Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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EpiPen Failures on the Rise Just Like Its Price

EpiPen Failures on the Rise Just Like Its Price | Pharmaguy's Insights Into Drug Industry News | Scoop.it

EpiPens, which contain the hormone epinephrine (also known as adrenaline), are used to stave off allergic reactions that can in some cases kill. Failure of EpiPens to deploy correctly have been cited in seven deaths this year through mid-September, according to reports by patients and physicians made to the U.S. Food and Drug Administration and obtained by Bloomberg News. The FDA received a total of 228 reports of EpiPen or EpiPen Jr. failures during the same time period, according to documents made available as a result of a Freedom of Information Act request. In addition to the deaths, 35 people were hospitalized, according to the reports.

 

Until now, the medical device has been the subject of controversy for a different reason. EpiPen is sold by Mylan NV, a drugmaker legally based in the Netherlands but run from Pennsylvania, that was under fire last year for significantly raising the price of the allergy shot, from about $50 for a single pen to more than $600 for a two-pack. Congress held hearings, government agencies began inquiries, and rival Sanofi sued. The Paris-based competitor claimed Mylan sought “to preserve the monopoly position of their $1 billion crown jewel” by engaging in anti-competitive conduct. Mylan has denied any wrongdoing.

 

EpiPen and EpiPen Jr. failures, meanwhile, resulted in a recall of some units in March by the company that makes the device for Mylan, Pfizer Inc.’s Meridian Medical Technologies. Mylan, which sells the drug-device combo using Meridian’s “pens,” called the defect “extremely rare” (read “A Pfizer Company that Makes EpiPen Devices Failed to Investigate Patient Deaths Says FDA”; http://sco.lt/8L7r8b).

 

Reports submitted by users to the FDA, however, show broadening accounts of malfunctions dating as far back as 2014.

 

More About EpiPen:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”; http://sco.lt/7F88nJ
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”; http://sco.lt/8NWO0H
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”; http://sco.lt/7oM4HZ
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”; http://sco.lt/6WeuSv
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”; http://sco.lt/6lVvf7
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”; http://sco.lt/8tL3kP
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
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Mylan Achieved an ROI of 2.7 by Overcharging Medicaid for EpiPen!

Mylan Achieved an ROI of 2.7 by Overcharging Medicaid for EpiPen! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan will pay $465 million to settle claims that it overcharged states for its signature EpiPen, according to a Thursday Department of Justice press release. The company also signed an agreement with the federal government to enter into a review of its Medicaid pricing practices.

 

For years, Mylan classified EpiPen in a way that forced Medicaid to overpay for the product, according to the Centers for Medicare and Medicaid Services. The company may have overcharged taxpayers as much as $1.27 billion over 10 years, the Department of Health and Human Services’s watchdog organization said in May.

 

Lawmakers slammed the federal agencies on Thursday for letting Mylan get off the hook too easily with the settlement. Sen. Richard Blumenthal (D-Conn.) called it “completely insufficient,” and Sen. Chuck Grassley (R-Iowa) cast is as “disappointing” in statements. Mylan, meanwhile, called the settlement, “the right course of action,” and said that the product has been reclassified under Medicaid as of April 1.

 

[“Mylan ripped off the government big time,” said Public Citizen, “and the U.S. Department of Justice is letting the company get away with it. Mylan misclassified EpiPen in such a way as to provide less generous discounts to Medicaid purchasers than the law requires.

 

Today’s shameful settlement is for barely a third of the amount of the rip-off, and it fails to include an admission of guilt – an appalling omission for a decade-long scheme that enabled Mylan to fatten its bottom line by more than a billion.]

 

Further Reading:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”; http://sco.lt/7F88nJ
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”; http://sco.lt/8NWO0H
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”; http://sco.lt/7oM4HZ
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”; http://sco.lt/6WeuSv
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”; http://sco.lt/6lVvf7
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”; http://sco.lt/8tL3kP
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
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Mylan Execs "Untroubled" by EpiPen Price Increases. Suggest Employees, Critics & Congress Go F**k Themselves

Mylan Execs "Untroubled" by EpiPen Price Increases. Suggest Employees, Critics & Congress Go F**k Themselves | Pharmaguy's Insights Into Drug Industry News | Scoop.it

You might recall EpiPen as last year’s poster child for out-of-control drug prices (read “Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed”; http://sco.lt/5Iy70b). Though this simple medical device contains only about $1 of the drug epinephrine, the company that sells it, Mylan, earned the public’s enmity and lawmakers’ scrutiny after ratcheting up prices to $609 a box.

