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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.
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?
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.
U reference 21 USC 502 but that section has been repealed.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
I looked at 21 USC 352(a which may be applicable and provides as follows: a)False or misleading label
I am still looking for a section comparable to the 502 you cite.
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.
I will look through my files for the additional info required to describe the subject matter you request.
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.
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OK, thanks for your information. You have accomplished for me what I needed.
You are welcome and thank you for the excellent rating.
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?
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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