I should have posted this a while ago but became side tracked with my Food Free Trunk or Treat events. I still feel it is pertinent although a bit late; the level of sarcasm is strong with this one…
As we know, Mylan has agreed to pay $465 Million as part of a Department of Justice Settlement for wrongly classifying EpiPen as a generic product. The generic classification allowed the company to pay substantially less in Medicare/Medicaid rebates: “Drugmakers are required by law to pay rebates for sales to patients insured by Medicaid, which is funded jointly by states and the federal government. By classifying EpiPen as a generic, Mylan paid a smaller rebate of 13%, or about $163 million, when it should have been paying a 23% or higher rebate for brand-name drugs, Mr. Slavitt wrote” as noted in the WSJ. It’s too bad the average American consumer isn’t privy to those lucrative rebates–but I digress.
Senator Amy Klobuchar (D.-Minn.) described the mis-classification as an “outrage.” And yes, we should be outraged…but not solely at Mylan.
Why is it that the government is relying on for profit businesses to classify their medications as brand or generic seemingly with no or very little oversight? Don’t look behind the curtain. Nothing to see here. Certainly no conflict of interest to be found (please note the sarcasm). That would be like the FDA allowing generic manufacturers to submit their own documentation regarding equivalency without using an unbiased third party to verify the results. Ummmm, maybe that wasn’t a good example because, that is actually how the FDA rolls.
Why did I just pick on generics? I am a fan of generics in general, however, there have been several generics (specifically generics for Concerta and Wellbutrin XL) that had originally been approved as an A rated equivalent to a specific brand but was later found to actually not be an appropriate substitution; my point in the observation was a common denominator of government oversight or lack there of.
Couldn’t any of the numerous pharmacists employed by both Medicaid or Medicare confirm that EpiPen is, in fact, a brand product? Hell, couldn’t the government actually use its own source, a little publication called the Orange Book, to verify. As a pharmacist, I am forced to use this information daily. DAILY. They could have even accessed the information from any number of tertiary resources such as Clinical Pharmacology or Facts and Comparisons.
Turns out, CMS (Centers for Medicaid and Medicare Services) did know this was happening; interestingly, however, the timeline as to when CMS informed Mylan of the issue is unclear. So, the “outrage” should include Medicare and Medicaid. Forbes reported that “CMS director Andy Slavitt wrote in a letter to legislators that his agency ‘on multiple occasions provided guidance to the industry and Mylan on the proper classification of drugs and has expressly told Mylan that the product is incorrectly classified.'”
Maybe this is just waaaaay too basic but, can’t CMS just correct the classification in its own database. And, if they can’t, why not?
I will not be surprised to read that there are many more medications mis-classified or at the very least participating in massive cost hikes for seemingly no good reason (I’m looking at you insulin). Price gouging and behind the scenes pricing acrobatics should be brought to light, but, let’s focus on the issue as an all-encompassing big pharma issue.
They all play the game.