 

Outraged parents, presidential candidates and even both parties in Congress managed to unite to attack Mylan for the price increases. By August, the company, which sells thousands of drugs and says it fills one in every 13 American prescriptions, was making mea culpas and renewing its promise to “do what’s right, not what’s easy,” as the company’s mission statement goes.

 

So I was surprised when my pharmacist informed me, months after those floggings and apologies had faded from the headlines, that I would still need to pay $609 for a box of two EpiPens.

 

Over the last several weeks, I’ve spoken with 10 former high-ranking executives at Mylan who told me that they weren’t surprised EpiPen prices were still high. Nor were many startled by last week’s developments (read “HHS: Mylan Overcharged Medicaid $1.27B. DOJ: Nothing to See Here, Move On!”; http://sco.lt/5SS2e9).

 

Mylan, they said, is an example of a firm that has thrived by learning to absorb, and then ignore, opprobrium. The company has an effective monopoly on a lifesaving product, which has allowed its leaders to see public outrage as a tax they must pay, and then move on.

 

To understand Mylan’s culture, consider a series of conversations that began inside the company in 2014. A group of midlevel executives was concerned about the soaring price of EpiPens, which had more than doubled in the previous four years; there were rumors that even more aggressive hikes were planned. 

 

In meetings, the executives began warning Mylan’s top leaders that the price increases seemed like unethical profiteering at the expense of sick children and adults, according to people who participated in the conversations. Over the next 16 months, those internal warnings were repeatedly aired. At one gathering, executives shared their concerns with Mylan’s chairman, Robert Coury.

 

Mr. Coury replied that he was untroubled. He raised both his middle fingers and explained, using colorful language, that anyone criticizing Mylan, including its employees, ought to go copulate with themselves. Critics in Congress and on Wall Street, he said, should do the same. And regulators at the Food and Drug Administration? They, too, deserved a round of anatomically challenging self-fulfillment.

 

Further Reading:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”; http://sco.lt/7F88nJ
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”; http://sco.lt/8NWO0H
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”; http://sco.lt/7oM4HZ
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”; http://sco.lt/6WeuSv
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”; http://sco.lt/6lVvf7
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”; http://sco.lt/8tL3kP
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
Pharma Guy's insight:

I told my readers protests wouldn't work a long time ago: “Letters to 'Pharma Sis' to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x

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Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid

Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a move that angered a key Senate lawmaker, Mylan Pharmaceuticals has declined to testify at a planned Nov.30 Senate hearing to review a $465 million settlement the drug maker purportedly reached with the US Department of Justice for shortchanging Medicaid.

In a letter to Sen. Chuck Grassley (R-Iowa), who chairs the Senate Judiciary Committee, an attorney for Mylan explained the company will not appear for three reasons – the “stated focus of the hearing,” because the hearing involves a “pending matter,” because both the Justice Department and the Centers for Medicare & Medicaid Services have already said they will not send officials to testify. The letter was signed by Kathryn Ruemmler, who previously worked as President Obama’s chief lawyer and is now at the Latham & Watkins law firm.

Grassley responded by blasting the feds, as well as the drug maker.

“The Obama Administration is dodging accountability for an expensive problem, and now a company is following its bad example,” he said in a statement. “Taxpayers have paid and [reportedly] continue to pay hundreds of millions of dollars more for the EpiPen than they have to pay. This happened because either the agencies in charge dropped the ball, the company gamed the system, or both.”

“Ironically, the company was eager to talk about this problem a few weeks ago in a press release to investors but not before the United States Senate. It’s a shame government agencies and the company are ducking accountability under a voluntary process. One way or another, I intend to get answers for patients and taxpayers.”

Pharma Guy's insight:

Related article: “Yes, Mylan DID ‘Misclassify’ EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb

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Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide

Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gayle Manchin, mother of Mylan CEO Heather Bresch, helped boost sales of the EpiPen in her position as president of the National Association of State Boards of Education.

 

After Gayle Manchin took over the National Association of State Boards of Education in 2012, she spearheaded an unprecedented effort that encouraged states to require schools to purchase medical devices that fight life-threatening allergic reactions.

 

The association’s move helped pave the way for Mylan Specialty, maker of EpiPens, to develop a near monopoly in school nurses’ offices. Eleven states drafted laws requiring epinephrine auto-injectors. Nearly every other state recommended schools stock them after what the White House called the "EpiPen Law" in 2013 gave funding preference to those that did.

