By Kerry Young, CQ Roll Call
September 21, 2016 -- A senator's daughter who leads a blue-chip drug company has become the face of public outrage over rising drug prices.
Emerging details about Mylan N.V.'s marketing of the widely used EpiPen allergy shot appear likely to keep drug costs on the congressional agenda through the end of the year. The focus on drug prices began gaining traction a year ago, when Martin Shkreli gained notoriety as the then-leader of Turing Pharmaceuticals by increasing the price of a different generic drug to treat a rare infection from $13.50 to $750 a pill.
The House Oversight and Government Reform Committee on Wednesday held a hearing with Mylan Chief Executive Heather Bresch, the daughter of Sen. Joe Manchin III, D-W. Va. Jason Chaffetz, R-Utah, the panel's chairman, questioned why there are not competitors to drive down the cost of EpiPen, which now has a list price of roughly $600 for a two-injection pack.
"The market forces aren't at work," Chaffetz said.
EpiPen's sales could reach $1.1 billion this year, said Rep. Elijah Cummings of Maryland, the ranking Democrat on the House Oversight and Government Reform Committee, citing documents obtained by the panel. In 2008, just after Mylan's acquisition of the product, sales were about $184 million.
News stories also have focused on Bresch's payouts from Mylan. Mylan reported that her total compensation was $25.9 million for 2014 and $13 million last year, plus an additional almost $6 million of her taxes that the company paid, according to a regulatory filing. Mylan also requires Bresch to use its corporate aircraft for business and personal purposes, according to a regulatory filing.
Lawmakers have seized on the rewards given to Bresch and other Mylan executives since their best-known product, the EpiPen, put a dent in many family budgets. Cummings said Mylan executives grew "filthy rich" at the cost of American consumers.
The widely used EpiPen has moved to center stage of the debate around drug prices. A top Food and Drug Administration (FDA) regulator, who oversees most drug approvals, touched on this product in her opening statement for a Senate Agriculture Appropriations Subcommittee hearing, also Wednesday, on generic drugs.
Generic drugmaker Teva stumbled earlier this year in its efforts to win FDA approval of a copycat version.
"At FDA, we are aware of the recent spike in the price of the EpiPen," said Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, at the Senate hearing. "While there are currently no FDA-approved generic epinephrine auto-injectors, we stand ready to quickly review additional applications that come to us from both generic and innovator drug companies."
Separately, Rep. Lloyd Doggett, D-Texas, a senior member of the House Ways and Means Committee, requested that the Federal Trade Commission investigate reports that Mylan prohibited schools from purchasing competitors' products as a condition of receiving discounted EpiPens, and to determine whether these agreements violated federal antitrust laws.
The Senate Judiciary Committee also has taken a strong interest in questions about Mylan's business strategies and the lack of competition for its EpiPen.
The product is a shot of the generic drug epinephrine delivered in what's meant to be an easily used "pen" injection device. The convenience of this administration is a draw for parents and others who may need to help someone facing life-threatening anaphylaxsis without much training or preparation.
At the House hearing, Cummings urged his fellow lawmakers to look beyond the outrage surrounding EpiPen and the rise in price for a generic drug by Shkreli's former firm Turing Pharmaceuticals and look broadly at costs.
"We need solutions. It's time for Congress to act. We will hold today's hearing, just like we held our previous hearings," Cummings said in a statement prepared for the hearing. "But it's time to start legislating. It's time to start doing our job and passing laws to rein in these out-of-control drug companies."
Doggett and Rep. Peter Welch, D-Vt., had arranged a Wednesday briefing for their fellow House Democrats with advocates on another drug funding issue—an Obama administration effort to control Medicare spending on cancer drugs and other treatments administered in doctors' offices. The so-called Part B drug model is a test of Medicare payments that the administration proposed in March. Opposed by many Republicans and some Democrats, the plan is the Obama administration's jab at the industry's rising prices but is likely to be scaled back from the proposed version.
Family Ties
Manchin's wife, who is Bresch's mother, helped foster use of EpiPen in her role as an education advocate, according to a CQ Roll Call article Tuesday that followed a USA Today report that day. Gayle Manchin served as president of the National Association for State Boards of Education in 2012, the group said. Kristen Amundson, executive director of NASBE, said in a statement Tuesday that the group stands by "the validity and usefulness of the work NASBE has done around epinephrine."
"Following passage of federal legislation encouraging states to require schools to stock epinephrine, legislatures in over a dozen states passed laws in 2012-13 governing epinephrine and anaphylaxis response," Amundson said. "NASBE recognized the important role state boards of education would play and stepped in to help them set policies that would ensure students' health and safety."
Manchin in a separate statement recapped his wife's education credentials, including her time spent as a teacher. "She served with distinction and has received universal praise for her commitment to education and the children of West Virginia," Manchin said. "She is held in the highest regard for her compassion, honesty and devotion by me and all who know her."
Manchin's connection to Mylan through his daughter drew scrutiny in 2014 when he introduced a bill to ban the painkiller Zohydro. The drug was considered a rival to fentanyl, a product sold by Mylan. A Manchin spokesman told CQ Roll Call at the time that the senator's "office focuses on what is best for the people of West Virginia and nothing else." Manchin, whose state was hard hit by the opioid crisis, has been active on other measures intended to address narcotic abuse.