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Health & Medicine

EpiFail: Gov’t Knew EpiPen Was Misclassified in 2009

— November 14, 2016

As previously reported, Mylan Inc., the pharmaceutical manufacturer of the life-saving EpiPen, misclassified their brand name drug as generic for years, thus deceiving and effectively defrauding governmentally-funded insurance providers Medicare and Medicaid, resulting in millions of dollars in overpayments by taxpayers, all in an effort to save themselves money prior to hiking the price of the dollar’s worth of medicine to $600 per 2-pak in early 2016. In the wake of the massive (and wholly justifiable) outrage over the unnecessary cost increase, Mylan’s CEO Heather Bresch testified before Congress in an effort to rationalize the company’s miserably misguided decision, only to settle with the U.S. Justice Department for a measly $465 million. As stated before, it is estimated their negligence in classifying the drug as generic has cost the general public over $700 million, though the concrete damage figures remain classified. On Tuesday, November 8, it was reported both Medicare and Medicaid were made aware of the misclassification in 2009 by the internal watchdog of the United States Department of Health and Human Services (HHS).

And yet, nothing became of it until 2016.

However, there does appear to be a light at the end of the tunnel, no matter how faint it may appear, as a Senate aid told the press the monetary deal with Mylan has yet to be finalized, meaning it’s possible (though, much as I’d like to believe otherwise, not probable) the pharmaceutical piranha will end up paying a greater fine for their unspeakably immoral misdeeds.

The office of Senator Charles Grassley (R-IA) stated in a press release that Daniel Levinson, Inspector General of the HHS, confirmed the watchdog had, indeed, alerted the Centers for Medicare and Medicaid Services (CMS) in 2009 that the drug was wrongfully labeled as generic, deeming it “problematic.” The Senate Judiciary Committee, which Grassley chairs, will hold a settlement hearing on November 30 to determine the fate of Mylan’s actions, in which Levinson, Mylan, and the CMS have been asked to testify; whether they choose to participate in the hearing remains to be seen.

EpiPen auto-injector; image courtesy of
EpiPen auto-injector; image courtesy of

Speaking to the issue, Senator Grassley said in a statement, “The taxpayers deserve answers on what happened between 2009 and now. It appears the EpiPen was misclassified for years, and CMS was notified of the problem. If no one did anything about the misclassification, why not? This could mean hundreds of millions of dollars in taxpayer over-payments occurred without justification.”

The proposed $465 million came under fire earlier this month after two Democratic Senators and one Republican Senator sent a letter to the U.S. Justice Department calling for a rejection of the grossly lenient fine. Meanwhile, those who must purchase the EpiPen at its continued inflated cost, whether for themselves or their children, remain held financially hostage; for many, it has become a life or death choice, as they can’t afford both the EpiPen and the basic essentials necessary to maintain their previous quality of life.

Both CMS and Mylan have declined to comment on this latest development.

As of today, there is no generic version of the EpiPen and zero market competition, though Mylan has stated they plan to release a generic version of their drug at a cost of $300 per 2-pak in the near future.


U.S. Government Was Informed of EpiPen Overcharging in 2009

U.S. Watchdog Told Medicare, Medicaid That EpiPen Was Misclassified in 2009: Senator

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