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Hippocratic Oath?
It’s a bit out of fashion.
Some choose their own vows.

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Summaries Of The News:


4. Mylan CEO: We Wish We Had Better Anticipated Fallout, But Price Hikes Were Warranted

Mylan CEO Heather Bresch will face congressional fire Wednesday at a hearing to investigate the EpiPen price spike. In prepared testimony, Bresch defends the costs as a necessary investment. Meanwhile, Bresch's mother, as National Association of State Boards of Education, spearheaded an effort to get EpiPens in schools.

The Associated Press: Mylan CEO Set To Defend EpiPen Prices Amid Public Outcry
The head of pharmaceutical company Mylan is defending the cost for life-saving EpiPens, signaling the company has no plans to lower prices despite a public outcry and questions from skeptical lawmakers. "Price and access exist in a balance, and we believe we have struck that balance," Heather Bresch says in prepared testimony released by the House Oversight and Government Reform Committee ahead of her Wednesday appearance before the panel. (Jalonick, 9/21)

Stat: CEO: Mylan Failed To Properly Heed Concern Over EpiPen Prices
The chief executive of Mylan plans to defend the price of EpiPens before Congress on Wednesday, but will acknowledge that the drug maker should have foreseen consumer concern over rising costs, according to an advance copy of her remarks. “Looking back, I wish we had better anticipated the magnitude and acceleration of the rising financial issues for a growing minority of patients who may have ended up paying the [list price] or more,” Heather Bresch plans to say. “We never intended this.” Bresch is scheduled to testify before the House Committee on Oversight and Government Reform amid a public outcry over the price of EpiPens and congressional scrutiny. (Sweltlitz, 9/20)

Bloomberg: Mylan CEO Regrets Patient Blowback, But Not Expanded EpiPen Use
Mylan NV’s chief executive officer will tell Congress Wednesday that although she regrets some patients’ financial difficulties affording the EpiPen allergy shot, lawmakers should still recognize that the company has increased access to the drug. CEO Heather Bresch will testify before the U.S. House Committee on Oversight and Government Reform and face questions from lawmakers about how the company raised the cost to about $600 for a two-pack, from $57 a shot when Mylan acquired the rights to sell the product in 2007. (Edney, 9/20)

Bloomberg: Man Behind EpiPen Gambit Stays Away As Mylan CEO Faces Congress
Heather Bresch will face the proverbial lash from Congress on Wednesday over the escalating cost of Mylan NV’s EpiPen. Her boss won’t. Robert J. Coury acquired the rights to sell the emergency allergy antidote in 2007 when he was Mylan’s chief executive officer. At the time, the EpiPen cost about $50 a shot. When Coury stepped down as CEO and became the company’s executive chairman in 2011, the price was about $90, according to SSR Health. Now, it’s sold in a two-pack for $600 and, thanks to federal legislation, it’s required in many schools. (Hopkins, 9/20)

USA Today: Mylan CEO's Mother Used Position With Education Group To Boost EpiPen Sales Nationwide
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. (O'Donnell, 9/20)

In other news, Medicare spending on EpiPens skyrocketed between 2007 through 2014, a committee calls for an investigation into how the company billed Medicaid, and the controversy is throwing renewed focus on rebates —

Reuters: Medicare EpiPen Spending Outpaces Prescription Growth: Kaiser Report
U.S. government spending on Mylan Inc's EpiPen in the Medicare program for seniors and the disabled rose 1,151 percent from 2007 through 2014, while the number of EpiPen users grew 164 percent, the Kaiser Family Foundation said on Tuesday in an analysis. The spending figure excludes after-market manufacturer rebates that Mylan paid to the private insurers who manage the Medicare Part D program for pharmacy drugs on behalf of the government, it said. (Humer, 9/20)

Reuters: U.S. Senate Finance Committee Asks For Mylan EpiPen Rebate Investigation
The U.S. Senate Finance Committee on Tuesday said it had asked the U.S. Department of Health and Human Services to investigate the rebates to state Medicaid programs for Mylan Inc's EpiPen treatment. Mylan, which has raised the U.S. price for a pack of two EpiPens from less than $100 when it acquired the product in 2007 to more than $600, also faces scrutiny from New York Attorney General Eric Schneiderman and West Virginia. (Humer, 9/20)

