Mylan CEO says EpiPen controversy was “a window into a broken system”

The head of the pharmaceutical giant Mylan is speaking out about the firestorm created by the nearly-500 percent increase in the price of EpiPens. Mylan CEO Heather Bresch was called to testify before Congress last year about the huge price increase for the life-saving allergy medicine to $600. After the controversy, the company cut the list price of generic EpiPens to $300. In an interview with “CBS This Morning” co-host Norah O’Donnell, Bresch said bigger change is needed to fix what she calls a broken healthcare system. “You took it on the chin this summer. Before Congress and in the public,” O’Donnell said. “I did,” Bresch said. “And now you’re calling for change, and you’re talking about pharmacy benefit managers, insurers, wholesalers, pharmacy retailers, asking for transparency,” O’Donnell said. “I mean, that’s inviting more controversy.” “Look, I’m inviting change,” Bresch said. “And like I said, that can be – it’s not always popular. And disruption is difficult. It’s difficult to get your way through that. But look, Mylan, here’s who we are as a company. Like I said, we’re fighters. We’ve been disruptors. We’ve been catalysts for change before. So this isn’t new. And I’m fortunate to have a company, a foundation, a family of 35,000 employees that are doing what we’re doing every day to provide that kind of access and affordability. What I realized, and what I went through this summer -- EpiPen was a window into a broken system. And what I’ve conveyed, and I believe the discussion continues to validate, this isn’t an EpiPen problem. This is a health care problem.” Watch the full interview tomorrow on “CBS This Morning,” as we take an exclusive look inside the company’s labs.  Continue Reading

Mylan CEO on EpiPen drug price controversy: “I get the outrage”

Pharmaceutical giant Mylan was at the center of criticism last year over rising drug prices. Mylan’s EpiPen became the lightning rod for scrutiny, as its price increased by nearly 500 percent over seven years. Mylan CEO says EpiPen controversy was “a window into a broken system” CBS News coverage of the life-saving device for allergies created public outrage and led to a congressional investigation. Last September, Mylan CEO Heather Bresch was called before Congress to explain why EpiPen’s price had soared from about $103.50 in 2009 to more than $608.61 in 2016. “Let’s just say I think a lot of misinformation and people had no idea, very uninformed about who Mylan is, the role we play in health care -- one out of every 13 prescriptions,” Bresch told “CBS This Morning” co-host Norah O’Donnell in her first in-depth interview since testifying on Capitol Hill. “We’re in everybody’s medicine cabinet.” We met inside Mylan’s one-million-square-foot manufacturing plant in Morgantown, West Virginia, as the first national news organization to go inside. “You can ask just about anybody and they say the price of drugs is too high,” O’Donnell said.  “And I agree with them,” Bresch said.  The cost of the life-saving drug inside each EpiPen injector is worth a couple of dollars. But the design is what’s added to the price tag. “Why did the price of EpiPen increase 500 percent over the past decade?” O’Donnell asked. “Because we realized there was an unmet need. … And so we made a conscious decision, the board, we put a business plan together to invest, to build public awareness and access,” Bresch said. “We’re now in over 70,000 schools across America. We’ve donated more than 800,000 free EpiPens… and remember that that price incorporates the entire supply chain. But it was that Continue Reading

Mylan CEO to testify on EpiPen price hikes

WASHINGTON - The head of the pharmaceutical company Mylan (MYL) will face lawmakers’ questions at a hearing next week on steep price increases for its life-saving EpiPen injector device. Mylan CEO Heather Bresch and an official from the Food and Drug Administration will testify before the House Oversight and Government Reform Committee. The committee’s leaders said in a statement that there is “justified outrage” from families and schools struggling to pay for the emergency allergy shots. The price has grown to $608 for a two-pack, an increase of more than 500 percent since 2007. The chairman, GOP Rep. Jason Chaffetz of Utah, and the top Democrat, Rep. Elijah Cummings of Maryland, said they also will examine ways to encourage greater competition in the EpiPen market. Several other committees are looking into the matter. The leaders of the Senate Homeland Security and Governmental Affairs’ investigations subcommittee said last week they have begun an inquiry into the company’s pricing and competition practices. The Senate Aging Committee has requested briefings on the issue. The chairman of the Senate Judiciary Committee has written several letters to Mylan demanding answers. Mylan’s Bresch is the daughter of Sen. Joe Manchin, D-W.Va. Continue Reading