 

The CEO of Mylan then, and now, was Heather Bresch. Gayle Manchin is Heather

In October 2012, Mylan sponsored a morning of health presentations at the association’s annual conference. The presentations included a panel described as being on three of the biggest school health concerns, including food allergies.

 

The presenter at the panel, Chicago-based allergy doctor Ruchi Gupta, received more than $400,000 last year from Mylan for research on which she was the principal investigator, according to Centers for Medicare and Medicaid Services records. The center began releasing drug and device makers’ payments to doctors in 2013, when Gupta got more than $17,000 from Mylan for speaking, education, food and travel.

 

About this time, Mylan launched its "EpiPen4Schools” program, which has provided more than 700,000 free EpiPens to 65,000 schools, about half the nation's schools. The New York attorney general's investigation centers on this program, which required schools to buy EpiPens rather than its competitors if they got discounted versions, but Mylan has since changed the policy.

 

In December 2012, the association announced an "epinephrine policy initiative" designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use," according to a press release that month. The resulting policy “discussion guide” listed key components that school policies and state legislation should have, including protection from legal liability for the school.

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Holy Sh*t! Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!

Holy Sh*t! Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Against a growing outcry over the surging price of EpiPens, a chorus of prominent voices has emerged with a smart-sounding solution: Add the EpiPen, the lifesaving allergy treatment, to a federal list of preventive medical services, a move that would eliminate the out-of-pocket costs of the product for millions of families — and mute the protests.

 

Dr. Leonard Fromer, a clinical professor of family medicine at the University of California, Los Angeles, just promoted the idea in the prestigious American Journal of Medicine. A handful of groups are preparing a formal request to the government. And Tonya Winders, who runs a patient advocacy nonprofit organization, reached out late last month to crucial lawmakers on Capitol Hill.

 

“We can save lives by ensuring access to these medications,” said Ms. Winders, chief executive of the Allergy and Asthma Network.

 

A point not mentioned by these advocates is that a big potential beneficiary of the campaign is Mylan, the pharmaceutical giant behind EpiPens. The company would be able to continue charging high prices for the product without patients complaining about the cost.

 

An examination of the campaign by The New York Times, including a review of documents and interviews with more than a dozen people, shows that Mylan is well aware of that benefit and, in fact, has been helping orchestrate and pay for the effort.

 

The journal article says it was “drafted and revised” by a medical writing consulting firm paid by Mylan, in consultation with Dr. Fromer. And Dr. Fromer himself has served in the last year as a paid Mylan consultant — which he discloses as part of the journal article. The company has also contributed money to many other groups behind the effort, and it has met with them — and Ms. Winders’s organization in particular — to coordinate its strategy, the participants said.

 

The idea being advanced is simple: If the EpiPen makes the federal preventive list, most Americans would have no insurance co-pay when getting the product. That means they could obtain the medication with no direct cost, regardless of its retail price. Mylan could keep the EpiPen at the current price, or perhaps raise it more, while keeping patient anger at a minimum.

 

Instead, the federal government, health insurers and employers would pay the bill. Those costs, in turn, could be passed on to consumers in other ways, as in higher premiums or higher co-pays on other drugs.

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More & More Editorials Call for Drug Price Controls

More & More Editorials Call for Drug Price Controls | Pharmaguy's Insights Into Drug Industry News | Scoop.it

From the Philladelphia Enquirer: Drug makers are entitled to make a profit. But public investment and simple human decency argue that there is a clear public interest to control the price of drugs.

The EpiPen isn't the only example of price gouging. A year ago, Turing Pharmaceuticals raised the price of daraprim, used in the treatment of HIV and malaria, from $13.50 a pill to $750. Following public outrage, it lowered the cost to about $375. Sound familiar?

Sovaldi, a relatively new treatment for hepatitis C, costs $1,000 a pill. That was enough for the Senate Finance Committee to find the cost was unjustified. But little has happened to lower the price.

It's almost remarkable that the Senate held hearings. Among the top contributors to House and Senate campaigns, the health industry has already spent over $160 million on the current races.

Lobbying is even more extravagant. The industry last year spent $500 million, almost half of which ($240 million) came from pharmaceutical and health product companies, according to the Center for Responsive Politics.

