This weekly column offers opinions on the latest pharmaceutical industry news.

Among the many questionable tactics Mylan Pharmaceuticals has pursued to boost EpiPen sales has been a surreptitious lobbying campaign to have its device added to a coveted list of preventive services that is maintained by the federal government.

Here’s why this matters: If Mylan succeeds in getting EpiPen on that list, consumers would not have to make copayments, leaving insurers or government agencies to pick up that cost. That sounds like a good deal for patients. But by taking their wallets out of the equation, Mylan minimizes the chance of a public backlash to its pricing. It could likely keep raising the price of EpiPen — largely unnoticed.

This maneuvering, which was first reported by the New York Times, is perfectly legal. But the US Preventive Services Task Force — an independent, volunteer panel of 16 experts — should reject Mylan’s bid and refuse to place EpiPen on its list. The device may save patients from succumbing to life-threatening allergic reactions, but it can hardly be considered a preventive product.

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“I can’t think another instance of where someone has tried to call something that is a treatment a preventive coverage,” said Dr. Virginia Moyer, a vice president at the American Board of Pediatrics and a former chair of the task force. “This effort on the part of Mylan is subverting the process.”

Moyer, by the way, is one of three former task force chairs who recently wrote an essay in the Annals of Internal Medicine that decried Mylan’s subterfuge.

As she noted, task force recommendations are intended to apply to only people who don’t have symptoms of a specific disease or condition. And no prescription medicine has made the list. The task force mostly recommends screening and counseling.

The group does include over-the-counter aspirin on its list, citing evidence that suggests it can decrease the risk of heart attacks and colorectal cancer. Topical eye drops, which are used for preventing conjunctivitis in newborns, made the list, too. On the other hand, no statin is on the list, though millions of people take the prescription drugs to lower their cholesterol in order to reduce the risk of a heart attack or stroke.

Yet Mylan is trying to stretch the notion of “preventive” to include EpiPen.

To accomplish this, the company has funded various patient advocacy groups that are working to convince the task force to add EpiPen to its list. Mylan has met with them to coordinate their efforts, according to the Times.

Another tactic the Times called out: A Mylan consultant wrote a paper — published in the American Journal of Medicine — arguing that “timely” use of the device can prevent a life-threatening allergic reaction. We counted and found that the words “prevent” and “preventive” appear 51 times in the paper, which was drafted by a medical communications firm. (The author’s ties to Mylan and the use of the communications firm were disclosed in the journal).

This is the sort of brazen envelope-pushing that has characterized Mylan’s efforts to boost EpiPen revenue.

Natalia Bronshtein/STAT Source: Elsevier Clinical Solutions’ Gold Standard Drug Database

Earlier this month, the company reached a $465 million settlement for shortchanging Medicaid. For years, Mylan had improperly classified EpiPen as a generic product, instead of a brand-name device. As a result, it got away with paying lower rebates to the government health care program than it should have otherwise, despite receiving repeated warnings from federal officials.

Starting in 2012, Mylan began selling EpiPens to schools at a discount as part of a federal program that offers incentives to stockpile the device. In fact, 11 states require schools to keep EpiPen on hand. But the program also prohibited schools from buying rival devices, which some experts have said may have violated antitrust law. Some lawmakers have called for the US Department of Justice to investigate and the New York attorney general is already doing so.

Management teams are supposed to be focused on profits. And testing limits is human nature. But Mylan executives have demonstrated a well-honed penchant for going too far.

EpiPen pricing is just one manifestation of what is proving to be a larger problem at the company — exploiting taxpayers in the name of shareholder returns, but to the detriment of society at large.

Given the task force’s requirements, getting EpiPen on the list of preventive services is likely to be difficult, as it should be. Certainly, preventing death from allergic reactions is important, but what we really need to prevent is Mylan’s predilection for unfairly boosting its profits by feasting at the public trough.

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  • If this kind of proposal comes to fruition, it would broad day light robbery or something more malicious of the US taxpayer. What would be interesting which senator or congress person would support such a robbery.

    I guess profits before ethics are modus operandi. Cheers.

  • The government has the right to take private property if it is in the public interest.

    Mylan Pharmaceuticals should be seized by eminent domain and resold to a company that will agree to a contract setting a reasonable maximum rate of price hikes.

  • It seems by the Mylan logic that any antidote for a poison would also qualify a a preventive measure. Your stand is the correct one – hopefully it will get the attention it deserves.

    • Mylan is doing nothing different from the lobbying tactics Merck used to push through guidelines that now require 12 year old children in DC, Virginia and Rhode Island to be vaccinated with Gardasil against HPV.

    • May I observe that the real point of dispute is not the pathway but the treatment itself. A vaccine is not given after the onset of the disease – they are preventive by definition.

    • Hi Pharmvet1,

      Yes, although Merck initially tried a surreptitious national effort by enlisting Women in Government, a collection of elected officials, and that backfired. The playbook is the same, in any event, although the Mylan school program may have violated antitrust law, which is a different matter.

      Regards
      ed

  • In the midst of this screaming election, this scheme by Mylan may just slip under the radar. Glad to see your article and agree completely this tactic by a company is not only wrong but also unnecessary. Lobbying for laws that require schools to stock their product is another tactic Mylan has undertaken to fill their coffers under the guise of saving lives. And their recent fine is a drop in the bucket of the profit they made using the wrong classification for EpiPen….why aren’t they required to return all the money they overcharged with interest?

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