: 30 years of corporate, litigation and international law
Richard - Bizlaw and 4 other Business Law Specialists are ready to help you
Customer: replied 11 months ago.

bizlaw:


 


I have one other thing to ask of you, you mentioned that 21 502 had been repealed but I can only find where 502 (d) was repealed. Would you please share with me if indeed you found the total 502 repealed or just this section sub-set 502 d?

Expert:  Richard - Bizlaw replied 11 months ago.

I went to an online listing for the US Code. Here is the link showing 21 USC 501-517 being repealed. http://www.law.cornell.edu/uscode/text/21/chapter-11

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