In Mylan's defense, CEO Heather Bresch blamed Obamacare noting that people became upset with the price hike because they have high-deductible health care policies. But Bresch failed to note the high cost of health care helps drive the high cost of insurance. Both should be addressed. High deductible policies give consumers a choice of, let's say, spending money they don't have or going into anaphylactic shock. Drugs that can ricochet from $100 to $600 make the consumer's struggle all the more difficult.

Thankfully, several members of Congress are calling for hearings, but those hearings must lead to reining in pharmaceutical costs.

People's health shouldn't be subject to the whims or greed of Big Pharma.

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Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising

Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amid the rising controversy surrounding price increases to $600 or more for its allergy-combatting EpiPen, owner Mylan has drastically decreased the frequency of airings of its "Face Your Risk" commercial, according to research compiled for Ad Age by media research firm iSpot.tv.

 

The 30-second spot, which debuted as part of a larger campaign in late April, features a terrifying scene in which a woman with a peanut allergy accidentally eats a peanut-butter-filled brownie at a party (read “Mylan TV Spot for "FaceYourRisk.com": Doesn't Mention Risk of Not Being Able to Afford EpiPen!”; http://sco.lt/8KWY8f).

 

Since the spot is filmed from the perspective of the victim, viewers see the horrified expressions of other partygoers before glimpsing the bloated and blotchy face of the allergy sufferer in a mirror. Interestingly, the spot makes no mention of the EpiPen, but directs consumers to an awareness website which then leads to a separate EpiPen information website.

 

Mylan has spent $14.7 million running the ad—44% of the company's total 2016 TV spending so far this year -- on the campaign, according to iSpot. The ad ran 326 times the week of July 31. Yet in recent weeks, as the public outcry against Mylan has grown, the spots are appearing less often. Mylan ran the commercial 292 times the week of Aug. 7, 66 times the week of Aug. 14, and has only aired it twice in the last four days, iSpot found.

 

A published list of healthcare awards given in 2015 by DTC Perspectives cites Publicis Lifebrands Evolvr as creating an print ad for EpiPen that made its finalist list. Publicis did not immediately return calls for comment.

 

Initial reaction to the "Face Your Risk" commercial was positive on social media, as many said it illustrated the true and often shocking nature of peanut allergies. Yet sentiment has soured more recently.

 

One healthcare marketing expert said Mylan is not alone in its fearmongering as a way to get consumers on board with its pricey product. John Mack, who runs electronic newsletter Pharma Marketing News, noted that he is seeing an increase in scary ad campaigns.

 

"A trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine," he said.

Pharma Guy's insight:

But has Mylan decreased its EpiPen branded advertising? i.e., its DTC Prespective "award winning" print ads in women's mags?

 

Did you catch my quote at the end of this article?

 

Also read for background: “Mylan CEO Bresch, aka ‘Pharma Sis,’ Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB However, Bresch did not mention THAT in defense of EpiPen’s price increase during her recent CNBC interview. No, she blamed the U.S. healthcare system: “Mylan CEO Bresch Says Healthcare in Crisis No Different Than 2007 Financial Crisis!”; http://sco.lt/6sIX1F

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Mylan CEO Bresch Says Healthcare in Crisis No DIfferent Than 2007 Financial Crisis!

Mylan CEO Bresch Says Healthcare in Crisis No DIfferent Than 2007 Financial Crisis! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bresch argued that the problem of drug prices isn't with Mylan or even the pharmaceutical industry, but instead with a health-care system that often requires consumers to pay not just insurance premiums also out-of-pocket for prescription medications, sometimes to the full retail price. 

 

That phenomenon, Mylan has said, has been exacerbated by the increase in the number of high-deductible health plans. 

"The patient is paying twice," Bresch said. "They're paying full retail price at the counter, and they're paying higher premiums on their insurance. It was never intended that a consumer, that the patients would be paying list price, never. The system wasn't built for that." 

 

"I am hoping that this is an inflection point for this country," Bresch said. "Our health care is in crisis. It's no different than the mortgage financial crisis back in 2007."

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FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.

FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan has raised the price of EpiPen in semiannual 10% to 15% tranches so that a two-pack that cost about $100 in 2008 now runs $500 or more after insurance discounts and coupons. Outrage seems to be peaking now because more families are exposed to drug prices directly though insurance deductibles and co-pays, plus the political class has discovered another easy corporate villain.

 

Still, the steady Mylan rise is hard to read as anything other than inevitable when a billion-dollar market is cornered by one supplier. Epinephrine is a basic and super-cheap medicine, and the EpiPen auto-injector device has been around since the 1970s.

