WASHINGTON -- There may have been 4 hours of testimony in Wednesday's House Oversight & Government Reform Committee hearing on the rising price of EpiPens, but Rep. Elijah Cummings (D-Md.) didn't think very much of it.
"You might as well have taken the Fifth [and refused to testify], with the kind of information we've gotten here today," Cummings said to the hearing's main witness, Heather Bresch, the CEO of Mylan, maker of the epinephrine auto-injector at the center of the issue. "I don't know what your lawyers have been telling you, [but] I don't think you've been frank with us."
EpiPen pricing has been a focus of controversy in recent weeks. In 2004, pricing for a package of two auto-injectors stood at about $100 (in 2016 dollars to adjust for inflation), but the price of the anaphylaxis treatment has gradually risen since then to $600, prompting a social media campaign by patients and families to persuade Mylan to cut the price. Several critics have noted that the actual cost of the epinephrine included in the auto-injector is about $1.
Bresch testified that even though the price may be $600, the company only receives about $274 of that amount, and after subtracting for manufacturing and other costs, Mylan makes a profit of $50 per pen -- a number that committee chair Jason Chaffetz (R-Utah) said he found "hard to believe."
She also noted that the majority of customers -- because of discount programs and insurance reimbursement -- pay less than $50 per two-pack of EpiPens. But again lawmakers were skeptical. "I just don't buy the idea that the majority of consumers are paying less than $50," said Chaffetz. "Show it to us."
To address the cost issue, Mylan recently announced it was going to launch its own "authorized generic" version of the EpiPen, at a cost of $300. Although Bresch said the company will be making much less profit on the generic pens than the brand-name ones, Chaffetz suggested that because the company will be directly shipping the generic to customers rather than going through distributors, it will actually be keeping more money -- all $300 -- than the $274 it makes on the brand-name drug.
Rep. Buddy Carter (R-Ga.), a pharmacist, also took Bresch to task for insisting that Mylan's new generic would solve the problem. "Don't go there ... you know I know that. It's a crock; it is. There is no difference whatsoever," he said. "You are not doing a favor by that; you could have dropped the price of [brand-name] EpiPens just as well. You did not want to cut the price on the brand because you would not get the rebates you are getting now."
Carter also pointed a finger at the pharmacy benefit management companies (PBMs) and called for an investigation into their pricing practices. "What we do know is this: prescription drug prices have soared and so have the profits of PBMs."
Bresch's high salary -- nearly $19 million last year -- also came under scrutiny at the hearing. "I'm a very conservative, pro-business Republican, but I'm really sickened by what I've heard here today and what I've read before about this situation," said Rep. John Duncan, Jr. (R-Tenn.). "Nobody can really earn or deserve $19 million a year."
The other witness, Doug Throckmorton, MD, deputy director of the FDA's Center for Drug Evaluation and Research, also came in for a lot of criticism, mainly over the length of time it takes FDA to approve a drug. "I wish we were talking about why ... this same thing from the same manufacturer costs $350 in Europe," said Rep. Mick Mulvaney (R-S.C.). "In fact, I think you can buy this over the counter for $75 ... One reason is that there are lots more people making this stuff [over there]."
"If you really charge $600 ... why aren't more people rushing in to make it? Because it's so darn hard to get the stuff approved."
Throckmorton noted that starting on Oct. 1, the FDA has committed to taking a maximum of 10 months to review a new drug application. But that didn't seem to mollify committee members. "The median time it takes for FDA to approve a generic is 47 months -- that doesn't sound like expedited approval to me," said Duncan. "The FDA needs to speed up its action and it needs to allow more competition, and it's not doing that now."
Committee members also discussed what they could do to prevent more drug prices from rising. Rep. Stephen Lynch (D-Mass.) noted that the Department of Veterans Affairs probably has negotiated a special price for EpiPens. "Maybe that's what we should do with Medicare and Medicaid and everyone else; let them negotiate their own prices with pharmaceutical companies," he said.
Looking directly at Bresch, he added, "I know it's not your intention, but you may have helped Congress get around this issue by showing blatant disrespect for the people who need this medication. People in my district can't do it for $608; they just can't do it. And a lot of those people don't have discounts."
Mulvaney also took Bresch to task for the company's successful effort to lobby Congress to give states financial incentives to maintain an emergency supply of epinephrine auto-injectors in their public schools; the so-called "EpiPen" bill was signed into law in 2013 by President Obama.
"You get what you deserve," Mulvaney said. "You've been in these hallways asking us to make people buy your stuff ... I have to defend both my Republican and my Democratic colleagues because you asked for it. If you want to lobby us to make people buy your stuff, this is what you get."