Lawmakers slam Mylan CEO over EpiPen pricing

Last Updated Sep 21, 2016 7:23 PM EDT Mylan (MYL) CEO Heather Bresch got a rough reception from lawmakers in a hearing on Wednesday over the drugmaker’s steep price increases for its EpiPen anti-allergy product. Mylan has become ground zero for the debate over rising drug prices in light of revelations that the company has hiked prices for the EpiPen by more than 500 percent since 2007 when it acquired the treatment. In testimony submitted today before the House Committee on Oversight and Government Reform, the 47-year-old Bresch said it “troubles me greatly that the EpiPen product has become a source of controversy.”Nonetheless, Mylan has no plans to lower prices for the life-saving treatment, which isn’t covered by most insurance plans.Bresch took heavy fire from Republicans and Democrats on the House panel. Committee Chairman Jason Chafetz, R-Utah, snapped at Bresch when she said the company didn’t anticipate the public outcry over the price increase. He asked: “What did you think was going to happen?”Rep. John Duncan of Tennessee, who describes himself as a pro-business Republican, said he was “sickened” by the greed at Mylan. “Yet another drug company has jacked up the price of a lifesaving product for no discernible reason,” said Rep. Elijah Cummings, D-Maryland, the committee’s top-ranking Democrat.Added Rep. Stephen Lynch, D-Massachusetts: “It’s disgraceful what’s going on here. I think it’s disgusting.” According to the Centers for Disease Control and Prevention, allergies are the sixth-leading cause of illness, with an annual cost to society of $18 billion. Data from the Centers for Disease Control and Prevention indicates that food allergies result in more than 300,000 hospital visits annually for children under the age of 18. When Mylan acquired EpiPen as part Continue Reading

Mylan CEO mispresented company’s EpiPens profits during congressional hearing

The CEO of Mylan misrepresented the company’s EpiPen profits in a congressional testimony last week — by factoring in a tax rate that appears to have no basis in reality. Embattled CEO Heather Bresch told the House Oversight and Government Reform Committee her company makes only $100 in profit from a $608 two-pack of EpiPens. Mylan has faced fierce scrutiny this year for that price, which marks a 500% jump since 2007. But Bresch arrived at that number by adding a statutory corporate tax rate of 37.5%, according to a Securities and Exchange Commission filing first reported by The Wall Street Journal. In a statement, the company defended this murky math by calling that tax rate “standard.” “Tax is typically included in a standard profitability analysis and the information provided to Congress has made clear that tax was part of the EpiPen Auto-Injector profitability analysis,” the company said. But it does not appear to be standard for Mylan. The company paid a 7% tax rate in 2015, according to a previous SEC filing, after the drugmaker moved its headquarters to the Netherlands. Under its actual tax rate, Mylan’s EpiPen profits are $166 for a two-pack — 66% more than what Bresch said. The company said in a statement that any “lack of clarity wasn’t intentional,” but it did not explain why Bresch did not clarify this distinct before Congress. Rep. Elijah Cummings (D-Md.), a member of the House committee, said Mylan has until this Friday to turn over documents proving its profits. “We didn’t believe Mylan’s numbers last week during their CEO's testimony, and we don’t believe them this week either, which is why we gave them ten days from the date of our hearing to produce their internal files,” he said in a statement. Bresch said in her testimony that Mylan is expecting to sell four million EpiPen two-packs Continue Reading