 

Thus EpiPen should be open to generic competition, which cuts prices dramatically for most other old medicines. Competitors have been trying for years to challenge Mylan’s EpiPen franchise with low-cost alternatives—only to become entangled in the Food and Drug Administration’s regulatory afflatus.

 

Approving a generic copy that is biologically equivalent to a branded drug is simple, but the FDA maintains no clear and consistent principles for generic drug-delivery devices like auto injectors or asthma inhalers. How does a company prove that a generic device is the same as the original product if there are notional differences, even if the differences don’t matter to the end result? In this case, that means immediately injecting a kid in anaphylactic shock with epinephrine—which is not complex medical engineering.

 

But no company has been able to do so to the FDA’s satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety.

 

Mrs. Clinton claims the EpiPen price hikes show the need for price controls, and she says she’ll require drug makers to “prove that any additional costs are linked to additional patient benefits and better value.” Somebody in Congress should require the FDA to justify how its delays are advancing the same goals.

Pharma Guy's insight:

Comment from an allergist: What to do?

 

Well, there is a simple fix. Physicians such as I, an allergist, should simply draw up an appropriate dose of generic epinephrine from a vial into a sterile 1 ml syringe, cap the syringe, and give the patient and/or family a quick demo of how to use this in case of a reaction. Send them off with a handout showing the process, for their review.

 

The cost of the syringe and ingredients? About $3. Speaking for myself, I would probably just give it away, and subsume the expense in the consultation charge. Epi is somewhat unstable, so the product would need to be renewed in a few months. No big deal.

 

Now I will hear from lawyers and bureaucrats telling me what an awful idea this is . Go at it, boys and girls (and jerks).

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Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed

Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan pharmaceutical company has a virtual monopoly on EpiPens after a voluntary recall felled their only competitor*, Sanofi’s Auvi-Q, over possible dosage miscalibrations. It’s not the drug being delivered that brings the bucks, though—epinephrine’s a cheap generic. The cost trickery is in the delivery system, the Mylan EpiPen.

 

The EpiPen’s been around since 1977, but Mylan acquired the autoinjector—which precisely calibrates the epinephrine dosage—in 2007. The patient now pays about 400% more for this advantage to receive a dollar’s worth of the lifesaving drug: EpiPens were about $57 when Mylan acquired it. Today, it can empty pockets of $500 or more in the US (European nations take a different approach to these things).

 

According to NBC, Mylan’s profits from selling EpiPens, which they have aggressively, famously marketed with brilliant success, hit $1.2 billion in 2015. That year, Bloomberg reported that the epinephrine-delivery system represented 40% of Mylan’s operating profits. Bloomberg calls Mylan’s marketing of the EpiPen “a textbook case in savvy branding.”

 

It’s what the market will bear, so what’s the problem, right?

 

Only this: Somewhere, right now, a cash-strapped parent or budget-limited patient with a severe allergy will skip acquiring an EpiPen. And someday, they will need it in a life-threatening situation involving exposure to a trigger … and they won’t have it. And they will die. Because they couldn’t afford the delivery mechanism for $1 worth of a drug to keep them alive. Two turning points, a death, and one company at the crossroads.

 

 

Shkreli’s shenanigans earned him the moniker “pharma bro,” but the “bro” in the Mylan case is no bro: She’s ‘pharma sis’ Heather Bresch, now the company’s CEO. The “textbook” marketing plan she hit on expanded the “find” target—one of the three goals of any pharmaceutical company—reaching for parents of children with allergies. The “what-if” fears of parents are a rich vein to tap, one that clearly has proved immensely valuable to Mylan.

 

The “find” was a huge success. And once those parents were found, hitting the second goal of a pharmaceutical company—“start,” as in “start them on your product”—was almost inevitable. The question now is, in the face of prohibitive pricing, syringe-hacking, and all of this negative publicity—in which even Martin “Pharma Bro” Shkreli sees a spot of moral high ground where he can stand—Can Mylan continue to hit that third aim: Keep?

Pharma Guy's insight:

Read “Mylan CEO Heather Bresch: We needed tax inversion in order to grow”; http://for.tn/2bJkNTK

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Bees Hack EpiPen’s Database Of Everyone Who’s Allergic To Bees! What Do They Plan to do with the Data?

Bees Hack EpiPen’s Database Of Everyone Who’s Allergic To Bees! What Do They Plan to do with the Data? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If you or someone you know has a bee allergy, you need to read this right now.

