4 questions we’d like answered in Heather Bresch’s congressional appearance

After weeks of furor over high EpiPen prices, lawmakers have finally gotten their wish: the company’s CEO in the hotseat. Mylan Chief Executive Heather Bresch will appear before the House Committee on Oversight and Government Reform Wednesday to answer questions about the rising cost of EpiPens — the first time she’s spoken publicly about the matter since a CNBC interview at the end of August.

Dozens of members of Congress have called for scrutiny of the company — and also on the gatekeeping Food and Drug Administration — since news reports earlier this summer called attention to price hikes of over 450 percent since 2004.

Bresch will appear alongside the FDA’s Dr. Doug Throckmorton, deputy director of the Center for Drug Evaluation and Research, which regulates prescription drugs, before the House committee at 2 p.m. EST.

The committee is looking for a lot of information, including sales data, lobbying disclosures, and Mylan’s contracts with the devices’ manufacturer, Meridian Medical Technologies, which is a subsidiary of Pfizer. And if Bresch’s August interview with CNBC is any indication, the hearing may be more productive than the committee’s last hearing with a publicly shamed pharmaceutical executive, Martin Shkreli. At that February hearing, Shkreli declined to answer questions, invoking the Fifth Amendment. (The CEO of Valeant Pharmaceuticals, Michael Pearson, did speak before the Senate Special Committee on Aging in April, admitting mistakes in aggressively raising prices.)

What will Bresch and Throckmorton say? Here are some questions to which STAT wants to know the answers.

1. Why are patients paying so much more for EpiPens?

We all know that EpiPen prices have increased. But a lot of other things have also been increasing, like insurance premiums — which means that people are paying more for health care out of pocket before their insurance kicks in. That could be a factor in families feeling the pinch. In addition, it’s likely Bresch will point to other players — pharmacy benefit managers and insurance companies among them — as partly to blame for rising consumer costs. And if she does, the question is, who is getting what cut, and how has that changed over time?

2. Why is there no generic EpiPen?

This is a question the FDA will likely have to answer. In August, five senators wrote to FDA Commissioner Dr. Robert Califf expressing “concern that Mylan has not faced much competition for its product,” asking questions like why EpiPens require a prescription, and how close we might be to a true generic alternative. (Mylan announced in the wake of public outcry that it would start marketing an “authorized generic” which would be identical to the EpiPen but marketed differently. Since this will be sold by Mylan, it would not increase competition in the marketplace.)

The FDA has come under criticism for having a backlog of thousands of unapproved generic drug applications. One of them is for a generic EpiPen that Teva Pharmaceuticals applied to market. In February, the FDA told Teva they needed to address “certain major deficiencies,” but neither the government nor the company has shared any more information.

But it’s not all the FDA’s fault: Lawsuits have also had a hand in delaying the marketing of a real generic. The Pfizer subsidiary (King Pharmaceuticals) that owns the company that manufactures the EpiPen (Meridian) sued Teva in 2009 and Sandoz in 2010 for patent infringement. The Teva case settled and the Sandoz case is pending. Teva is currently planning to market a generic EpiPen in 2017 or 2018, the president and CEO of their global generic medicines group said in September.

3. Has Mylan been overpaid by government insurance programs?

Members of Congress have called on the Department of Health and Human Services to look into whether Mylan has been cheating the public out of its money by classifying EpiPens as generic drugs rather than brand-name drugs for the purpose of a government reimbursement program. The House Committee on Energy and Commerce has even asked the HHS watchdog — the HHS Office of the Inspector General — to see if HHS has been dragging its feet on this issue.

4. What should the relationship be between drug marketing companies, insurance companies, and the public?

This is a big question that likely won’t get resolved in a few hours on Capitol Hill. But one of the most interesting moments of attempted transparency in Mylan’s response to public outrage was a diagram the company released showing a price breakdown of the EpiPen.

Tomorrow’s hearing could help move the conversation forward by shedding further light on how the money flows. How much money does Mylan deserve for marketing and promoting a drug that is off patent, and a delivery system that another company developed? What are the price cuts that various players take between the manufacturer and the consumer? And where did it go awry in this case?

In her CNBC interview, Bresch was asked if she was ready to break the system. “I am absolutely ready to work with Congress to make it happen, not to have a PR sound bite,” she said.

Wednesday will be a test of both her and Congress’s willingness.