Pharma CEO’s mother helped boost EpiPen sales nationwide with education group

A giant drug company under fire over the price of EpiPens received a sales boost with the help of an education group led by the CEO’s mother, a report revealed Tuesday. The price of the lifesaving Mylan product for severe allergic reactions jumped by over 500% since 2007 to $608 for a two-pack of the injector devices. Mylan CEO Heather Bresch will testify Wednesday at a Congressional hearing on “justified outrage” from families and schools. And an investigation by USA Today showed Bresch’s mother and the wife of Democratic West Virginia Sen. Joe Manchin, Gayle Manchin, helped the devices become required at schools nationwide during her time as president of the National Association of State Boards of Education. Both Mylan executives and officials with the nonprofit education denied any ulterior motives. Yet a former executive director at the Association told USA Today that Gayle Manchin once mentioned that her “daughter’s company” might donate to the group. “It just looked so bad to me,” said Brenda Welburn. “She becomes president and all of a sudden NASBE is saying EpiPens are a good thing for schools.” Mylan donated at least $25,000 in 2012 and $15,000 this year to the association, according to USA Today. The 2012 gift happened months before the group announced a new program “in collaboration with” a Mylan division about Epinephrine, the drug in EpiPens. “It is essential that state and school policies ensure access to epinephrine auto injectors and training of school personnel to respond in a timely manner to students with life-threatening allergic reactions,” then-NASBE executive director Jim Kohlmoos said in a statement at the time. A discussion guide released by the group in November 2013 outlined the dangers of anaphylaxis, which is a life-threatening allergic reaction to food, medication, insect stings or other triggers. Continue Reading

Mylan CEO saw more than 600% pay increase as company repeatedly raised EpiPen price

The pharmaceutical CEO whose company raised the price of EpiPens by more than 400% was rewarded with a 671% raise. Heather Bresch and other executives at Mylan Pharmaceuticals have been criticized for increasing the price of the devices to prevent fatal allergy reactions from less than $100 for a pair in 2007 to more than $500 today. Bresch, who was president in 2007 and has since become chief executive of the global pharma giant, went from making $2,453,456 nine years ago to $18,931,068 last year, according to filings from the company. The pay increase, first reported by NBC News, came as Mylan repeatedly raised the price of the live-saving epinephrine device by increments of 5, 10 and 15%. EpiPens make up 40% of the company’s operating profits, according to Bloomberg, who said that Bresch was behind the push to market them to the worried parents of children with allergies. The report said that the devices are sold for $85 in France, though that may change as Mylan is purchasing the company that offers them for less. Allergist Dr. Douglas McMahon, who is trying to make a less expensive alternative for his patients, told the Daily News last week that EpiPens only cost a few dollars to manufacture. Mylan’s stock price surged after their price increase strategy, going from as low as $14.84 per share in 2007, when it first bought EpiPens, to as high as $49.09 on Monday. Attention given to the rising price of the pens has prompted calls from legislators for an explanation. Connecticut Sen. Richard Blumenthal called on Bresch to immediately lower the price after what he said were “exorbitant” increases. Queens Rep. Grace Meng called on the House Oversight and Government Reform Committee to hold a hearing on the price gouging. Mylan said in a statement Monday, “Ensuring access to epinephrine – the only first-line treatment for anaphylaxis – is Continue Reading

Under fire, Mylan to offer generic EpiPen for 50% less

Drugmaker Mylan said Monday that it will offer a generic version of the life-saving allergy treatment EpiPen for half the list price of the brand-name treatment after it became the center of a national controversy over skyrocketing drug prices.The move marks a sharp shift in Mylan's position after it vigorously defended multiple increases over the years that resulted in a list price of about $600 for a two-pack of the emergency injection treatment, up from about $100 in 2009.​The generic version of EpiPen "will be identical to the branded product, including device functionality and drug formulation," Mylan said in a statement."It's highly unusual for a generic product to come out in this way," Marianne Udow-Phillips, director of the Center for Healthcare Research & Transformation at the University of Michigan, said Monday . "It clearly shows how much pressure Mylan was under. It's still a huge profit margin for them."The company's decision was revealed hours before Republican and Democratic leaders of the U.S. House Committee on Oversight and Government Reform launched an investigation into EpiPen price increases in a rare show of bipartisanship that underscores the depth of the opposition to Mylan's strategy.Committee chairman Jason Chaffetz, R-Utah, and ranking member Elijah Cummings, D-Md., requested a slew of documents from Mylan, including details of EpiPen profits and sales, lobbying data, internal cost figures and federal health reimbursement numbers.Mylan has "a virtual monopoly over the epinephrine auto-injector market," the lawmakers said in a letter to Bresch. "While families and schools are struggling to keep up with your company's unreasonable price increases, Mylan has profited richly from its pricing strategy."The committee's letter, which requested a briefing by Sept. 6 and documents by Sept. 12, paves the way for a potential congressional hearing on the matter.The company will surely cite its decision to Continue Reading