Large consumer data hacks have had devastating impacts on countless Americans, but this recent leak may be the most serious yet: EpiPen’s database of everyone who is allergic to bees has been obtained by bees.

This is absolutely sickening.

EpiPen is scrambling after discovering the breach in its system a few hours ago, and company officials are advising all customers to stay inside until further notice while they figure out just how much data the bees have now. They are also recommending that severely allergic people place towels under their doors and keep their EpiPen primed and hovering just above their thigh with their back to a wall for safety.

“We do not know what they plan to do with it, but we can confirm that bees have a list of everyone who has ever purchased an EpiPen,” reads a prepared statement published on the company’s website. “Bees have your information now. We are very sorry.”

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The "No Generics for You!" Trend - Et Tu EpiPen?

The "No Generics for You!" Trend - Et Tu EpiPen? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Something strange happened when Alice Bers went to the pharmacy earlier this year to fill her son’s EpiPen prescription: The doctor had prescribed the generic, but it would have cost her more out-of-pocket than the branded version.

 

So the pharmacy asked her son’s doctor for a prescription for the brand-name EpiPen, and her health plan got a bill for $438.53, or $227.52 more than the generic would have cost it. Many EpiPen customers, from a range of different health plans, have wound up getting the more expensive brand.

 

“I couldn’t believe how crazy our system is that it cost us less to get the brand name, while of course it cost our insurer more,” Ms. Bers said.

 

The high cost of EpiPens was a red-hot controversy and target of congressional hearings last year, prompting the device’s maker, Mylan, to introduce a lower-priced generic version of the emergency allergy treatment, and rivals to bring their own products to market.

 

But more than seven months after the introduction of the generic, the more expensive brand-name EpiPen still accounts for more than one-quarter of the market, according to Bernstein Research, even though a brand-name drug’s sales usually shrink after low-cost competition arrives.

 

One reason, according to multiple people familiar with the drug industry, is that a middleman can profit from the sale of pricier medicines, such as EpiPen. In the murky world of the U.S. drug-supply chain, higher prices can mean a bigger piece of the pie for middlemen such as pharmacy-benefit managers. There is no way to know exactly how much, however, because the amount a PBM makes is laid out in confidential contracts.

 

“The complexity in the system and lack of the right information available to buyers at the right time costs the country billions of dollars, unnecessarily,” said Michael Rea, chief of executive of Rx Savings Solutions, which sells software to help patients and their employers choose the least-expensive medicines.

 

When Ms. Bers picked up an EpiPen two-pack in March, several companies beyond the drugmaker Mylan were involved in filling the prescription. These middlemen warehoused, shipped and handed over the drug. Overseeing it all was a pharmacy-benefit manager, or PBM.

 

Each was paid for their involvement. For a typical brand-name drug listing for $300, middlemen generally receive more than $37 in gross profit, according to Adam Fein, president of Pembroke Consulting, which advises drug companies on the drug-distribution chain. A PBM gets the biggest share, $18.

 

Further Reading:

 

More About EpiPen:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”; http://sco.lt/7F88nJ
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”; http://sco.lt/8NWO0H
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”; http://sco.lt/7oM4HZ
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”; http://sco.lt/6WeuSv
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”; http://sco.lt/6lVvf7
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”; http://sco.lt/8tL3kP
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
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HHS: Mylan Overcharged Medicaid $1.27B. DOJ: Nothing to See Here, Move On!

HHS: Mylan Overcharged Medicaid $1.27B. DOJ: Nothing to See Here, Move On! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan may have overcharged taxpayers as much as $1.27 billion over 10 years for its signature EpiPens, according to an analysis released Wednesday by the Department of Health and Human Services’s watchdog.

 

The pharmaceutical company has been in hot water for potentially misclassifying its signature epinephrine auto-injector in a way that enabled it to charge a higher price to Medicaid (read “Mylan ‘Gamed the System’ and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj). Because the pens were classified as generic, rather than brand-name products, Mylan paid Medicaid a 13 percent instead of a 23 percent rebate — despite the company being told its classification was incorrect. That allegation came to light in the fall.

 

In October, it was reported that Mylan agreed to a $465 million settlement over these accusations, although the status of this settlement remains unclear.

 

The new calculation of unpaid rebates underscores earlier concerns that taxpayers may get shortchanged by the proposed settlement. As Sen. Chuck Grassley (R-Iowa) noted in a statement, the $465 million settlement is much less than the $1.27 billion Mylan allegedly overcharged.