Bloomberg: Blame Game: $130 Billion Fees That Drugmakers Say Push Up Prices
When Mylan NV ’s chief executive office testifies before Congress Wednesday about the company’s EpiPen allergy shots, part of her explanation should shed light on a corner of the U.S. health-care system that drugmakers say drives up prices but is little-discussed outside the industry: rebates. Those rebates, which are fees pharmaceutical companies pay to distribution intermediaries, are likely to be at the crux of CEO Heather Bresch’s defense: Mylan actually sees only a portion of the $600 list price that has drawn outrage from lawmakers and patients. Bresch will probably point to a “broken system” that incentivizes drugmakers to raise prices in order to secure lower co-pays for their products, Wells Fargo analyst David Maris said. (Koons, 9/21)

Reuters: Mylan Shares Languish At Low Valuation As EpiPen Hearing Nears
Shares of Mylan NV are trading at historically low valuations as the company's chief executive officer is set to face a congressional grilling on Wednesday over the price of its EpiPen emergency allergy treatment. The stock is trading at 7.5 times estimated earnings for the next 12 months, holding near its lowest in at least 30 years and well below its five-year average of 11 times, according to Thomson Reuters Datastream. (Krauskopf, 9/20)

And West Virginia's attorney general subpoenas Mylan —

Bloomberg: Mylan Investigations Mount As West Virginia Opens Fraud Probe
The inquiry, led by State Attorney General Patrick Morrisey, seeks to force Mylan to turn over company documents related to EpiPen. Similar requests have been made in the last month by lawmakers in Washington, and on Wednesday Mylan Chief Executive Officer Heather Bresch is to testify at a congressional hearing about the product’s price. The state attorneys general in Minnesota and New York also have inquiries, as do several congressional committees. (Feeley and Langreth, 9/20)

USA Today: W.Va. Seeks Mylan Records On EpiPen Price Hikes
West Virginia's top legal official Tuesday sought court enforcement of a subpoena that seeks answers from Mylan N.V. (MYL) about spiraling price hikes the pharmaceutical company imposed for its EpiPen lifesaving allergy injectors. Filed on the eve of congressional hearings scheduled over the increases, the court petition is part of an investigation that could lead to Medicaid fraud charges against the Europe-based company. (McCoy, 9/20)

5. FDA Staffers Troubled By Top Official's Rush To Approve Muscular Dystrophy Drug

Documents show that there were concerns Drug Center Director Janet Woodcock was influenced by public pressure. Meanwhile, Sarepta's stock is soaring on the approval news.

Politico Pro: FDA Scientists Worry Director Bowed To Political, Financial Pressures In Controversial Drug Approval
FDA’s decision to approve a controversial Duchenne muscular dystrophy drug this week has raised questions within the agency about whether its top drug regulator pushed too aggressively to greenlight an unproven treatment — for a rare disease that kills young people and stirs strong emotions. Internal documents detailing FDA’s decision to ultimately approve the drug for types of Duchenne reveal that critics within the agency saw FDA’s Drug Center Director Janet Woodcock as too influenced by patient advocates, who mounted an aggressive campaign for approval despite shaky evidence of the treatment’s benefits. Some worried that Woodcock let politics and public pressure — and even the drug company’s financial considerations — influence the approval Monday of a $300,000-per-year drug based on questionable science. (Carlin-Smith, 9/20)

Boston Globe: Reborn With Its Duchenne Drug, Sarepta Sees Its Stock Soar 14%
Given up for dead just five months ago, Sarepta Therapeutics Inc. has suddenly been reborn as one of the hottest stars in Kendall Square’s biotech constellation. Sarepta’s stock closed near a record high Tuesday, up nearly 14 percent to $55.73, a day after the Food and Drug Administration issued its surprise approval of the company’s experimental drug for Duchenne muscular dystrophy. The run-up boosted Sarepta’s market value to $2.6 billion, and some analysts are now suggesting it may be an attractive takeover candidate. (Weisman, 9/20)

In other pharmaceutical news —