Mylan to pay $465M settlement over EpiPen, cuts earnings outlook

Mylan, the embattled maker of allergy treatment EpiPen, lowered its 2016 earnings guidance Friday after it agreed to pay $465 million in a settlement with federal regulators over its pricing practices.“The terms of the settlement do not provide for any finding of wrongdoing on the part of Mylan Inc. or any of its affiliated entities or personnel,” the Canonsburg, Pa.-based company said.Mylan has been under investigation by federal and state regulators for repeatedly raising prices of EpiPen over the years, which resulted in a list price of about $600 for a two-pack of the emergency injection treatment, up from about $100 in 2009.The settlement specifically refers to the question of how EpiPen was classified with the Centers for Medicare and Medicaid Services (CMS), the federal agency that runs the Medicaid insurance program for the poor. CMS said it advised Mylan on multiple occasions that the drugmaker had incorrectly classified EpiPen as a generic treatment for the Medicaid Drug Rebate program, resulting in the company paying lower rebates to state health programs.To lower the cost of drugs, the program requires manufacturers to have a national rebate agreement in exchange for state Medicaid coverage. Companies generally pay lower rebates for generic drugs than branded drugs, which are also called "innovator" drugs.The settlement terms resolve "all potential rebate liability claims" by federal and state governments as to whether the product should have been classified as a branded drug for CMS, Mylan said.Mylan will include a pretax charge of about $465 million in the quarter that ended on Sept. 30 due to the settlement. And it now expects full-year 2016 adjusted earnings per share (EPS) to be between $4.70 and $4.90. That's lower than the previously announced guidance of $4.85 to $5.15."Much of the impact of this guidance change will occur in the third quarter," it said. Continue Reading

Mylan’s generic EpiPen hits market after fury over dramatic price hikes

The generic version of allergic-reaction treatment EpiPen will hit U.S. pharmacies beginning next week after a firestorm over manufacturer Mylan's sharp price increases for the name-brand version.The life-saving treatment's skyrocketing price tag enraged consumers, Congress and drug industry watchdogs after multiple increases over the last several years resulted in a list price of more than $600 for a two-pack, up from about $100 in 2009.In August, Mylan announced plans to introduce a generic version for a wholesale cost of $300. Most patients pay significantly less for the treatment because it's partially covered by insurance or they qualify for discounts, but some pay the full cost out of pocket.The company will continue to sell the name-brand EpiPen. But the generic "has the same drug formulation and device functionality" and "is administered in the same way."The generic version's box is labeled, "Epinephrine Injection, USP Auto-Injectors," with two dosage options: 0.3 milligrams and 0.15 milligrams.The device delivers an emergency treatment of epinephrine to counteract anaphylaxis, which can be deadly.Critics have cited Mylan as an example of exorbitant price increases that are becoming rampant in the pharmaceutical industry."Americans are rightfully concerned about rising drug prices, and now more than ever patients and families across this country are standing at the pharmacy counter struggling to pay for their medications," Mylan CEO Heather Bresch said in a statement."While it is important to understand the outdated and complex system that determines what someone pays for medicine in the U.S., hardworking families don't need an explanation, they need a solution. This is why we took decisive action with our EpiPen product and have launched the first generic version at half the (wholesale) price."Mylan has also come under fire for classifying EpiPen incorrectly as a generic treatment for the Medicaid Drug Rebate program, resulting in the company doling Continue Reading