 

Now the first hard estimate of the overcharging, from the Office of the Inspector General for HHS, reveals that taxpayers may have paid as much as $444 million from 2006 to 2014, and $826 million from 2015 and 2016 — amounting to $1.27 billion in all. Letters from the inspector general stress that these estimates are limited because they do not take into account “supplemental rebates” that individual states may have received.

 

The Department of Justice declined on comment on the settlement Wednesday, saying that “there is no settlement to report.”

 

Further Reading:

Pharma Guy's insight:

Boy! Pharma Sis is lucky Trump won and saved her ass by appointing a do-nothing Dept of Justice (DOJ) leader!

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Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid

Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After weeks of controversy, the Centers for Medicare and Medicaid Services formally blamed Mylan Pharmaceuticals for misclassifying EpiPen with the Medicaid Drug Rebate Program. Under the program, companies must accurately report and pay a rebate on drugs paid for by Medicaid.

“CMS has, on multiple occasions, provided guidance to the industry and Mylan on the proper classification of drugs and has expressly advised Mylan that their classification of EpiPen for purposes of the Medicaid Drug Rebate program was incorrect,” the agency said in a statement. But CMS declined to say what steps are being taken to correct the misclassification.

The statement followed nagging questions about how Mylan classified the emergency allergy device. The company reported EpiPen as a generic, instead of a brand-name, product. This is a significant distinction, because the classifications are used to determine the size of rebates that companies pay Medicaid. Rebates, which are paid in exchange for having their products covered, are lower for generics. For background, read: Did Mylan "Misclassify" EpiPen as "Non-Innovator" to Ripoff Medicaid & Taxpayers?

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Jimmy Kimmel's Mom Makes PB&J for Emmys Audience

Outrage over high drug prices has hit the Emmys. At the awards show last night, comedian Jimmy Kimmel handed out peanut butter sandwiches to the star-studded audience. "If you're allergic to peanuts, uh, well, I guess this is goodbye — because we could only afford one EpiPen," he said. Here's the full clip.

Kimmel was alluding, of course, to the widespread public anger over the cost of the device, which has jumped by 450 percent since 2004. The device's manufacturer, Mylan Pharmaceuticals, will send CEO Heather Bresch to testify before Congress on Wednesday.

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Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!

Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan, lambasted for raising prices, ranks No. 2 in U.S. drug industry in executive compensation

 

The drugmaker buffeted by the furor over hefty price increases on its lifesaving EpiPen had the second-highest executive compensation among all U.S. drug and biotech firms over the past five years, paying its top five managers a total of nearly $300 million, according to a Wall Street Journal analysis.

 

The big pay packages are unusual because of Mylan NV’s relatively small size in the U.S. drug industry, where it is No. 11 by revenue and No. 16 by market capitalization.

 

Companies generally set their executive pay targets relative to peers in their own industry, with larger companies typically offering more generous pay than smaller ones. Pay also varies somewhat with corporate performance.

 

Mylan’s combined total of $292.1 million in pay for its top five executives over the five years ended last December outpaced that at industry rivals several times its size, according to the analysis, including Johnson & Johnson, Pfizer Inc., Bristol-Myers Squibb Co. and Eli Lilly & Co.

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Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear

Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Well, congratulations,Mylan CEO Heather Bresch. You are the new Martin Shkreli, says Ed Silverman, author of Pharmalot.

 

You told CNBC that “we have fought night and day to bring products into the marketplace at affordable prices.” Well, no, you didn’t.

 

As a result, the battle over EpiPen pricing is now the latest proxy for the wider national discussion over corporate profits and affordable health care.

 

To prevent another EpiPen controversy, the government should step in

It’s not too late, though, for you to undo some of the damage. Wells Fargo analyst David Maris suggested you should lower the price to where it was two or three years ago and offer to reimburse families who purchased EpiPen during that time for their out-of-pocket costs. That’s a good idea.

 

Yes, such moves will cost you. But goodwill also has value. And the cost of belatedly displaying empathy may be much less than any laws that emerge as a result of the increasing skirmishes over drug costs.

 

You may think you can ride out the storm, Heather, but what if you’re wrong?

Pharma Guy's insight:

How can you say "Look, I know you have a responsibility to shareholders to maximize profits … and no chief executive wants to disappoint Wall Street" in one breath and then try and convince Bresch - or any pharma CEO - to go the goodwill route? Not going to happen. Pharma Sis and other pharma CEOs are beholding 99% to Wall Street and 1% to patients, IMHO. OK, maybe 95% v. 5%.

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Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?

Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Under fire for aggressively hiking the price of the EpiPen device, Mylan Pharmaceuticals has now lost an influential advocate: Sarah Jessica Parker.

 

The actress said on her verified Instagram account Thursday that she has ended her relationship as a paid spokeswoman for the drug maker “as a direct result” of the price increases. Parker wrote that she is “disappointed, saddened and deeply concerned by Mylan’s actions” and called on the company to “take swift action to lower the cost to be more affordable for whom it is a life-saving necessity.”

 

Parker has been the celebrity face since May of an unbranded ad campaign funded by Mylan to raise awareness of about the risks of anaphylaxis. The EpiPen, which has gone up in price by 400 percent since 2007, is the dominant treatment for the life-threatening allergic reaction.

 

Drug makers often use unbranded campaigns to promote their products without mentioning them by name. One advantage: Image-conscious celebrities are more willing to tie themselves to a campaign focused on raising awareness of a health condition, as opposed to promoting a product.

 

On Thursday, for instance, the drug maker Shire announced that actress Jennifer Aniston will serve as a spokeswoman for an unbranded ad campaign around dry eye — a condition that Shire just happens to have a new drug to treat (read “Jennifer Aniston is Shilling for Shire!”; http://sco.lt/5G686T).

Pharma Guy's insight:

Aren't we all tired of holier-than-thou celebrities that make a deal with the "devil" (for $ mostly) and then get all upset when the devil makes them look bad by acting badly? I know I am! My advice to celebs thinking of shilling for pharma: Just Don't Do It!

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Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen

Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan’s announcement of an expanded discount card system for EpiPens is a false solution that can be summed up as too little, too late.

If the company wants to calm public outrage over its contemptible and unconscionable price spikes for EpiPens, there’s only one course of action: actually lower the price.

Canadian online pharmacies offer EpiPens for a little over a $100 per pen. That would be an excessively high price, but at least within the bounds of reasonability.

Coupons, discount cards and patient assistance programs are a false solution for consumers hit with gigantic out-of-pocket costs. First, many consumers will not use the coupons or the programs. Second, many consumers with high deductibles or no insurance will still need to pay far too much for EpiPens – $300 for a set of two – a problem made worse by the facts that many families purchase multiple sets of EpiPens and that EpiPens must be replaced every year.

Equally as important, coupons and discount cards do virtually nothing to alleviate the rip-off of the health care system, for which all Americans pay as consumers and taxpayers. Because of the opacity in the pharmaceutical market, we don’t know what private and public insurers actually pay for EpiPens, but there’s no question that the price is higher than it would be if Mylan’s retail price were lower.

Mylan’s scheme is a convoluted effort to avoid plain talk about price. It is an excellent example of how corporations are gaming the health care system with elaborate show offers that allow them to continue to price gouge the rest of us.

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Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers

Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Drug company CEO Heather Bresch affectionately describes the humble EpiPen as her “baby,” a once-middling product that she turned into a blockbuster.

 

With aggressive advertising — and even more aggressive price hikes — Bresch has fostered the EpiPen into a bestseller that brings in more than $1 billion a year in revenue for Mylan Pharmaceuticals (read “Pharma Sis, Mylan CEO, Hits Her EpiPen Marketing Target: Moms! Price Gouging Followed”; http://sco.lt/5Iy70b) .

 

But the growing furor over drug pricing threatens to turn Mylan’s biggest asset into a liability. And it has forced Bresch into an unwelcome spotlight, as anxiety over the rising cost of medicine has drug industry critics seeking out the next Martin Shkreli.

 

In the past week, Mylan has faced public scorn, investor skepticism, and castigation from a group of senators calling for an investigation into why EpiPen’s cost has soared fivefold under Bresch’s watch. Even Shkreli, widely perceived as a paragon of greed after hiking a drug price by 5,000 percent, decried Mylan as a group of “vultures.”

 

[Bresch is] one of the drug industry’s highest-paid CEOs, pocketing more than $18 million in cash and stock last year, and sitting at the head of a $26 billion enterprise.

 

 

Pharma Guy's insight:

How Bresch defended herself to her dad: “I said, ‘You know, Dad, we have 5,000 employees in Morgantown, W.Va. — we’re one of the largest employers in West Virginia,’” she told an audience at Fortune’s Most Powerful Women Summit in 2015. “I can guarantee you, if we don’t protect ourselves, no one’s going to protect those jobs.”

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